[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"idiopathic-hypersomnia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:idiopathic-hypersomnia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,47,74,103,134,162,185,207,231,254,276,310,337,359,436,842,864,891,912],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100631393","phase-3-a-phase-3-efficacy-and-safety-study-of-hbs-301-in-participants-with-idiopathic-hypersomnia-ih-100631393",false,"NCT07500090","A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)","A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) Followed by an Open-label Extension","Inclusion Criteria:\n\n* Has a current documented diagnosis of IH per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or Text Revision (ICSD-3-TR) criteria with confirmatory polysomnogram (PSG) with multiple sleep latency test (MSLT; and if applicable, a 24-hour PSG report or an actigraphy report with sleep log) on file that led to the diagnosis and was completed within the last 10 years.\n* Has EDS.\n* Has moderate to very severe symptoms of IH.\n* If taking a permitted chronic concomitant medication or supplement, including nonprohibited antidepressants or wake-promoting agents, must be on a stable dose for at least 3 months prior to Screening and agree to continue at that stable dose for the Double-blind Treatment Period of the study. As-needed use of any treatment that could affect daytime sleepiness (including but not limited to stimulants, modafinil, and armodafinil) used on an as-needed basis is not permitted.\n\nExclusion Criteria:\n\n* Has hypersomnia due to another medical disorder.\n* Has a history of pitolisant use within 5 half-lives prior to Screening.\n* Has a primary diagnosis of psychiatric illness, including depression, that is not well controlled.\n* Has a history of moderate or severe hepatic impairment.\n* Has a body surface area (BSA)-corrected estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin.\n* Has a known history of long QT syndrome or any significant history of a serious abnormality of the electrocardiogram (ECG).","ALL","18 Years",{"count":19,"type":20},248,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).",[26],"Idiopathic Hypersomnia",[28,29,30,31,32,33],"pitolisant","HBS-301","idiopathic hypersomnia","excessive daytime sleepiness","sleep inertia","fatigue","RECRUITING","2026-06-30",{"date":37,"type":38},"2026-07-02","ACTUAL",{"date":40,"type":38},"2026-03-16",{"date":42,"type":20},"2028-10",{"name":44,"class":45},"Harmony Biosciences Management, Inc.","INDUSTRY",22,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100642659","phase-2-a-study-of-tak-360-in-people-with-narcolepsy-or-idiopathic-hypersomnia-100642659","NCT07646678","A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia","A Long-term Extension Trial to Evaluate the Safety and Tolerability of TAK-360 in Participants With Selected Central Hypersomnia Conditions","Key Inclusion Criteria:\n\n1. Participant is willing and able to understand and fully comply with trial procedures and requirements.\n2. Participant has a confirmed diagnosis of either NT1, NT2, or IH, and has completed the treatment period of a parent TAK-360 trial.\n3. Participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form (ICF) and any required privacy authorization before the initiation of any trial procedures.\n\nKey Exclusion Criteria:\n\n1. Participant has a positive pregnancy test or is lactating\u002Fbreastfeeding.\n2. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).\n3. The participant has developed a new medical disorder associated with excessive daytime sleep (EDS).\n4. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.\n5. Participant has developed a new history of seizures.\n6. Participant has experienced clinically significant head injury, per investigator opinion.\n7. Participant has developed a history of cerebral ischemia, transient ischemic attack (less than \\[\\\u003C\\] 5 years ago), or cerebral haemorrhage.\n8. Participant has developed a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.\n9. The participant has been diagnosed with medically significant thyroid disease, known functional hepatic impairment, or other severe chronic medical condition other than the central hypersomnolence disorder.\n10. Participant has developed a history of cancer in the past 5 years.","71 Years",{"count":56,"type":20},500,[58,23],"PHASE2","Central hypersomnia conditions are a group of sleeping disorders where the brain has trouble keeping a person awake during the day (called excessive daytime sleepiness or EDS). These conditions usually include narcolepsy (type 1 and 2) and idiopathic hypersomnia (IH). Narcolepsy type 1 (NT1) includes sudden muscle weakness while you stay awake, called cataplexy, often triggered by strong emotions. Narcolepsy type 2 (NT2) does not include cataplexy. People with narcolepsy typically feel refreshed by short naps. People with IH feel extremely sleepy during the day, and do not feel refreshed by sleep. Waking up from sleep is difficult. This is common in the morning and also when waking up from long naps.\n\nThe study wants to learn about TAK-360 when taken over a long time period; this is called a long-term extension or LTE study. The main aim of this LTE study is to find out how well participants with NT1, NT2, and IH tolerate TAK-360 over a longer period (long-term tolerability) and to learn how safe TAK-360 is when given over a longer period of time (long-term safety).\n\nParticipants who completed one of the TAK-360 parent studies can join this study if they meet the study rules. Parent studies include TAK-360-2001(NCT06952699), TAK-360-2002 (NCT06812078), or other TAK-360 studies that evaluate the TAK-360 medicine. All participants will receive TAK-360 in this study. They will either receive the same dose as they did in the parent study, or the closest dose available in this LTE study. Participants who received placebo (the placebo looks just like TAK-360 but does not have any medicine in it) in their parent study will receive one of the TAK-360 doses available in this study. Placebo will only be used to not reveal the dose of TAK-360 from parent studies to investigator, participants, and sponsor. Sponsor, investigators and participants will not know which TAK-360 dose was used in the LTE study as long as the parent study is ongoing.\n\nThe participants will have to visit the clinic multiple times during this study.",[26,61,62],"Narcolepsy Type 1","Narcolepsy Type 2",[64],"Drug Therapy","2026-06-25",{"date":35,"type":38},{"date":68,"type":38},"2026-06-11",{"date":70,"type":20},"2031-06-15",{"name":72,"class":45},"Takeda",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100580921","phase-2-a-study-to-evaluate-the-safety-and-effectiveness-of-alks-2680-in-subjects-with-idiopathic-hypersomnia-100580921","NCT06843590","A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia","A Phase 2, Randomized, Parallel-Group, Double-Blind, Dose-Range-Finding Study to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Idiopathic Hypersomnia (Vibrance-3)","Vibrance-3","Inclusion Criteria:\n\n* Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits.\n* Meets the diagnostic criteria of Idiopathic Hypersomnia according to ICSD-3-TR guidelines, confirmed by the diagnostic evaluations (PSG\u002FMSLT\u002Factigraphy) within the previous 10 years\n\nExclusion Criteria:\n\n* Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle\n* Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject's ability to complete the study\n* Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1\n* Is currently pregnant, breastfeeding, or is planning to become pregnant during the study","70 Years",{"count":84,"type":20},126,[58],"The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets",[26],[26,89,90,91,92,31],"IH","sleep","sleep disorder","orexin-2 receptor agonist","2026-06-22",{"date":95,"type":38},"2026-06-24",{"date":97,"type":38},"2025-05-22",{"date":99,"type":20},"2026-11",{"name":101,"class":45},"Alkermes, Inc.",50,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":110,"sex":16,"minAge":17,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":133},"100553304","deciphering-the-interactions-between-food-intake-sleepiness-and-nighttime-sleep-quality-in-patients-with-type-1-narcolepsy-and-idiopathic-hypersomnia-100553304","NCT06484348","Deciphering the Interactions Between Food Intake, Sleepiness, and Nighttime Sleep Quality in Patients With Type 1 Narcolepsy and Idiopathic Hypersomnia","NARCOFOOD","Inclusion Criteria :\n\n* Patients with NT1 or IH (ICSD-3-TR) or Healthy Controls without sleep disorder\n* Familiar use of a smartphone\n\nExclusion Criteria :\n\n* Untreated moderate or severe sleep apnea syndrome;\n* Cognitive disorders incompatible with the protocol;\n* Unstable treatment or treatment with sodium oxybate;\n* Unstable medical or psychiatric pathology;\n* Shift work;\n* Pregnancy or breastfeeding;\n* Diabetes",true,"65 Years",{"count":113,"type":20},76,[115],"NA","Links between sleep and food intake are manyfold. In healthy individuals, sleep deprivation promotes obesity by stimulating food intake of high glycemic index (GI) foods. Conversely, high GI foods induce sleepiness. Obesity is observed in 30-50% of patients with Narcolepsy type 1 (NT1). Its determinism may involve transient changes in basal metabolism at the early stage of the disease, eating disorders, disrupted nighttime sleep and sleepiness. In contrast, patients suffering from idiopathic hypersomnia (IH), whose nocturnal sleep is generally long and of good quality, rarely present with obesity. By studying the relationships between diet, body composition and sleep patterns in these two populations and in healthy controls, the NARCOFOOD study aims to provide a better understanding of the determinants of obesity in narcolepsy and, more generally, of the effects of food intake on sleepiness.\n\nPatients will be recruited at the Lyon and Clermont-Ferrand sleep centers and Controls at the Lyon Neuroscience Research Center or through communications to the general public. Data from clinical evaluation (including body mass index and body composition), and questionnaires (sleep quality, insomnia, sleepiness, anxiety and depression, impulsivity, eating behaviors) will be collected. During 4 days, at home, the following parameters will be explored : 1) eating behaviors (meals' photos) and sugar consumption (FreeStylePro sensor measuring interstitial glucose) 2) sleep\u002Fwake rhythm (diary and actigraphy) 3) nocturnal sleep parameters (Somfit device) 4) sleepiness (Karolinska sleepiness scale and EEG markers of sleepiness with the Somfit device) before and after meals.\n\nThe hypothesis is that increased sleepiness would favor food intake of high GI foods, which would worsen sleepiness in all 3 groups, with a more pronounced effect in NT1. Compared to IH patients and controls, NT1 patients may present more snacking of high GI foods, especially at night if sleep is disrupted, and this would be correlated with body composition.\n\nThe findings will help to better understand the mechanisms of obesity in narcolepsy and may lay the ground for the development of new therapeutic strategies in disorders of hypersomnolence, targeting dietary behaviors.",[61,26],[119,26,120,121,122],"Narcolepsy type 1","Obesity","Food intake","Disrupted nighttime sleep","2026-06-01",{"date":125,"type":38},"2026-06-03",{"date":127,"type":38},"2024-10-16",{"date":129,"type":20},"2027-07-16",{"name":131,"class":132},"Hospices Civils de Lyon","OTHER",2,{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":145,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":158,"leadSponsor":160,"locationsCount":73},"100640164","phase-3-a-study-evaluating-the-efficacy-and-safety-of-xywav-expanded-dosing-vs-placebo-in-participants-with-narcolepsy-or-ih-100640164","NCT07625280","A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH","A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized-withdrawal Study to Evaluate the Efficacy and Safety of Expanded Dosing Regimens for Xywav in Adult Participants With Narcolepsy or Idiopathic Hypersomnia","XYRISE","Inclusion Criteria:\n\n1. Has a primary diagnosis of IH or narcolepsy Type 1 or Type 2 (NT1 or NT2)\n2. If not currently treated with oxybate, has clinically significant symptoms of excessive daytime sleepiness (EDS) with an Epworth Sleepiness Scale (ESS) score \\> 11 at screening.\n3. If currently treated with oxybate, must have documented improvement of EDS with oxybate treatment per the investigator's clinical judgement.\n4. If currently treated with oxybate, has been taking the same stable dosing regimen at a total nightly dosage of 3 g to 9 g (inclusive) for at least 2 months at screening.\n5. If previously treated with (and not currently taking) oxybate, must have been off oxybate treatment for at least 2 weeks prior to screening. Must not have previously discontinued oxybate due to reasons related to intolerability, safety, or lack of efficacy.\n6. If currently treated with anticataplectics (NT1 only) and\u002For alerting agents, has been taking the same dosage for at least 1 month prior to screening and has no current plans to adjust the dosage during the study period.\n7. If currently treated with nicotine replacement therapy, has been taking the same dosage for at least 1 month prior to screening and has no current plans to adjust the dosage during the study period.\n8. Adequate contraceptive precautions\n\nExclusion criteria:\n\n1. Shows evidence of a previous untreated or inadequately treated sleep disorder considered by the investigator to negatively impact the conduct of the study, including sleep-disordered breathing, parasomnias, circadian rhythm sleep disorders, or restless legs syndrome determined by a previous sleep-laboratory diagnosis or interview utilizing modules of the Diagnostic Interview for Sleep Patterns and Disorders.\n2. Has succinic semi-aldehyde dehydrogenase deficiency by medical history.\n3. Has uncontrolled hypothyroidism as determined by central clinical laboratory test results.\n4. Has a current seizure disorder.\n5. Has a history of head trauma associated with loss of consciousness in the past 5 years\n6. Has a history or presence of bipolar disorder, bipolar-related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders\n7. Has a history or presence of any unstable or clinically significant medical condition, behavioral or psychiatric disorder, or history or presence of another neurologic disorder or surgical history that might affect the participant's safety and\u002For interfere with the conduct of the study, in the opinion of the investigator.\n8. Has any other significant disease or disorder that, in the opinion of the investigator, may either put the participant, other participants, or study staff at risk because of participation in the study, may influence the result of the study, or may affect the participant's safety or ability to take part in the study.\n9. Any past or current medical conditions or experience that, in the investigator's clinical judgment, would preclude treatment with a once-nightly dose \\> 6 g up to 7.5 g dose or twice-nightly regimen with a total nightly dosage \\> 9 g up to 12 g (divided into 2 doses).\n10. Has any severe drug allergy or a history of allergic or severe adverse reactions or intolerance to Xyrem, Xywav, Gamma-hydroxybutyrate (GHB), or any components of the dosage forms.\n11. Has recently taken, is taking, or plans to take any of the following:\n\n    1. A substance or medication contraindicated with Xywav use\n    2. A medication with a known drug-drug interaction with Xywav\n    3. Medications known to have clinically significant CNS sedating effects:\n    4. Other medications, natural health products, or substances from which the participant experiences clinically significant sedation\n12. Has recently taken, is taking, or plans to take an Orexin 2 receptor (OX2R) agonist during the study.\n13. Has tobacco-use disorder or uses vaping products that impact sleep\n14. Has excessive caffeine consumption that may impact sleep\n15. Has clinically significant abnormal laboratory values\n16. Has an occupation that requires nighttime or variable shift work\n17. Has plans for travel across more than 3 time zones during the study","75 Years",{"count":144,"type":20},108,[23],"The purpose of this study is to evaluate the efficacy and safety of expanded Xywav dosing regimens in adult participants with narcolepsy or idiopathic hypersomnia (IH).",[148,26],"Narcolepsy",[150,61,151,62,152,89],"Xywav","NT1","NT2","NOT_YET_RECRUITING","2026-05-27",{"date":156,"type":38},"2026-06-04",{"date":35,"type":20},{"date":159,"type":20},"2028-01-06",{"name":161,"class":45},"Jazz Pharmaceuticals",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":111,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":171,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":184},"100503579","phase-4-low-sodium-oxybate-in-patients-with-idiopathic-hypersomnia-100503579","NCT05837091","Low Sodium Oxybate in Patients With Idiopathic Hypersomnia","Impact of Low Sodium Oxybate on Total Sleep Time in Patients With Idiopathic Hypersomnia","Inclusion Criteria:\n\n1. Primary diagnosis of IH, according to ICSD-3 criteria (does not require MSLT)\n2. Subjects aged 18 - 65 years\n3. BMI between 18 and 35 kg\u002Fm2\n4. Self-reported sleep duration ≥ 9 hours most days including daytime naps\u002Fsleep based upon at least 10\u002F14 days of completed sleep diary entries\n5. Epworth Sleepiness Scale (ESS) ≥ 10 (required at pre-screening visit only)\n6. Recommended LSO by a clinical sleep specialist as part of routine medical care. The clinical sleep specialist will be responsible for titrating LSO according to standard of care.\n7. Subject must be willing to postpone LSO therapy until all baseline assessments completed\n8. If treated with wake promoting agents, traditional stimulants and\u002For antidepressant(s), a stable dose and regimen will be required for at least 2 months before study entry and throughout the main study\n9. Have used a medically acceptable method of contraception for at least 2 full menstrual cycles before participating in this study and consent to use a medically acceptable method of contraception from the first dose of study drug, throughout the entire study period, and for 30 days after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Succinic semialdehyde dehydrogenase deficiency, porphyria\n2. Other central nervous system diseases: neurodegenerative diseases, , seizure disorders or history of head trauma associated with loss of consciousness\n3. Lifetime history of suicide attempt or suicidal ideation in the past six months, including answer to question #9 on PHQ-9 ≥1; PHQ-9 total score \\> 10; prior history of psychotic episodes; active major depressive disorder\n4. Change to psychiatric medication(s)\u002Fstimulant(s) within last 3 months\n5. History of chronic alcohol or drug abuse within the prior 12 months\n6. Malignant neoplastic disease requiring therapy within the prior 12 months\n7. Heart failure, severe hypertension or other cardiovascular disease compromising the patient's well-being or ability to participate in this study\n8. Renal or hepatic impairment\n9. Compromised respiratory function (e.g., history of COPD, pulmonary hypertension, and\u002For poorly controlled asthma)\n10. Diagnosis of sleep-related breathing disorders (AHI ≥ 15 events\u002Fh using 4 % AHI) or high suspicion for sleep disordered breathing\n11. Any sleep apnea treatment (e.g., Positive Airway Pressure (PAP) therapy, oral appliance therapy, etc.)\n12. No regular sleep at night: shift work or other continuous, non-disease-related life conditions\n13. Participation in another study of an investigational drug within the 28 days prior to Screening visit or currently\n14. Pregnant and\u002For breast-feeding\n15. Ear jewelry and\u002For piercings that subject not willing to\u002Funable to remove\n16. Use of device\u002Fimplant that may interfere with the study devices\u002Fprocedures (e.g., vagal nerve stimulator)\n17. Smoke and\u002For use of smokeless tobacco products\n18. Subjects who, in the opinion of the investigator(s), may not be suitable for the study",{"count":170,"type":20},30,[172],"PHASE4","Low sodium oxybate has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic hypersomnia. In this study, the researchers want to learn how low sodium oxybate impacts ability of people diagnosed with idiopathic hypersomnia to sleep for long periods of time. In addition, this study will use novel tools to determine when an individual is awake or asleep.",[26],"2026-05-08",{"date":177,"type":38},"2026-05-12",{"date":179,"type":38},"2024-02-14",{"date":181,"type":20},"2027-06",{"name":183,"class":132},"Mayo Clinic",4,{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":111,"enrollmentInfo":193,"targetDuration":4,"studyType":21,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":206},"100573929","phase-2-a-study-of-orx750-in-participants-with-narcolepsy-and-idiopathic-hypersomnia-100573929","NCT06752668","A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia","A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ORX750 in Subjects With Narcolepsy and Idiopathic Hypersomnia (CRYSTAL-1)","CRYSTAL-1","Inclusion Criteria:\n\n* 18-65 years of age\n* BMI ≥17 and ≤37 kg\u002Fm2\n* Meets the diagnostic criteria of Narcolepsy Type 1 (NT1), Type 2 (NT2) or Idiopathic Hypersomnia (IH) according to ICSD-3-TR criteria\n* Is willing and able to discontinue all medications used for the treatment of narcolepsy or idiopathic hypersomnia\n* Is willing and able to adhere to additional protocol requirements\n\nExclusion Criteria:\n\n* A medical disorder other than NT1, NT2, or IH that is associated with excessive daytime sleepiness (EDS).\n* Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease",{"count":19,"type":20},[58],"Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), and Idiopathic Hypersomnia (IH) are rare conditions that make people feel very sleepy during the day (often referred to as excessive daytime sleepiness \\[EDS\\]). People living with these conditions might find it hard to stay alert and pay attention when they are at school, working, driving, or performing other daily activities.\n\nWhile all conditions result in feeling sleepy, there are some differences in other common symptoms:\n\n* NT1: People with NT1 often feel very tired during the day and experience cataplexy. Cataplexy is a sudden loss of muscle strength, which can cause someone to collapse or lose control of their muscles for a short time. This is often triggered by strong emotions, such as laughter or surprise. They may also have trouble sleeping well at night.\n* NT2: People with NT2 feel sleepy during the day, just like NT1, but they do not have cataplexy.\n* IH: People with IH feel tired during the day, even after sleeping a lot at night. They may sleep for long periods, take long naps, and find it hard to wake up.\n\nOrexin is a protein in the brain that helps coordinate a system that plays an important role in helping people to stay awake during the daytime. Cleminorexton (also known as ORX750) is designed to mimic the action of orexin. The purpose of this study is to see how safe and tolerable ORX750 is in NT1, NT2, and IH, and learn about what the drug does to the body. Another goal of the study is to see if ORX750 can help people with NT1, NT2, and IH feel less sleepy and make other symptoms better.",[61,62,26],"2026-04-22",{"date":199,"type":38},"2026-04-27",{"date":201,"type":38},"2024-12-23",{"date":203,"type":20},"2026-12",{"name":205,"class":45},"Centessa Pharmaceuticals (UK) Limited",37,{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":111,"enrollmentInfo":214,"targetDuration":4,"studyType":21,"phases":216,"briefSummary":217,"conditions":218,"keywords":219,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":230},"100600375","phase-2-a-long-term-extension-study-of-orx750-in-participants-with-narcolepsy-and-idiopathic-hypersomnia-100600375","NCT07096674","A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia","A Phase 2, Long-term Extension Study of the Safety and Efficacy of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia Who Completed a Sponsored ORX750 Clinical Trial","Inclusion Criteria:\n\n* Diagnosis of narcolepsy (NT1 or NT2) or IH who was eligible for and completed the full treatment period in the eligible parent study ORX750-0201 (CRYSTAL-1)\n* Is willing and able to adhere to additional protocol requirements\n\nExclusion Criteria:\n\n* Development of any new disease\u002Fdisorder that in the opinion of the investigator would make the participant unable to continue the study\n* Unable to refrain from excluded medications, including those used for treatment of narcolepsy or idiopathic hypersomnia",{"count":215,"type":20},90,[58],"This study is a long-term extension (LTE) of the parent Study ORX750 0201, and will provide long-term open-label safety, tolerability, and efficacy of ORX750 in participants with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH).",[61,62,26],[151,152,89,148,61,62,26,220,221],"Excessive Daytime Sleepiness","Orexin Receptor 2 agonist","2026-04-15",{"date":224,"type":38},"2026-04-16",{"date":226,"type":38},"2025-08-12",{"date":228,"type":20},"2026-04-30",{"name":205,"class":45},24,{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":82,"enrollmentInfo":238,"targetDuration":4,"studyType":21,"phases":240,"briefSummary":241,"conditions":242,"keywords":243,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":253},"100578498","phase-2-a-study-of-tak-360-in-adults-with-idiopathic-hypersomnia-100578498","NCT06812078","A Study of TAK-360 in Adults With Idiopathic Hypersomnia","A Dose-Finding, Adaptive, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Idiopathic Hypersomnia (IH)","Key Inclusion Criteria:\n\n1. The participant weighs greater than or equal to (≥) 40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg\u002Fm\\^2) \\[inclusive\\].\n2. The participant has a documented, current diagnosis of IH.\n\nKey Exclusion Criteria:\n\n1. The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) \\[other than IH\\].\n2. The participant has medically significant thyroid disease.\n3. The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ \\[such as basal cell carcinoma\\] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor.)\n4. The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus antibody (at screening), human immunodeficiency virus (HIV) antibody\u002Fantigen (at screening).\n5. The participant has a clinically significant history of head injury or head trauma.\n6. The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).\n7. The participant has a history of cerebral ischemia, transient ischemic attack (less than \\[\\\u003C\\]5 years from screening), intracranial aneurysm, or arteriovenous malformation.",{"count":239,"type":20},96,[58],"Idiopathic Hypersomnia (IH) is a condition where people feel extremely sleepy during the day, especially in the morning, even if they sleep a lot at night. They may have trouble waking up in the morning, no matter how much they sleep (sometimes more than 11 hours per day), and they can't help feeling tired, even after taking daytime naps. Because of this sleepiness, they may have trouble focusing, thinking clearly, or keeping up with daily activities. They may also have symptoms like dizziness or feeling lightheaded. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake.\n\nThe main aim of this study is to learn how safe TAK-360 is and how well adults with IH tolerate it. Researchers also want to find out if TAK-360 can help people with IH stay awake and how much TAK-360 is needed to do that.\n\nParticipants will be randomly (by chance, like drawing names from a hat) chosen to receive either TAK-360 or a placebo. The placebo looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.",[26],[26,244],"TAK-360","2026-03-23",{"date":247,"type":38},"2026-03-24",{"date":249,"type":38},"2025-02-07",{"date":251,"type":20},"2026-07-16",{"name":72,"class":45},29,{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":82,"enrollmentInfo":261,"targetDuration":4,"studyType":21,"phases":263,"briefSummary":264,"conditions":265,"keywords":266,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":275},"100575084","phase-2-a-long-term-study-of-alks-2680-in-subjects-with-narcolepsy-and-idiopathic-hypersomnia-100575084","NCT06767683","A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia","An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Subjects With Narcolepsy Type 1 and Type 2 and Idiopathic Hypersomnia","Inclusion Criteria:\n\n* Was eligible for and has completed end of treatment visit of ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible studies are ALKS 2680-201 (Vibrance-1), ALKS 2680-202 (Vibrance-2) and ALKS 2680-203 (Vibrance-3)\n* Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy symptoms, as applicable, for 5 half-lives prior to Day 1 (for re-entry subjects), and for the duration of study (for all subjects)\n\nExclusion Criteria:\n\n* Developed a new clinically significant health condition, ECG or laboratory abnormality, in the opinion of the Investigator or Sponsor, may impact the subject's participation in the study\n* Is currently pregnant, breastfeeding, or planning to become pregnant during the study\n* Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening",{"count":262,"type":20},256,[58,23],"The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.",[61,62,26],[148,61,62,151,152,92,90,91,31,89,26],"2026-03-03",{"date":269,"type":38},"2026-03-04",{"date":271,"type":38},"2025-01-27",{"date":273,"type":20},"2028-06",{"name":101,"class":45},46,{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":21,"phases":285,"briefSummary":286,"conditions":287,"keywords":290,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":73},"100593422","a-novel-approach-to-manage-symptoms-of-narcolepsy-and-idiopathic-hypersomnia-100593422","NCT07006233","A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia","A Novel Dietary Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia","COMPANION","Inclusion Criteria:\n\n* Evidence (from multiple sleep latency test, 24-hour polysomnography, or actigraphy) of diagnosis of narcolepsy type 1, narcolepsy type 2 or idiopathic hypersomnia that meets ICSD-3 criteria.\n* For the NT1 subtype, patients must have been screened positive for the HLA DQB10602 genotype.\n* Body mass index \\>18.5 kg\u002Fm2\n* 18 years or over\n* Be willing to be involved in dietary change that may include animal protein and fat.\n* Be willing to monitor ketones via finger-prick and urinary dipstick.\n* Habitual diet is a standard diet consuming a moderate or high carbohydrate level (defined for the study as above 130g carbohydrate\u002Fday).\n* Willingness to provide informed consent and willingness to participate and comply with the study requirements.\n* Access to a computer, laptop, tablet, or smartphone and stable internet access.\n* Proficient comprehension of English language (able to independently read information sheet) and availability of a support person during consultations if English comprehension is challenged.\n\nExclusion Criteria:\n\n* Body mass index \\\u003C18.5 kg\u002Fm2, history of an eating disorder with an EDE-Q score greater than 3.\n* Participants who have sustained significant weight loss in the last 3 months (\\>5% change in total body weight).\n* Previous bariatric surgery or current prescription of weight loss medication.\n* Diagnosis of unstable psychiatric disorders (excluding anxiety or depression).\n* Cognitive impairment that limits ability to understand the study requirements or provide informed consent.\n* Physical impairment that limits ability to meet the study requirements.\n* Non-English speaking and inability to read the Participant Information Sheet.\n* No access to stable internet and device on which to participate in telehealth consultations and complete study questionnaires.\n* Person lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study period.\n* Habitual diet is currently low carbohydrate\u002Fketogenic (defined for the study as \\\u003C130g carbohydrate\u002Fday based on screening 24 food hour recall).\n* Habitual diet excludes animal products (e.g. Vegan diet).\n* Laboratory parameters that may indicate alternate catalyst for hypersomnolence in the opinion of the study physician, including abnormal: full blood count, thyroid function, Epstein-Barr Virus, erythrocyte sedimentation rate, cortisol, antinuclear antibodies, extractable nuclear antigen test, positive rheumatoid factor, Antistreptolysin O positive, Iron studies or multiple biochemistry panel.\n* Participants who have changed their medication prescription or dose within the preceding 4 weeks.\n* Participants with inherited metabolic disorders, prior history of hypoglycaemia or insulinoma\n* Participants with insulin dependent Type 1 or Type 2 diabetics prescribed insulin which may interfere with the participant's ability to meet the study requirements.\n* Participants with uncontrolled medical conditions or patients with significant medical co-morbidities who in the opinion of the study physician, would be at risk of adverse health consequences due to the study intervention (e.g. poorly controlled type 2 diabetic patients who are not prescribed insulin)\n* Current cancer diagnosis (excluding skin cancers or benign cancers)\n* Current active enrolment in a pharmaceutical or intervention based clinical trial or participant who may have received an investigational new drug within the last 12 weeks.",{"count":170,"type":20},[115],"The aim of this project is to learn about how a change in diet will affect sleepiness, quality of life and metabolic health in people living with narcolepsy and idiopathic hypersomnia. The dietary changes we will be testing are well researched and safe in a wide range of patient groups (such as in obesity, type one and two diabetes, cancer and dysfunction related to the nervous system) but has not been researched in conditions of hypersomnolence such as narcolepsy and idiopathic hypersomnia. It is important to test adjunct therapies and lifestyle changes such as dietary interventions to ensure that people living with hypersomnolence have a range of options in addition to medications, to improve their health.\n\nIf effective, this project will be tested in more people and may become a part of routine patient care. These dietary approaches have been shown to improve health and quality of life in people living with chronic pain, neurological conditions such as epilepsy and have been shown to be safe in these populations as well as people living with type one diabetes. This is a new area of research for people living with hypersomnolence.",[26,288,289],"Narcolepsy Type 1 (NT 1)","Narcolepsy Type 2 (NT2)",[291,292,293,294,295,30,296,297,298,299,300],"keto diet","ketogenic","keto","whole food diet","narcolepsy","low carb","hypersomnolence","diet","dietary intervention","diet intervention","2025-08-20",{"date":303,"type":38},"2025-08-27",{"date":305,"type":38},"2025-06-23",{"date":307,"type":20},"2026-06",{"name":309,"class":132},"University of Sydney",{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":317,"enrollmentInfo":318,"targetDuration":4,"studyType":21,"phases":320,"briefSummary":321,"conditions":322,"keywords":323,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":73},"100535495","phase-2-a-chronobiological-treatment-combining-evening-melatonin-and-morning-light-therapy-in-idiopathic-hypersomnia-a-prospective-double-bind-randomized-placebo-controlled--trial-100535495","NCT06252571","a Chronobiological Treatment Combining Evening Melatonin and Morning Light Therapy in Idiopathic Hypersomnia: a Prospective, Double Bind, Randomized, Placebo-controlled -Trial","HyperChrono","Inclusion criteria:\n\n* Male or female patient\n* Age ≥ 18 and ≤ 40 years at signature of informed consent form\n* Diagnosed with Idiopathic hypersomnia in a reference\u002Fcompetence center of hypersomnia rare disease network according to ICSD-3 criteria (International classification of sleep disorders) with symptoms lasting since \\>3 months and a total sleep time ≥11hours objectified with a 24h continuous polysomnography realized during the last 12 months\n* Patient with stable medication in the month preceding inclusion and throughout the 10 weeks of participation to the study (except for drugs excluding participation. See list below).\n* Patient able to be compliant with therapy during the required time and at the set schedule.\n* For female patient: effective efficient contraception during the month preceding the inclusion and all along the study\n* Patient who have given written informed consent and are able to understand the objectives and risks associated to the research.\n* Patient affiliated to a social security insurance\n\nExclusion criteria:\n\n1. Criteria related to the underlying disorder (other forms of hypersomnia or sleep disorder)\n\n   * Other primary or secondary hypersomnia (narcolepsy, Kleine-Levin syndrome, post-traumatic hypersomnia, hypersomnia due to medication or substance abuse…)\n   * Other intrinsic sleep disorder according to ICSD-3 criteria (sleep apnea syndrome, restless legs syndrome, insomnia)\n2. Criteria related to pathologies associated with particular risks or consumption of substances that may affect sleep or alertness:\n\n   * Significant psychiatric comorbidities (current severe depressive episode based on the DSM-V criteria, risk of suicide, schizophrenia, bipolar disorder).\n   * Known systemic or severe acute disease (auto-immune diseases…)\n   * Substance \u002F alcohol \u002Fcigarette dependence\n   * Consumption of excessive amounts of caffeine, defined as greater than 600 mg of caffeine of coffee, tea, cola, energy drinks, or other caffeinated beverages per day (1 cup of coffee is approximately 120 mg)\n3. Criteria related to circadian rhythms disturbances\n\n   * Recent transmeridian travel (\\> 2 time zones) within the month before the start of the study\n   * History of shift\u002Fnight work reported within the 6 months preceding the study\n   * Irregular sleep habits (more than 2 hours of delay or advance in bedtime ≥ 3 nights over a week)\n   * Circadian sleep-wake rhythm disorders according to ICSD-3 criteria (advanced or delayed sleep phase syndrome, …)\n4. criteria related to medications (within 1 month prior to study)\n\n   * Sleep promoting drugs (benzodiazepines, z-drugs, sodium oxybate, antihistaminics…)\n   * Wake promoting-drugs (modafinil, pitolisant, methylphenidate, solriamfétol chlorhydrate)\n   * Psychotropics and drugs inducing level 3 sleepiness according to the ANSM (French National Agency for Medicines and Health Products Safety) gradation.\n   * beta-blockers\n   * regular anti-inflammatory drug intake\n   * Exogenous melatonin and\u002For serotonin and or tryptohane (as a drug or a dietary supplement)\n5. Criteria related to relative contra-indications to light therapy\n\n   * Medical history of ophthalmologic diseases causing visual impairment: retinopathy, age-related macular degeneration, macular hole, epiretinal membrane; cataract; optic neuropathy.\n   * On-going medication with a photosensibilizing drug\n   * Photosensitive epilepsia or migraine\n6. Criteria relative to exogenous melatonin administration\n\n   * Prior intolerance to cellulose or exogenous melatonin\n   * Drugs metabolized by CYP1A2 intake within 1 month prior to study: antivitamin K, fluvoxamine, cimetidine, carbamazepine, rifampicin…\n7. Criteria relative to relative contraindications of e-celsius capsules\n\n   * Patient weighting less than 40 kg\n   * Medical history of motility disorders of the gastrointestinal tract and intestinal disorders that can lead to obstruction of the digestive tract, including diverticula, Crohn disease, surgical procedures in the gastrointestinal tract\n   * Known swallowing disorders\n   * In presence of a pacemaker or electro-medical implant.\n   * Patient who has to undergo strong electromagnetic field during the period of use of the system (MRI)\n8. Criteria relative to regulation:\n\n   * Pregnancy, breastfeeding.\n   * Participation in another interventional clinical trial with an exclusion period\n   * Patient with difficulty to read or understand French, or inability to understand the delivered information\n   * Patient in emergency situation\n   * Patient in life-threatening situation\n   * Patient under justice safeguard\n   * Patient under guardianship or limited guardianship\n   * Patient unwilling to refrain from driving and\u002For operating dangerous or hazardous machinery during times of heightened sleepiness or fatigue due to the medication","40 Years",{"count":319,"type":20},72,[58],"Idiopathic hypersomnia (IH) is a chronic disabling disorder characterized by excessive daytime sleepiness (EDS), prolonged nighttime sleep and sleep inertia. IH is a rare disorder, estimated around 0.05%, yet its true prevalence remains unknown. Disease onset occurs most often during young adulthood and is accompanied by severe social, professional and economic impairments, resulting in risk of accident and a loss in patient's quality of life. There are no ANSM (or FDA-) approved treatments for IH symptoms.\n\nIH shares common features with delayed sleep-wake phase disorder (DSWPD) which is a chronic circadian rhythm disorder which occurs as in IH during young adulthood. The combination of evening melatonin and morning bright light therapy is the most effective validated chronotherapy in DSWPD.Moreover, bright light therapy has direct effects and is known to increase daytime alertness and to improve mood.\n\nMelatonin is empirically used in routine clinical practice in patients with IH and French and European recommendations mention melatonin as a possible treatment of sleep inertia in IH.\n\n. Our goal is to bring a proof of concept of a safe therapeutic practice for IH combining exogenous melatonin and bright light therapy in",[26],[324,325,326,90,327],"hypersomnia","light","melatonin","chronobiotherapy","2025-08-04",{"date":330,"type":38},"2025-08-08",{"date":332,"type":38},"2024-09-07",{"date":334,"type":20},"2027-09-07",{"name":336,"class":132},"University Hospital, Strasbourg, France",{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":21,"phases":346,"briefSummary":347,"conditions":348,"keywords":4,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":4},"100598883","phase-4-effect-of-low-sodium-oxybate-lxb-on-autonomic-symptom-burden-in-idiopathic-hypersomnia-patients-with-postural-tachycardia-syndrome-100598883","NCT07077278","Effect of Low Sodium Oxybate (LXB) on Autonomic Symptom Burden in Idiopathic Hypersomnia Patients With Postural Tachycardia Syndrome","Effect of Low Sodium Oxybate (LXB) on Autonomic Symptom Burden in Idiopathic Hypersomnia Patients With Postural Tachycardia Syndrome: a Placebo-controlled, Double-blind, Randomized Withdrawal Study","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. English speaking and capable of signing the informed consent form and comply with the protocol requirements\n3. Diagnosis of IH based on ICSD-3 criteria\n4. Diagnosis of POTS based on the 2011 Consensus Criteria\n5. Oxybate naïve. Participants on daytime alerting medications at baseline can remain on these medications for the duration of the study, provided doses remain stable for the duration of the study. This rule also applies to medications prescribed for the treatment of POTS. All medications known to affect cardiovascular function will be held for the appropriate time periods prior to active stand testing so as not to influence results.\n6. COMPASS 31 ≥ 40 at the screening visit\n7. Agree to use contraceptives consistent with local regulations regarding the methods of contraception for those participating in clinical trials\n\nExclusion Criteria:\n\n1. Hypersomnia due to another medical, behavioral, sleep, or psychiatric disorder\n2. Evidence of untreated or inadequately treated sleep disordered breathing, defined as AHI ≥ 10\n3. History of bipolar or psychotic disorders, major depressive episode, or current suicidal risk\n4. Pregnant or lactating or intends to become pregnant during the study\n5. History of or currently being treated for clinically significant ongoing cardiac arrythmia, heart failure, myocarditis, pulmonary embolism requiring anticoagulation, pulmonary fibrosis or other pulmonary diagnosis that in the investigator's opinion may contribute to symptoms of POTS\n6. Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection or positive SARS-CoV-2 PCR test at screening\n7. A medical condition that could confound the results of the study or put the participant at undue risk in the investigator's judgment\n8. Intends to have surgery or procedures requiring anesthesia or conscious sedation during the study\n9. Currently participating in another interventional clinical study\n10. Unwilling to remain on a stable regimen of medications during the study\n11. Use of or planned use of intravenous saline infusions during the study",{"count":345,"type":20},25,[172],"The investigators hope to learn if low sodium oxybate (LXB) is an effective treatment for symptoms of idiopathic hypersomnia (IH) and postural tachycardia syndrome (POTS). Previous research has shown that patients with IH also report having symptoms associated with POTS. The researchers have observed that in patients with both IH and POTS, when patients' sleep quality improves, so do their POTS symptoms. The goal of this study is to test this in a controlled way by using LXB as a treatment for both IH and POTS in patients that have been diagnosed with both conditions.",[26,349],"POTS - Postural Orthostatic Tachycardia Syndrome","2025-07-22",{"date":352,"type":38},"2025-07-25",{"date":354,"type":20},"2025-10-01",{"date":356,"type":20},"2027-09",{"name":358,"class":132},"Stanford University",{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":110,"sex":16,"minAge":17,"maxAge":111,"enrollmentInfo":366,"targetDuration":4,"studyType":21,"phases":368,"briefSummary":370,"conditions":371,"keywords":408,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":73},"100565622","phase-1-evaluating-the-efficacy-and-safety-of-prosomnia-sleep-therapy-in-patients-with-sleep-deprivation-and-chronic-insomnia-100565622","NCT06644573","Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia","PSHW","By adhering to the following criteria, the study aims to select a population that can safely undergo the PROSOMNIA Sleep therapy and for whom the therapy is most likely to be beneficial, ensuring the reliability and validity of the study outcomes.\n\nINCLUSION CRITERIA:\n\n1. Age Range: 18-65 years of age Reason: This age range includes adults who are most likely to benefit from the PROSOMNIA Sleep therapy and who can provide informed consent. It also excludes children and older adults who may have different physiological responses or additional health risks.\n2. Diagnosed or Undiagnosed Chronic Insomnia:\n\n   Reason: Included subjects have a consistent pattern of sleep disturbances that PROSOMNIA Sleep Therapy aims to treat.\n3. Diagnosed or Undiagnosed Sleep Deprivation:\n\n   Reason: Includes individuals who are not getting enough sleep quantity, which is a key condition that the PROSOMNIA Sleep Therapy aims to address.\n4. Diagnosed or Undiagnosed REM Sleep Inconsistencies:\n\n   Reason: Includes individuals who are not getting enough sleep quality and those with specific REM sleep phase issues that the PROSOMNIA Sleep Therapy is designed to improve.\n5. Failure to Respond to Conventional Sleep Treatments:\n\n   Reason: Focuses on subjects who have not found relief from existing sleep therapies, ensuring that the study population represents those in need of alternative solutions.\n6. Ability to Provide Informed Consent:\n\nReason: Ensures that participants understand the study and agree to participate voluntarily.\n\nEXCLUSION CRITERIA:\n\n1. Severe Obesity (BMI \\> 40):\n\n   Reason: Severe obesity can increase the risk of complications with anesthesia and may affect sleep patterns in ways that could confound study results.\n2. Cardiovascular Conditions:\n\n   Reason: Patients with significant heart conditions are at higher risk for complications during anesthesia.\n3. Neurological Disorders:\n\n   Reason: These diagnosed conditions and medications such as epilepsy could interfere with sleep patterns and responses to sleep therapy.\n4. Other Health Conditions Contraindicating Anesthesia:\n\n   Reason: Includes any condition that would make the use of anesthesia unsafe.\n5. Greater than ASA II Status:\n\n   Reason: The American Society of Anesthesiologists (ASA) physical status classification system classifies patients based on their pre-anesthesia medical conditions. Excluding those above ASA II ensures that only patients with mild systemic disease are included, to minimize risks.\n6. Current Use of Prohibited Medications:\n\n   Reason: Medications that could interfere with the combined use of anesthesia including, but not limited to sedatives and hypnotics; such as benzodiazepines, Z-drugs and barbiturates.\n7. Pregnancy or Breastfeeding:\n\nReason: Ensures the safety of the fetus or infant, as the effects of the PROSOMNIA Sleep therapy on pregnancy or lactation are unknown.",{"count":367,"type":20},100,[369],"PHASE1","This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders. Chronic insomnia, characterized by difficulty falling or staying asleep, significantly affects patients and quality of life, mood, and cognitive function. REM sleep disorders, in which the body struggles to enter or maintain restful REM sleep, can worsen these issues. The trial introduces a novel therapy using anesthesia-induced sleep, targeting sleep homeostasis and improving sleep architecture.\n\nObjectives: The primary goals of the trial are to determine:\n\n1. Whether PROSOMNIA Sleep Therapy increases the quality of REM sleep.\n2. Whether PSTx increases the duration of REM and\u002For NREM sleep.\n3. Whether PSTx decreases the time it takes participants to fall asleep (sleep onset latency).\n\nParticipants will receive ONE (1) PROSOMNIA Sleep Therapy session lasting between 60-120 minutes. Each session uses Diprivan\u002FPropofol to induce sleep, and is monitored via an EEG to ensure proper sleep stages, particularly REM sleep.\n\nParticipant Criteria:\n\nInclusion: Adults aged 18-65 with diagnosed or undiagnosed chronic insomnia or sleep deprivation.\n\nExclusion: Patients with severe obesity, significant cardiovascular, neurological, or psychiatric conditions, or those with an ASA status above II.\n\nStudy Design: This trial is non-randomized, single-arm and open-label, with all participants receiving the PSTx. The trial does not include a comparison group, as the focus is on evaluating the immediate, direct effects of the therapy.\n\nParticipants will undergo continuous EEG monitoring during therapy sessions, allowing researchers to track brain activity and sleep stages in real-time. This method ensures that sleep cycles, particularly REM sleep, are optimized for therapeutic benefit.\n\nTherapy Methodology:\n\nPROSOMNIA Sleep Therapy leverages anesthesia to mimic natural sleep patterns and enhance the efficiency of REM sleep. Diprivan\u002FPropofol is used to induce REM sleep, while EEG monitoring tracks and maintains proper sleep architecture throughout the session. The therapy promotes the clearance of adenosine, a compound that builds up during wakefulness and drives the need for sleep. Adenosine is cleared during REM sleep, reducing sleep pressure and improving cognitive function.\n\nOutcome Measures:\n\nPrimary Outcomes: Researchers will measure the increase in REM sleep duration, improvement in sleep quality (via self-reported questionnaires), and a reduction in sleep onset latency.\n\nSecondary Outcomes: These include changes in mood, cognitive function, and blood serum uric acid levels. Patient-reported outcomes will also be tracked through tools like the PROSOMNIA Sleep Quiz, which is specifically designed for PSTx.\n\nSignificance: Chronic insomnia and REM sleep disorders affect millions globally, leading to cognitive impairment, mood disturbances, and poor overall health. Traditional treatments, including pharmacological approaches and Cognitive Behavioral Therapy for Insomnia (CBT-I), often provide suboptimal results for many individuals. PSTx offers a novel, therapeutic approach to restoring sleep balance and enhancing the overall quality of sleep, particularly for those who have not responded to conventional treatments.\n\nStudy Process:\n\nRecruitment and Baseline Assessments: Participants undergo a comprehensive sleep assessment, including sleep questionnaires and polysomnography, to establish a baseline for sleep quality and duration. Blood serum uric acid levels will also be measured to track any biochemical changes due to therapy.\n\nTherapy Sessions: Only one (1) PROSOMNIA Sleep Therapy session will be administered, with the session lasting between 60-120 minutes. Diprivan\u002FPropofol is used to induce sleep, and EEG will monitor brain activity to ensure the proper balance of sleep stages.\n\nPost-Therapy Follow-up: Follow-up assessments will occur at 24 hours, 7 days, and 30 days post-treatment. Researchers will analyze the therapy effects on REM sleep, mood, cognitive function, and other health indicators.\n\nPotential Implications: If successful, this trial could revolutionize how we treat sleep disorders by targeting the underlying mechanisms of sleep pressure and REM sleep disruption. PROSOMNIA Sleep Therapy may offer a safe, effective, and immediate alternative for patients who have exhausted other treatment options.\n\nKey Concepts:\n\nHomeostatic sleep drive, (Process S), caused by adenosine buildup during wakefulness, is disrupted by chronic insomnia. This impacts cognitive function health and recovery. Anesthesia-induced REM sleep via PSTx helps regulate this homeostatic sleep stage, offering deeper and more restorative sleep compared to other sleep therapies. The study uses statistical methods like ANOVA and Chi-square to measure outcomes.",[372,373,374,375,376,377,378,379,380,381,382,383,26,384,385,386,387,388,389,390,391,392,393,394,395,396,397,398,399,400,401,402,403,404,405,406,407],"Chronic Insomnia","Sleep Deprivation","REM Behavior Disorder","REM Sleep Behavior Disorder","REM Sleep Measurement","Insomnia","Insomnia Related to Specified Disorder","Insomnia Due to Other Mental Disorder","Insomnia Comorbid to Psychiatric Disorder","Insomnia Due to Anxiety and Fear","Insomnia Related to Another Mental Condition","Insomnia Disorders","Sleep Disorders, Circadian Rhythm","Post Trauma Nightmares","PTSD - Post Traumatic Stress Disorder","Sleep Quality","Anesthesia","Anxiety","Depression","Mental Health","Alzheimer Disease or Associated Disorder","Parkinsons","Circadian Rhythm","Circadian Dysregulation","PTSD","Post-Traumatic","Post-Traumatic Stress Disorder Complex","Military Combat Stress Reaction","Sleep","Military Activity","Veterans","Shift Work Sleep Disorder","Menopause Related Conditions","Pain","Cancer Pain","Athletes",[409,410,411,412,413,414,415,416,417,418,419,420,421,422,423,424,425,426,377,373,89,26,427,396,391,389,390],"SLEEP","PROSOMNIA Sleep","PROSOMNIA Sleep Therapy","PSTx","PROSOMNIA","Anesthesia Sleep","REM Sleep","REM Sleep Therapy","PROSOMNIA Sleep Health","PROSOMNIA Sleep Wellness","PROSOMNIA Sleep Treatment","Nyree","Nyree Penn","Propofol","Propofol Sleep","Diprivan","Diprivan Sleep","PROSOMNIA Sleep Health and Wellness","Sleep Debt","2025-05-27",{"date":430,"type":38},"2025-05-28",{"date":432,"type":20},"2025-11-01",{"date":434,"type":20},"2026-05-01",{"name":421,"class":45},{"id":437,"slug":438,"hasResults":11,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":444,"targetDuration":446,"studyType":447,"phases":4,"briefSummary":448,"conditions":449,"keywords":792,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":834,"startDateStruct":836,"completionDateStruct":838,"leadSponsor":840,"locationsCount":133},"100193378","rare-disease-patient-registry--natural-history-study---coordination-of-rare-diseases-at-sanford-100193378","NCT01793168","Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford","Coordination of Rare Diseases at Sanford","CoRDS","Inclusion Criteria:\n\n* Diagnosis of a rare disease, a disease of unknown prevalence, undiagnosed or an unaffected carrier of a rare\u002Funcommon disease\n\nExclusion Criteria:\n\n* Diagnosis of a disease which is not rare",{"count":445,"type":20},20000,"100 Years","OBSERVATIONAL","CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases. This program allows patients and researchers to connect as easily as possible to help advance treatments and cures for rare diseases. The CoRDS team works with patient advocacy groups, individuals and researchers to help in the advancement of research in over 7,000 rare diseases. The registry is free for patients to enroll and researchers to access. Visit sanfordresearch.org\u002FCoRDS to enroll.",[450,451,452,453,454,455,456,457,458,459,460,461,462,463,464,465,466,467,26,468,469,470,471,472,473,474,475,476,477,478,479,480,481,482,483,484,485,486,487,488,489,490,491,492,493,494,495,496,497,498,499,500,501,502,503,504,505,506,507,508,509,510,511,512,513,514,515,516,517,518,519,520,521,522,523,524,525,526,527,528,529,530,531,532,533,534,535,536,537,538,539,540,541,542,543,544,545,546,547,548,549,550,551,552,553,554,555,556,557,558,559,560,561,562,563,564,565,566,567,568,569,570,571,572,573,574,575,576,577,578,579,580,581,582,583,584,585,586,587,588,589,590,591,592,593,594,595,596,597,598,599,600,601,602,603,604,605,606,607,608,609,610,611,612,613,614,615,616,617,618,619,620,621,622,623,624,625,626,627,628,629,630,631,632,633,634,635,636,637,638,639,640,641,642,643,644,645,646,647,648,649,650,651,652,653,654,655,656,657,658,659,660,661,662,663,664,665,666,667,668,669,670,671,672,673,674,675,676,677,678,679,680,681,682,683,684,685,686,687,688,689,690,691,692,693,694,695,696,697,698,699,700,701,702,703,704,705,706,707,708,709,710,711,712,713,714,715,716,717,718,719,720,721,722,723,724,725,726,727,728,729,730,731,732,733,734,735,736,737,738,739,740,741,742,743,744,745,746,747,748,749,750,751,752,753,754,755,756,757,758,759,760,761,762,763,764,765,766,767,768,769,770,771,772,773,774,775,776,777,778,779,780,781,782,783,784,785,786,787,788,789,790,791],"Rare Disorders","Undiagnosed Disorders","Disorders of Unknown Prevalence","Cornelia De Lange Syndrome","Prenatal Benign Hypophosphatasia","Perinatal Lethal Hypophosphatasia","Odontohypophosphatasia","Adult Hypophosphatasia","Childhood-onset Hypophosphatasia","Infantile Hypophosphatasia","Hypophosphatasia","Kabuki Syndrome","Bohring-Opitz Syndrome","Narcolepsy Without Cataplexy","Narcolepsy-cataplexy","Hypersomnolence Disorder","Idiopathic Hypersomnia Without Long Sleep Time","Idiopathic Hypersomnia With Long Sleep Time","Kleine-Levin Syndrome","Kawasaki Disease","Leiomyosarcoma","Leiomyosarcoma of the Corpus Uteri","Leiomyosarcoma of the Cervix Uteri","Leiomyosarcoma of Small Intestine","Acquired Myasthenia Gravis","Addison Disease","Hyperacusis (Hyperacousis)","Juvenile Myasthenia Gravis","Transient Neonatal Myasthenia Gravis","Williams Syndrome","Lyme Disease","Myasthenia Gravis","Marinesco Sjogren Syndrome(Marinesco-Sjogren Syndrome)","Isolated Klippel-Feil Syndrome","Frasier Syndrome","Denys-Drash Syndrome","Beckwith-Wiedemann Syndrome","Emanuel Syndrome","Isolated Aniridia","Axenfeld-Rieger Syndrome","Aniridia-intellectual Disability Syndrome","Aniridia - Renal Agenesis - Psychomotor Retardation","Aniridia - Ptosis - Intellectual Disability - Familial Obesity","Aniridia - Cerebellar Ataxia - Intellectual Disability","Aniridia - Absent Patella","Aniridia","Peters Anomaly - Cataract","Peters Anomaly","Potocki-Shaffer Syndrome","Silver-Russell Syndrome Due to Maternal Uniparental Disomy of Chromosome 11","Silver-Russell Syndrome Due to Imprinting Defect of 11p15","Silver-Russell Syndrome Due to 11p15 Microduplication","Syndromic Aniridia","WAGR Syndrome","Wolf-Hirschhorn Syndrome","4p16.3 Microduplication Syndrome","4p Deletion Syndrome, Non-Wolf-Hirschhorn Syndrome","Autosomal Recessive Stickler Syndrome","Stickler Syndrome Type 2","Stickler Syndrome Type 1","Stickler Syndrome","Mucolipidosis Type 4","X-linked Spinocerebellar Ataxia Type 4","X-linked Spinocerebellar Ataxia Type 3","X-linked Intellectual Disability - Ataxia - Apraxia","X-linked Progressive Cerebellar Ataxia","X-linked Non Progressive Cerebellar Ataxia","X-linked Cerebellar Ataxia","Vitamin B12 Deficiency Ataxia","Toxic Exposure Ataxia","Unclassified Autosomal Dominant Spinocerebellar Ataxia","Thyroid Antibody Ataxia","Sporadic Adult-onset Ataxia of Unknown Etiology","Spinocerebellar Ataxia With Oculomotor Anomaly","Spinocerebellar Ataxia With Epilepsy","Spinocerebellar Ataxia With Axonal Neuropathy Type 2","Spinocerebellar Ataxia Type 8","Spinocerebellar Ataxia Type 7","Spinocerebellar Ataxia Type 6","Spinocerebellar Ataxia Type 5","Spinocerebellar Ataxia Type 4","Spinocerebellar Ataxia Type 37","Spinocerebellar Ataxia Type 36","Spinocerebellar Ataxia Type 35","Spinocerebellar Ataxia Type 34","Spinocerebellar Ataxia Type 32","Spinocerebellar Ataxia Type 31","Spinocerebellar Ataxia Type 30","Spinocerebellar Ataxia Type 3","Spinocerebellar Ataxia Type 29","Spinocerebellar Ataxia Type 28","Spinocerebellar Ataxia Type 27","Spinocerebellar Ataxia Type 26","Spinocerebellar Ataxia Type 25","Spinocerebellar Ataxia Type 23","Spinocerebellar Ataxia Type 22","Spinocerebellar Ataxia Type 21","Spinocerebellar Ataxia Type 20","Spinocerebellar Ataxia Type 2","Spinocerebellar Ataxia Type 19\u002F22","Spinocerebellar Ataxia Type 18","Spinocerebellar Ataxia Type 17","Spinocerebellar Ataxia Type 16","Spinocerebellar Ataxia Type 15\u002F16","Spinocerebellar Ataxia Type 14","Spinocerebellar Ataxia Type 13","Spinocerebellar Ataxia Type 12","Spinocerebellar Ataxia Type 11","Spinocerebellar Ataxia Type 10","Spinocerebellar Ataxia Type 1 With Axonal Neuropathy","Spinocerebellar Ataxia Type 1","Spinocerebellar Ataxia - Unknown","Spinocerebellar Ataxia - Dysmorphism","Non Progressive Epilepsy and\u002For Ataxia With Myoclonus as a Major Feature","Spasticity-ataxia-gait Anomalies Syndrome","Spastic Ataxia With Congenital Miosis","Spastic Ataxia - Corneal Dystrophy","Spastic Ataxia","Rare Hereditary Ataxia","Rare Ataxia","Recessive Mitochondrial Ataxia Syndrome","Progressive Epilepsy and\u002For Ataxia With Myoclonus as a Major Feature","Posterior Column Ataxia - Retinitis Pigmentosa","Post-Stroke Ataxia","Post-Head Injury Ataxia","Post Vaccination Ataxia","Polyneuropathy - Hearing Loss - Ataxia - Retinitis Pigmentosa - Cataract","Muscular Atrophy - Ataxia - Retinitis Pigmentosa - Diabetes Mellitus","Non-hereditary Degenerative Ataxia","Paroxysmal Dystonic Choreathetosis With Episodic Ataxia and Spasticity","Olivopontocerebellar Atrophy - Deafness","NARP Syndrome","Myoclonus - Cerebellar Ataxia - Deafness","Multiple System Atrophy, Parkinsonian Type","Multiple System Atrophy, Cerebellar Type","Multiple System Atrophy","Maternally-inherited Leigh Syndrome","Machado-Joseph Disease Type 3","Machado-Joseph Disease Type 2","Machado-Joseph Disease Type 1","Leigh Syndrome","Late-onset Ataxia With Dementia","Infection or Post Infection Ataxia","GAD Ataxia","Hereditary Episodic Ataxia","Gliadin\u002FGluten Ataxia","Friedreich Ataxia","Fragile X-associated Tremor\u002FAtaxia Syndrome","Familial Paroxysmal Ataxia","Exposure to Medications Ataxia","Episodic Ataxia With Slurred Speech","Episodic Ataxia Unknown Type","Episodic Ataxia Type 7","Episodic Ataxia Type 6","Episodic Ataxia Type 5","Episodic Ataxia Type 4","Episodic Ataxia Type 3","Episodic Ataxia Type 1","Epilepsy and\u002For Ataxia With Myoclonus as Major Feature","Early-onset Spastic Ataxia-neuropathy Syndrome","Early-onset Progressive Neurodegeneration - Blindness - Ataxia - Spasticity","Early-onset Cerebellar Ataxia With Retained Tendon Reflexes","Early-onset Ataxia With Dementia","Childhood-onset Autosomal Recessive Slowly Progressive Spinocerebellar Ataxia","Dilated Cardiomyopathy With Ataxia","Cataract - Ataxia - Deafness","Cerebellar Ataxia, Cayman Type","Cerebellar Ataxia With Peripheral Neuropathy","Cerebellar Ataxia - Hypogonadism","Cerebellar Ataxia - Ectodermal Dysplasia","Cerebellar Ataxia - Areflexia - Pes Cavus - Optic Atrophy - Sensorineural Hearing Loss","Brain Tumor Ataxia","Brachydactyly - Nystagmus - Cerebellar Ataxia","Benign Paroxysmal Tonic Upgaze of Childhood With Ataxia","Autosomal Recessive Syndromic Cerebellar Ataxia","Autosomal Recessive Spastic Ataxia With Leukoencephalopathy","Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay","Autosomal Recessive Spastic Ataxia - Optic Atrophy - Dysarthria","Autosomal Recessive Spastic Ataxia","Autosomal Recessive Metabolic Cerebellar Ataxia","Autosomal Dominant Spinocerebellar Ataxia Due to Repeat Expansions That do Not Encode Polyglutamine","Autosomal Recessive Ataxia, Beauce Type","Autosomal Recessive Ataxia Due to Ubiquinone Deficiency","Autosomal Recessive Ataxia Due to PEX10 Deficiency","Autosomal Recessive Degenerative and Progressive Cerebellar Ataxia","Autosomal Recessive Congenital Cerebellar Ataxia Due to MGLUR1 Deficiency","Autosomal Recessive Congenital Cerebellar Ataxia Due to GRID2 Deficiency","Autosomal Recessive Congenital Cerebellar Ataxia","Autosomal Recessive Cerebellar Ataxia-pyramidal Signs-nystagmus-oculomotor Apraxia Syndrome","Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome Due to WWOX Deficiency","Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome Due to TUD Deficiency","Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome Due to KIAA0226 Deficiency","Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome","Autosomal Recessive Cerebellar Ataxia With Late-onset Spasticity","Autosomal Recessive Cerebellar Ataxia Due to STUB1 Deficiency","Autosomal Recessive Cerebellar Ataxia Due to a DNA Repair Defect","Autosomal Recessive Cerebellar Ataxia - Saccadic Intrusion","Autosomal Recessive Cerebellar Ataxia - Psychomotor Retardation","Autosomal Recessive Cerebellar Ataxia - Blindness - Deafness","Autosomal Recessive Cerebellar Ataxia","Autosomal Dominant Spinocerebellar Ataxia Due to a Polyglutamine Anomaly","Autosomal Dominant Spinocerebellar Ataxia Due to a Point Mutation","Autosomal Dominant Spinocerebellar Ataxia Due to a Channelopathy","Autosomal Dominant Spastic Ataxia Type 1","Autosomal Dominant Spastic Ataxia","Autosomal Dominant Optic Atrophy","Ataxia-telangiectasia Variant","Ataxia-telangiectasia","Autosomal Dominant Cerebellar Ataxia, Deafness and Narcolepsy","Autosomal Dominant Cerebellar Ataxia Type 4","Autosomal Dominant Cerebellar Ataxia Type 3","Autosomal Dominant Cerebellar Ataxia Type 2","Autosomal Dominant Cerebellar Ataxia Type 1","Autosomal Dominant Cerebellar Ataxia","Ataxia-telangiectasia-like Disorder","Ataxia With Vitamin E Deficiency","Ataxia With Dementia","Ataxia - Oculomotor Apraxia Type 1","Ataxia - Other","Ataxia - Genetic Diagnosis - Unknown","Acquired Ataxia","Adult-onset Autosomal Recessive Cerebellar Ataxia","Alcohol Related Ataxia","Multiple Endocrine Neoplasia","Multiple Endocrine Neoplasia Type II","Multiple Endocrine Neoplasia Type 1","Multiple Endocrine Neoplasia Type 2","Multiple Endocrine Neoplasia, Type IV","Multiple Endocrine Neoplasia, Type 3","Multiple Endocrine Neoplasia (MEN) Syndrome","Multiple Endocrine Neoplasia Type 2B","Multiple Endocrine Neoplasia Type 2A","Atypical Hemolytic Uremic Syndrome","Atypical HUS","Wiedemann-Steiner Syndrome","Breast Implant-Associated Anaplastic Large Cell Lymphoma","Autoimmune\u002FInflammatory Syndrome Induced by Adjuvants (ASIA)","Hemophagocytic Lymphohistiocytosis","Behcet's Disease","Alagille Syndrome","Inclusion Body Myopathy With Early-onset Paget Disease and Frontotemporal Dementia (IBMPFD)","Lowe Syndrome","Pitt Hopkins Syndrome","1p36 Deletion Syndrome","Jansen Type Metaphyseal Chondrodysplasia","Cockayne Syndrome","Chronic Recurrent Multifocal Osteomyelitis","CRMO","Malan Syndrome","Hereditary Sensory and Autonomic Neuropathy Type Ie","VCP Disease","Hypnic Jerking","Sleep Myoclonus","Mollaret Meningitis","Recurrent Viral Meningitis","CRB1","Leber Congenital Amaurosis","Retinitis Pigmentosa","Rare Retinal Disorder","KCNMA1-Channelopathy","Primary Biliary Cirrhosis","ZMYND11","Transient Global Amnesia","Glycogen Storage Disease","Alstrom Syndrome","White Sutton Syndrome","DNM1","EIEE31","Myhre Syndrome","Recurrent Respiratory Papillomatosis","Laryngeal Papillomatosis","Tracheal Papillomatosis","Refsum Disease","Nicolaides Baraitser Syndrome","Leukodystrophy","Tango2","Cauda Equina Syndrome","Rare Gastrointestinal Disorders","Achalasia-Addisonian Syndrome","Achalasia Cardia","Achalasia Icrocephaly Syndrome","Anal Fistula","Congenital Sucrase-Isomaltase Deficiency","Eosinophilic Gastroenteritis","Idiopathic Gastroparesis","Hirschsprung Disease","Rare Inflammatory Bowel Disease","Intestinal Pseudo-Obstruction","Scleroderma","Short Bowel Syndrome","Sacral Agenesis","Sacral Agenesis Syndrome","Caudal Regression","Scheuermann Disease","SMC1A Truncated Mutations (Causing Loss of Gene Function)","Cystinosis","Juvenile Nephropathic Cystinosis","Nephropathic Cystinosis","Kennedy Disease","Spinal Bulbar Muscular Atrophy","Warburg Micro Syndrome","Mucolipidoses","Mitochondrial Diseases","Mitochondrial Aminoacyl-tRNA Synthetases","Mt-aaRS Disorders","Hypertrophic Olivary Degeneration","Non-Ketotic Hyperglycinemia","Fish Odor Syndrome","Halitosis","Isolated Congenital Asplenia","Lambert Eaton (LEMS)","Biliary Atresia","STAG1 Gene Mutation","Coffin Lowry Syndrome","Borjeson-Forssman-Lehman Syndrome","Blau Syndrome","Arginase 1 Deficiency","HSPB8 Myopathy","Beta-Mannosidosis","TBX4 Syndrome","DHDDS Gene Mutations","MAND-MBD5-Associated Neurodevelopmental Disorder","Constitutional Mismatch Repair Deficiency (CMMRD)","SPATA5 Disorder","SPATA5L1 Related Disorder","Acrodysostosis","Multi-systematic Smooth Muscle Dysfunction Syndrome","CRELD1 (Cysteine Rich With EGF Like Domains 1)","GNB1 Syndrome","Pyruvate Dehydrogenase Complex Deficiency Disease","Beta Mannosidosis","Kbg Syndrome","Labrune Syndrome","Metachromatic Leukodystrophy (MLD)","Moyamoya Disease","OPHN1 Syndrome","Oculopharyngeal Muscular Dystrophy (OPMD)","TUBB3 Mutation","WOREE (WWOX-related Epileptic Encephalopathy","SCAR12","Skraban-Deardorff Syndrome","Hereditary Myopathy With Early Respiratory Failure",[793,794,795,796,797,503,798,799,510,800,469,801,802,803,673,682,804,805,461,806,807,468,808,470,809,460,148,810,685,811,812,688,689,813,691,692,814,815,695,816,817,818,745,819,820,821,822,823,824,825,750,826,827,828,755,756,829,830,831,832,833],"Rare Diseases","Neglected Diseases","Orphan Diseases","Rare Disease Research","Registries","Ataxia","Cornelia de Lange Syndrome","Ataxia Telangiectasia","Batten Disease","Mucolipidosis IV","Klippel-Feil Syndrome","Undiagnosed","Uncommon Disease","Hypersomnia","Hyperacusis","Marinesco-Sjogren Syndrome","4p-\u002FWolf-Hirschhorn Syndrome","Wiedermann-Steiner Syndrome","Autoimmune\u002Finflammatory Syndrome Induced by Adjuvants (ASIA)","Hemophagocytic Lymphohistiocytosis (HLH)","Inclusion body myopathy with early-onset Paget disease and frontotemporal dementia (IBMPFD)","1p36 deletion syndrome","Jansen metaphyseal chondrodysplasia","Chronic recurrent multifocal osteomyelitis (CRMO)","Malan syndrome","Hereditary Sensory and Autonomic Neuropathy","Juvenile nephropathic cystinosis","Nephropathic infantile cystinosis","Ocular cystinosis","Kennedy disease","Spinal Bulbar Muscular Atrophy (SBMA)","SMC1A Truncated Mutations (causing loss of gene function)","Leigh syndrome","Mucolipidosis","Mitochondrial aminoacyl-tRNA synthetases (Mt-aaRS Disorders)","Shine Syndrome","Intestinal Bromhidrosis Syndrome","Fish odor syndrome","Autosomal recessive extra oral halitosis","CACNA1H mutation","Dimethylglycine dehydrogenase deficiency",{"date":835,"type":38},"2025-05-29",{"date":837,"type":38},"2010-07",{"date":839,"type":20},"2100-12",{"name":841,"class":132},"Sanford Health",{"id":843,"slug":844,"hasResults":11,"nctId":845,"briefTitle":846,"officialTitle":847,"acronym":848,"eligibilityCriteria":849,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":111,"enrollmentInfo":850,"targetDuration":4,"studyType":21,"phases":852,"briefSummary":853,"conditions":854,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":856,"lastUpdatePostDateStruct":857,"startDateStruct":859,"completionDateStruct":861,"leadSponsor":863,"locationsCount":73},"100551273","mind-wandering-and-predictive-processes-in-narcolepsy-a-putative-mechanism-through-covert-rem-intrusions-100551273","NCT06457945","Mind-wandering and Predictive Processes in Narcolepsy: a Putative Mechanism Through Covert REM Intrusions","Mind-wandering and Predictive Processes in Narcolepsy: a Putative Mechanism Through Covert REM Intrusions, the NarcoWandering Study","NARCOWANDERING","Inclusion Criteria:\n\n* Patients with NT1 or IH diagnosis according to ICSD3-TR criteria (American Academy of Sleep, 2023)\n* For patient with IH: with abnormal Mean Sleep Latency Test (MSLT) (mean latency ≤ 8 min, ≤ 1 SOREMp)\n* Patients with subjective hypersomnolence without underlying cause (negative extensive work-up including actigraphy, PSG, MSLT, 24h bedrest, biological tests, MRI, psychiatric consultation; this allows to rule out sleep deprivation, irregular sleep\u002Fwake schedule, sleep apnea or other sleep disorders associated with sleep fragmentation, somatic\u002Fpsychiatric causes of hypersomnolence, sedative substance intake). This type of \"controls\" have already been used in studies on hypersomnolence disorders.\n\nExclusion Criteria:\n\n* Cognitive impairment not compatible with the task\n* Treatment with antidepressant\n* Other cause of hypersomnolence: untreated severe obstructive sleep apnea, sleep-wake circadian rhythm disorders, sleep deprivation, somatic\u002Fpsychiatric causes of hypersomnolence, sedative substance intake\n* Unstable medical or psychiatric condition\n* Refusal to participate",{"count":851,"type":20},180,[115],"Mind wandering is a state in which attention turns away from the external environment or current task to focus on internal thoughts (past experiences, future events, planned actions...). Humans are thought to spend at least one third of their waking lives in this state. Mind wandering can be assessed experimentally by investigating mental content during well-controlled tasks. In this case, task-unrelated thoughts likely to arise during tasks of varying cognitive demand are studied. Mind wandering (=task-unrelated thoughts) has a deleterious effect on cognitive performance in most paradigms, particularly those requiring sustained attention and executive control. However, this phenomenon could also have cognitive benefits, although knowledge on this issue remains limited. For example, it has been suggested that mind wandering could promote creativity, anticipation of future scenarios and prospective memory. In a recent behavioural study, we investigated the cost and benefit of mind wandering in an implicit visual-motor probabilistic learning task (ASRT - Alternating Serial Reaction Time Task). ASRT distinguishes between two fundamental processes: visuomotor performance and implicit statistical learning. While the former reflects visuo-spatial discrimination efficiency, the latter refers to the unintentional acquisition of probabilistic regularities of external inputs. Reduced visuo-spatial accuracy and faster but less accurate responses have been observed during periods of mind-wandering. On the other hand, mind-wandering was associated with enhanced statistical learning reflecting improved predictive processing.\n\nWhereas the study of the neural correlates of mind-wandering is constantly growing, the mechanisms triggering mind-wandering are far from being unravelled, but may involve sleep pressure. Thus, the frequency of mind wandering tends to increase after sleep deprivation or during attention-demanding cognitive tasks, during which neurophysiological markers of local sleep appear. These markers of sleep during wakefulness are frequently observed in hypersomnolence disorders. They are generally defined by the appearance of slow waves (typical of slow wave sleep, SWS). Nevertheless, sleep intrusions during wakefulness may not be limited to non-rapid-eye-movement (NREM) sleep but also concern REM sleep. REM sleep is the sleep state when the most intense forms of dreaming occur, and could therefore be phenomenologically similar to the reverie of mind wandering. Thus, daytime mental wandering could be triggered by intrusions of REM sleep during wakefulness.\n\nPatients with narcolepsy type 1 (NT1) exhibit frequent REM sleep onset during daytime wakefulness. The study of ASRT in this population therefore offers a unique opportunity to investigate the role of REM sleep intrusions in mind wandering. The hypothesis is that mind wandering would be observed more frequently during the ASRT task in NT1 patients (with REM sleep intrusions during wakefulness) than in patients with idiopathic hypersomnia (IH) (with NREM sleep intrusions during wakefulness) and patients with subjective hypersomnolence (little or no sleep intrusion). Furthermore, it could be possible that REM sleep-related mind wandering would be associated with impaired visuomotor performance in terms of accuracy, but improved predictive processing (probabilistic learning) compared to NREM sleep intrusions or no sleep intrusion during the task.",[61,855,26],"Hypersomnolence","2025-01-10",{"date":858,"type":38},"2025-01-13",{"date":860,"type":38},"2024-12-03",{"date":862,"type":20},"2026-12-03",{"name":131,"class":132},{"id":865,"slug":866,"hasResults":11,"nctId":867,"briefTitle":868,"officialTitle":869,"acronym":870,"eligibilityCriteria":871,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":872,"enrollmentInfo":873,"targetDuration":4,"studyType":21,"phases":875,"briefSummary":876,"conditions":877,"keywords":878,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":882,"lastUpdatePostDateStruct":883,"startDateStruct":885,"completionDateStruct":887,"leadSponsor":889,"locationsCount":73},"100561476","phase-2-efficacy-and-tolerance-of-solriamfetol-in-patients-affected-with-idiopathic-hypersomnia-100561476","NCT06590662","Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.","A Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.","SOLR-IH","Main inclusion criteria:\n\n* Age between 18 and 60 years-old\n* BMI between 18 and 30 kg\u002Fm2\n* Diagnostic of idiopathic hypersomnia (ICSD-3 criteria) made in the last 5 years, based on Polysomnography (PSG) and Multiple Sleep Latency Test (MSLT) results, showing either: a mean sleep latency (MSL) of ≤8 minutes and \\\u003C 2 SOREMPs and\u002For a 24-h long term polysomnography recording showing total sleep time \\>11h\u002F24 hours.\n* Apnea-hypopnea index (AHI) \\\u003C15\u002Fhour, Apnea index \\\u003C10\u002Fhour, micro-arousals index \\\u003C15\u002Fhour, Periodic limb movement (PLM) index associated with micro-arousals \\\u003C15\u002Fhour on the PSG and MSLT performed within the past 5 years.\n* Absence of sleep deprivation, assessed by actigraphy or sleep logs for the 7 days preceding study inclusion\n* ESS score ≥11 points\n* Written informed consent\n* National health insurance coverage\n* Understand, read and speaks French well\n* The participant agrees to follow the contraceptive requirements detailed in the protocol.\n\nMain non-inclusion criteria\n\n* Non-stabilized hypertension\n* To be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within the past year before screening, or has positive answers on items number 4 or 5 on the Colombia-Suicide Severity Rating Scale (based on the 6 months before randomization).\n* Other psychiatric conditions in the past 6 months\n* Presence of other central nervous system diseases: neurodegenerative diseases, seizure disorders, or history of head trauma associated with loss of consciousness\n* Prior history of psychotic episodes\n* Psychostimulant treatment with modafinil, methylphenidate, mazindol, pitolisant, ongoing or within 15 days prior to visit 1\n* Treatment for obstructive sleep apnea-hypopnea syndrome ongoing or within 15 days prior to visit 1\n* Treatment with psychotropic drugs: neuroleptics (i.e. clozapine, olanzapine, aripiprazole, …), sedative hypnotics (benzodiazepines, zolpidem, zopiclone), central nervous system depressants (barbiturates, …), antidepressants (SSRI (e.g. fluoxetine, sertraline, paroxetine…), serotonin and norepinephrine reuptake inhibitors (SRNI : e.g. venlafaxine, duloxetine), Monoamine oxidase inhibitors), anxiolytic drugs, anticonvulsive therapy (i.e. topiramate, inhibitors of GHB dehydrogenase (i.e. valproate, ethosuximide, phenytoin), or drugs for pain (level 2 (e.g. codeine, tramadol), and level 3 (morphine and derivatives)), ongoing or within 30 days prior to visit 1.\n* Treatment with dopamine antagonist antiemetics except domperidone, Catechol-O-methyltransferase (COMT) inhibitors, or sedative antihistamines ongoing or within 30 days prior to visit 1\n\n  =\\> Of note, for all the above treatments: if patient has received such therapy, a washout-period of at least 15 days, or equivalent to 5 half-lives of the drug, prior to the inclusion in the study is required before starting treatment in this study. Of note, for antidepressants, a washout of at least 30 days should be required.\n* Previously treated with solriamfetol\n* History of chronic alcohol or drug abuse within the prior 12 months\n* Malignant neoplastic disease requiring therapy within 12 months prior to Visit 1 or clinically relevant\n* Heart failure, unstable hypertension or other cardiovascular disease compromising the patient's wellbeing or ability to participate in this study\n* Renal or hepatic impairment\n* No regular sleep at night: shift work or other continuous non-disease-related life conditions\n* Has received any other investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening or plans to use an investigational drug (other than the study intervention) during the study","60 Years",{"count":874,"type":20},60,[58],"This Phase II clinical trial is a monocenter, double-blind, randomized, placebo-controlled study aimed at evaluate the efficacy and safety of solriamfetol from 75 to 300 mg per day in IH patients.\n\nPatients will be randomized (1:1) to receive either solriamfetol or placebo, with titration, every morning upon awakening during all treatment periods (Day 0 to Week 7).",[26],[879,880,881],"Idiopathic hypersomnia","Solriamfetol","polysomnography","2024-09-09",{"date":884,"type":38},"2024-09-19",{"date":886,"type":20},"2024-09-15",{"date":888,"type":20},"2027-06-01",{"name":890,"class":132},"University Hospital, Montpellier",{"id":892,"slug":893,"hasResults":11,"nctId":894,"briefTitle":895,"officialTitle":895,"acronym":896,"eligibilityCriteria":897,"healthyVolunteers":110,"sex":16,"minAge":898,"maxAge":82,"enrollmentInfo":899,"targetDuration":901,"studyType":447,"phases":4,"briefSummary":902,"conditions":903,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":904,"lastUpdatePostDateStruct":905,"startDateStruct":907,"completionDateStruct":909,"leadSponsor":910,"locationsCount":73},"100387916","international-swiss-primary-hypersomnolence-and-narcolepsy-cohort-study-100387916","NCT04330963","International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study","iSPHYNCS","Inclusion Criteria:\n\nStudy participants:\n\n* Subjective complaints of Excessive daytime sleepiness (EDS) and\u002For Hypersomnia (H) as defined above\n* EDS and\u002For H present daily or almost daily for at least 1 month prior to the consultation\n* Ability and consent to undergo electrophysiological routine assessment\n* Ability to give informed consent\n\nHealthy controls:\n\n* Age and gender matched healthy subjects\n* Including blood related relatives of study participants\n* Ability and consent to undergo electrophysiological routine assessment\n* Ability to give informed consent\n\nControls with Sleep disordered breathing (SDB):\n\n* Subjective complaints of EDS with Epworth Sleepiness Scale (ESS) \\> 10 (adults) and\u002For H due to SDB: Presence of clinically significant and untreated obstructive sleep apnea (OSA) as determined by the investigator with an apnea-hypopnea-index \\>30\u002Fh\n* Multiple sleep-latency test (MSLT) mean sleep latency ≤ 8min\n* Subjective and objective improvement of EDS and\u002For H within 3 months after treatment with\n* Positive airway pressure (PAP) therapy with documented\n\n  * Reduction of apnea-hypopnea index below \\\u003C10\u002Fh\n  * Reduction of ESS by ≥ 25%\n  * MSLT mean Sleep Latency \\> 12min\n* Ability and consent to undergo electrophysiological routine assessment\n* Ability to give informed consent\n\nExclusion Criteria:\n\nStudy participants and controls:\n\n* SDB for study participants and healthy controls: Presence of clinically significant and untreated obstructive sleep apnea (OSA) or central sleep apnea (CSA) as determined by the investigator or documented previously; or documentation of one of the following:\n\n  * Apnea index (AI) \\> 10 if on OSA treatment or untreated; or\n  * Clinically significant hypoventilation; or\n  * Noncompliance with primary OSA therapy\n  * except if NT1 has been diagnosed including decreased or missing cerebrospinal fluid (CSF) hypocretin\n* SDB for control population with SDB:\n\n  * Central Sleep Apnea (CSA)\n  * Noncompliance with primary OSA therapy and\u002For\n  * No reported improvement of EDS and\u002For H within 3 months of positive airway pressure (PAP) treatment\n* The following disorders\u002Fconditions that on clinical grounds are considered to be the cause of EDS \u002F H\n\n  * Other sleep disorders (e.g. Restless legs syndrome (RLS) with periodic leg movement syndrome (PLMS), sleepwalking, clear-cut circadian disorder)\n  * Other neurological disorders (e.g. stroke, multiple sclerosis, parkinsonism, severe traumatic brain injury)\n  * (Auto-)immune and systemic disorders (such as Hashimoto Thyroiditis, Chron's Disease, ulcerous colitis, Diabetes mellitus type I, Systemic lupus erythematosus)\n  * Malignancy (except: Status in Remission for at least \\> 10 years)\n  * Instable psychiatric disorder (e.g. acute psychotic, acute suicidal, episode of major depression requiring in-hospital treatment, active substance abuse)\n  * Active infectious disease at screening\n  * Permanent medications \u002F drugs\n* Chronic infectious diseases (such as Hepatitis B\u002FC, HIV)\n* Chronic use of antibiotics\n* Recent use (\\\u003C 8 weeks) of immune-modulating drugs\n\nHealthy controls additional:\n\n* Subjective complaints of EDS and \u002F or H\n* ESS \\> 10\n* Polysomnography (PSG) with AI \\> 10\u002Fh and \u002F or PLMS Index \\> 30\u002Fh\n* MSLT mean Sleep Latency \\\u003C 12 min","10 Years",{"count":900,"type":20},600,"36 Months","Swiss Primary Hypersomnolence and Narcolepsy Cohort Study (SPHYNCS) is a cohort study on disease presentation and long-term course with an exploratory approach to detect biomarkers.",[148,26,465],"2023-04-17",{"date":906,"type":38},"2023-04-20",{"date":908,"type":38},"2020-01-06",{"date":35,"type":20},{"name":911,"class":132},"Insel Gruppe AG, University Hospital Bern",{"id":913,"slug":914,"hasResults":11,"nctId":915,"briefTitle":916,"officialTitle":917,"acronym":918,"eligibilityCriteria":919,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":920,"enrollmentInfo":921,"targetDuration":922,"studyType":447,"phases":4,"briefSummary":923,"conditions":924,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":930,"lastUpdatePostDateStruct":931,"startDateStruct":933,"completionDateStruct":935,"leadSponsor":937,"locationsCount":73},"100463950","mainz-register-of-patients-with-sleep-disorders-100463950","NCT05321355","Mainz Register of Patients With Sleep Disorders","Study on Disease Course and Quality of Life in Patients With Sleep Disorders (Mainz Sleep Registry)","MAINZ-SLEEPREG","Inclusion Criteria:\n\n* patients with narcolepsy\n* patients with other neurological sleep disorders\n\nExclusion Criteria:\n\n* patients aged \\\u003C18 years\n* patients who cannot provide informed consent and don't have a legal guardian","120 Years",{"count":56,"type":20},"3 Years","Prospective longitudinal observational registry study of all patients with sleep disorders treated in the Mainz Comprehensive Epilepsy and Sleep Medicine Center with the focus on the course of the disease and quality of life.",[925,926,148,927,377,928,26,929,374],"Sleep Disorder","Sleep Disorder Parasomnia","Sleep Apnea","Somnambulism","Restless Legs Syndrome","2022-09-11",{"date":932,"type":38},"2022-09-15",{"date":934,"type":38},"2022-02-01",{"date":936,"type":20},"2030-01-31",{"name":938,"class":132},"Johannes Gutenberg University Mainz"]