[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rem-sleep-behavior-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rem-sleep-behavior-disorder":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,43,72,99,125,145,168,193,212,236,255,299,377,399,423],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100592686","phase-2-an-exploratory-study-of-the-potential-for-rational-immune-system-manipulation-to-prevent-emergence-of-synucleinopathy-manifestations-in-persons-with-rem-sleep-behavior-disorder-rbd-100592686",false,"NCT06996652","An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Persons With REM Sleep Behavior Disorder (RBD)","PRISMS","Inclusion Criteria:\n\n* Males, or females who are either\n\n  1. post-menopausal or otherwise not of child-bearing potential, defined as either 1) having had no menses for 12 or months without an alternative medical cause or explanation or 2) having undergone a surgical procedure (hysterectomy, bilateral tubal ligation) that prevents conception, or\n  2. practicing adequate contraception. Female participants of childbearing potential must practice at least 1 protocol-specified method of birth control, that is effective from 30 days before baseline (or earlier) through at least 150 days after the last dose of the study drug. Female participants of non-childbearing potential do not need to use birth control.\n* Diagnosis of idiopathic REM sleep behavior disorder Diagnosis of idiopathic REM Sleep Behavior Disorder (RBD) based upon:\n\n  1. History of Dream Enactment Behavior during sleep and\n  2. Evidence of REM sleep without muscle atonia based upon polysomnogram obtained in a qualified sleep laboratory, consistent with ICSD-3 Diagnostic Criteria for RBD\n* Hyposmia, defined as score \\\u003C 15th percentile for age-and gender-specific normal values\n* Not diagnosed with motor parkinsonism or Lewy body dementia\n* Have a MoCA score at screening and baseline \\>23\n* Able to speak, read and write fluently in the official language of the site's geographical region\n* Participant must be willing and able to attend all study visits as required by the study protocol\n* Participant must have a study partner who is in regular contact with the subject and can accompany the subject to clinic visits and report on subject's functional status\n* Participant must be able to self-inject study drug regularly or have a study partner who is available, willing and able to do so\n* Participant must be able to understand the study requirements and provide written informed consent\n\nExclusion Criteria:\n\n* Alternative explanation or etiology for the presence of RBD (e.g. narcolepsy)\n* Other than RBD, neurologic or medical disorder which may impair cognition including: head trauma, seizure disorder, neurodegenerative disease, hydrocephalus, cerebral\u002Fspinal hematoma, inflammatory disease, CNS infection (e.g., encephalitis or meningitis), neoplasm, toxic exposure, metabolic disorder (including hypoxic or hypoglycemic episodes), or endocrine disorder, or any significant medical conditions that, in the opinion of the investigator, would prohibit their participation in the study.\n* As assessed by the central reader, MRI evidence of (a) more than three lacunar infarcts, (b) territorial infarct or macroscopic hemorrhage, or (c) deep white matter lesions corresponding to a Fazekas score of 3\n* Any contra-indication to undergo MRI, as judged by local PI or radiologist, including but not limited to presence of pacemaker, aneurysm clips, artificial heart valves, ear implants, ventriculoperitoneal shunt, foreign metal objects in the eyes, skin or body or any other circumstance which would contra-indicate an MRI scan or impair MRI image quality, or history of claustrophobia or of not tolerating MRI scanning procedures\n* History or active presence of any of the following neurological, psychiatric or medical conditions:\n\n  1. Large vessel stroke\n  2. Peripheral or CNS demyelinating disease\n  3. Chronic and\u002For recurrent fungal, bacterial or opportunistic infections\n  4. Myocardial infarction or unstable angina within the previous 12 months\n  5. Clinically relevant or significant ECG abnormalities, including ECG with QT interval corrected for heart rate using Fridericia's formula (QT interval corrected for heart rate using Fridericia's formula) \\> 450 msec (males) or \\> 470 msec (females).\n  6. Congestive heart failure, NYHA Class 3 or 4\n  7. Autoimmune disease (e.g., Systemic Lupus Erythematosis (SLE), or symptoms suggestive of a lupus-like syndrome, multiple sclerosis, rheumatoid arthritis, Type 1 diabetes mellitus, inflammatory bowel disease, psoriasis, etc.)\n  8. Immunocompromised systemically due to continuing effects of immune suppressing medication\n  9. Current or previous hepatitis B infection (defined as positive test for hepatitis B surface antigen (HbSAg) and\u002For hepatitis B core antibody (anti-HBc).\n\n     Participants with immunity to hepatitis B (if due to natural infection defined as negative HBsAg, positive hepatitis B antibody (anti-HBs) and positive anti-HBc; if due to vaccination defined as negative HBsAg, negative anti-HBc and positive anti-HBs are eligible to participate in the study For patients with resolved HBV infection, if anti-HBc negative, HBV DNA testing is needed prior to initiating study drug\n  10. History or positive test at Screening for hepatitis C virus antibody (anti-HCV) in the absence of treatment resulting in cure\n  11. History or positive test at Screening for human immunodeficiency virus (HIV)\n  12. History of untreated or incompletely treated tuberculosis or a positive tuberculosis IGRA test.\n  13. History of malignancy other than successfully treated, non-metastatic cutaneous squamous or basal cell carcinoma or localized carcinoma in situ of the cervix\n  14. Major depressive episode requiring initiation of medication or hospitalization within the previous 90 days\n  15. Seated blood pressure \\> 150\u002F90 on 3 separate determinations\n  16. Presence of hallucinations or delusions\n  17. Psychiatric disorder (schizophrenia, schizoaffective disorder, etc.) associated with psychosis\n  18. Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral\u002Fintramuscular anti-infectives within 14 days prior to baseline\n  19. Major surgery within 12 weeks of screening\n  20. Blood donation of 1 unit or more within 8 weeks prior to the first dose of study medication\n* Any of the following laboratory abnormalities at Screening\n\n  1. Screening values for hemoglobin \\\u003C 12 g\u002Fd for men or \\\u003C 11 g\u002FdL for women or other clinically significant hematological abnormality\n  2. Any serum chemistry value (e.g., AST, ALT, alkaline phosphatase, CK, total bilirubin etc. \\> 2x the upper limit of normal on 2 successive determinations less than 2 weeks apart\n  3. Serum creatinine above the ULN or eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2\n  4. Platelet count, INR, PT or PTT not within the normal range or other risk for increased or uncontrolled bleeding\n* Any other significant medical conditions that, in the opinion of the investigator, would prohibit participation in the study, including inability to tolerate the MRI scan\n* For participants agreeing to lumbar puncture: Presence of contra-indication to lumbar puncture as judged by local PI (e.g., known X-ray or other evidence of significant lumbar spine abnormalities or history of lumbar surgery with sequalae that would interfere with or pose risks from the procedure; platelet count below 50,000 cells\u002FmL; need for anticoagulant or antiplatelet medications other than aspirin at a dose of \\\u003C 100 mg\u002Fday or clopidogrel (see item 10 (g) below))\n* Taking any of the following medications:\n\n  1. Symptomatic anti-Parkinson agents, including but not limited to levodopa-containing preparations, dopamine agonists, monoamine oxidase inhibitors, amantadine, and adenosine receptor antagonists taken any time prior to the screening visit\n  2. Cognitive enhancing agents, including but not limited to acetylcholinesterase inhibitors and memantine taken any time prior to the screening visit\n  3. Stimulant medications, including but not limited to lisdexamphetamine, dextroamphetamine\u002Famphetamine (Adderall) and methylphenidate taken at any time prior to the screening visit\n  4. Antipsychotic agents, including pimavanserin\n  5. Antidepressant medications whose dose has not been stable for at least 90 days\n  6. Use of any of the following medications within 12 months prior to Screening: Immunosuppressant medications, including chronic corticosteroids, anakinra and abatacept\n  7. Any previous use of injected or infused antibody therapies, including but not limited antibodies directed against TNF, anti-IL-6, natalizumab, rituximab, conventional or targeted DMARD agents\n  8. For participants agreeing to undergo lumbar puncture: Anticoagulant or anti-platelet medications including warfarin, heparinoids and direct coagulation factor inhibitors (e.g., apixaban, dabigatran, rivaroxaban) within 90 days of the planned first dose of study drug; either aspirin at a dose of \\\u003C¬ 100 mg\u002Fday or clopidogrel at a dose of 75 mg\u002Fday, but use of both in combination is permitted.\n  9. Received any live vaccine, with the exception of non-replicating live viral vaccines such as Jynneos vaccine, within 30 days prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 70 days after the last dose of study drug.\n* History of an allergic reaction or significant sensitivity to adalimumab or constituents of the study drug (and its excipients) and\u002For other products in the same class\n* Participation in any other interventional clinical trial, or treatment with any investigational drug or investigational use of an approved therapy within 30 days (or 5 half-lives of such agent) prior to the first Screening visit.\n* History of drug or alcohol abuse within the last 5 years (including cannabis use disorder)\n* Positive urine drug test at screening\n* Unwillingness or inability to comply with study requirements, including self-administration of study medication, or history of noncompliance in prior clinical trials","ALL","50 Years","80 Years",{"count":20,"type":21},108,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a phase 2 study to assess the ability of adalimumab as compared to placebo to reduce or prevent progression of synuclein-related neurodegeneration in persons with idiopathic REM Sleep Behavior Disorder (RBD). The Primary Endpoint will be change from baseline in expression of the Parkinson Disease Related Pattern (PDRP) will be assessed using change in 18-flurodeoxyglucose (FDG) Positron Emission Tomography (PET) imaging.",[27],"REM Sleep Behavior Disorder",[29],"Parkinson Disease Related Pattern","NOT_YET_RECRUITING","2026-06-26",{"date":33,"type":34},"2026-06-30","ACTUAL",{"date":36,"type":21},"2026-06-29",{"date":38,"type":21},"2029-08-01",{"name":40,"class":41},"Yale University","OTHER",20,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100475517","neuroplasticity-in-rbd-100475517","NCT05471960","Neuroplasticity in RBD","Neuroplasticity in REM Sleep Behavior Disorder","Inclusion Criteria for the iRBD Group:\n\n* Diagnosis of polysomnogram-confirmed isolated iRBD.\n* Able to ambulate independently without the use of an assistive device (e.g., cane) for 50 meters.\n* Age: 21-75 years.\n\nInclusion Criteria For Control Subject Group:\n\n* Age: 21-75 years.\n* Able to ambulate independently without the use of an assistive device (e.g., cane or walker for 50 meters.\n\nExclusion criteria for iRBD group:\n\n* Dementia diagnosis and\u002For a University of California Brief Assessment of Capacity to Consent (UBACC) score and MacCAT-CR score indicating impaired capacity to consent.\n* History of musculoskeletal disorders that significant affect movement of lower or upper limbs as determined at the time of enrollment.\n* Other significant neurological disorders that may affect participation or performance in the study.\n* Anti-depressant associated RBD. Individuals will be excluded if their dream enactment emerged or clearly worsened after initiating an antidepressant medication.\n* Meet criteria for overt Parkinson's disease, dementia with Lewy bodies, Multiple Systems Atrophy, Alzheimer's disease, or other neurodegenerative disorder, or other known cause of RBD (e.g., narcolepsy and drug induced RBD).\n* Untreated sleep-disordered breathing\n* History of musculoskeletal disorders that significantly affect movement of lower or upper limbs as determined at the time of enrollment.\n* Pregnant women\n* Additional exclusion criteria for TMS experiments (note that individuals who are excluded from the TMS experiment still have the opportunity to participate in the other data collection sessions):\n\n  * History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury\n  * Recent history of frequent syncope (fainting) episodes in response to blood, emotional stress, or sensory triggers.\n  * Intracranial metallic or magnetic devices (e.g. cochlear implant, deep brain stimulator)\n  * Pacemaker or any implanted device\n  * History of surgery on blood vessels, brain, or heart\n  * Unexplained, recurring headaches or concussion within the last six months\n  * Severe hearing impairment\n  * If participant is taking one of the following medications that affects neuroplasticity testing, they will be excluded from the TMS experiment: haloperidol (dopamine antagonist), prazosin (norepinephrine antagonist), biperiden (acetylcholine antagonist), dopamine modulators, NMDA receptor and calcium channel modulators, GABAergic drugs (benzodiazepines), lithium, lovastatin, and cannabis.\n\nExclusion Criteria for Control subject Group:\n\n* Same as exclusion criteria as the iRBD group\n* History of dream enactment from either patient report or from a bed partner witness that may suggest iRBD.\n* History of untreated sleep-disordered breathing.\n* Presence of parkinsonism or cognitive impairment (including dementia or mild cognitive impairment).\n* Active central nervous system, systemic, psychiatric conditions or use of psychoactive medication that would adversely affect cognitive, neuropsychiatric, motor, or autonomic functioning",true,"21 Years","75 Years",{"count":54,"type":21},86,[56],"NA","REM sleep behavior disorder is a parasomnia that reflects the presence of alpha-synucleinopathy in the brain and is highly predictive of eventual phenoconversion to Parkinson's disease, dementia with Lewy bodies, or multiple system atrophy over the course of years to decades. Neuroplastic adaptations in the brain during the prodromal stage of disease are thought to mask the expression of motor and non-motor signs and may substantially delay diagnosis during a potentially critical time window. This study will examine the state and progression (over 30 to 36 months) of neuroplastic changes in the excitability of the motor and prefrontal cortex (using transcranial magnetic stimulation), the structural and functional connectivity of the brain (using highfield, 7T, magnetic resonance imaging), and the relationship of these changes to the expression of motor and neuropsychological signs, in a cohort of individuals with REM sleep behavior disorder and matched controls.",[27],[60],"iRBD","RECRUITING","2026-06-09",{"date":64,"type":34},"2026-06-10",{"date":66,"type":34},"2023-04-21",{"date":68,"type":21},"2027-07-31",{"name":70,"class":41},"University of Minnesota",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100193894","natural-history-study-of-synucleinopathies-100193894","NCT01799915","Natural History Study of Synucleinopathies","Inclusion Criteria:\n\n1. Both male and female patients will be included\n2. Aged 18 or over\n3. Referred to any of the participating consortium sites with orthostatic intolerance, defined as symptoms of dizziness or lightheadedness in the standing position that disappear when supine.\n\nExclusion Criteria:\n\n1. Diabetes according to the American Diabetes Association criteria\n2. Congestive heart failure\n3. Lupus or other collagen vascular disease\n4. Systemic illness thought to be responsible for the orthostatic intolerance\n5. Drug-induced orthostatic hypotension (i.e., the use of alpha-blockers, diuretics, tricyclic antidepressants or others thought by the investigator to play an important role in the patient's orthostatic hypotension)\n6. Isolated vasovagal syncope\n7. Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.","18 Years",{"count":80,"type":21},800,"OBSERVATIONAL","Synucleinopathies are a group of rare diseases associated with worsening neurological deficits and the abnormal accumulation of the protein α-synuclein in the nervous system. Onset is usually in late adulthood at age 50 or older. Usually, synucleinopathies present clinically with slowness of movement, coordination difficulties or mild cognitive impairment. Development of these features indicates that abnormal alpha-synuclein deposits have destroyed key areas of the brain involved in the control of movement or cognition. Patients with synucleinopathies and signs of CNS-deficits are frequently diagnosed with Parkinson disease (PD), dementia with Lewy bodies (DLB) or multiple system atrophy (MSA).\n\nHowever, accumulation of alpha-synuclein and death of nerve cells can also begin outside the brain in the autonomic nerves. In such cases, syncucleinopathies present first with symptoms of autonomic impairment (unexplained constipation, urinary difficulties, and sexual dysfunction). In rare cases, hypotension on standing (a disorder known as orthostatic hypotension) may be the only clinical finding. This \"pre-motor\" autonomic stage suggests that the disease process may not yet have spread to the brain.\n\nAfter a variable period of time, but usually within 5-years, most patients with abnormally low blood pressure on standing develop cognitive or motor abnormalities. This stepwise evolution indicates that the disease spreads from the body to the brain. Another indication of this spread is that acting out dreams (i.e., REM sleep behavior disorder, RBD) a problem that occurs when the lower part of the brain is affected, may also be the first noticeable sign of Parkinson disease.\n\nThe purpose of this study is to document the clinical features and biological markers of patients with synucleinopathies and better understand how these disorders evolve over time. The study will involve following patients diagnosed with a synucleinopathy (PD\u002FDLB and MSA) and those believed to be in the \"pre-motor\" stage (with isolated autonomic impairment and\u002For RBD). Through a careful series of follow-up visits to participating Centers, we will focus on finding biological clues that predict which patients will develop motor\u002Fcognitive problems and which ones have the resilience to keep the disease at bay preventing spread to the brain. We will also define the natural history of MSA - the most aggressive of the synucleinopathies.",[84,85,86,27,87,88,89,90],"Patients With Synucleinopathies","Neurogenic Orthostatic Hypotension","Pure Autonomic Failure","Parkinson Disease","Dementia With Lewy Bodies","Multiple System Atrophy","Shy-Drager Disease",{"date":64,"type":34},{"date":93,"type":34},"2011-06",{"date":95,"type":21},"2026-12-30",{"name":97,"class":41},"NYU Langone Health",8,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":50,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":71},"100536858","the-cosp-rbd-study-concussions-and-contact-sports-in-rbd-vs-controls-100536858","NCT06270290","The COSP-RBD Study: Concussions and Contact Sports in RBD vs Controls","Observational Cross-sectional Study Investigating the History of Concussion and Exposure to Contact Sports in Patients With REM Sleep Behaviour Disorder (RBD) Versus Controls (Without a Diagnosis of RBD)","COSP-RBD","Inclusion criteria group with RBD:\n\n* Patient at the SDC with diagnosis of RBD (Guy's and St Thomas' NHS Foundation Trust).\n* 50 years of age or above (patients below this age would not be expected to have a RBD related to a synucleinopathy and other causes of RBD would need to be considered instead - e.g. narcolepsy, post-traumatic stress disorder).\n\nInclusion criteria control group:\n\n* Patients who have undergone a v-PSG at the SDC (Guy's and St Thomas' NHS Foundation Trust) and who do not have history of suspected RBD or RBD confirmed by v-PSG.\n* 50 years of age or above This group will be age- and sex-matched to the RBD group.\n\nExclusion criteria group with RBD:\n\n* Age \\\u003C 50 years of age.\n* Diagnoses of narcolepsy or post-traumatic stress disorder.\n* Subjects lacking capacity or literacy.\n* Non-English speakers.\n\nExclusion criteria control group:\n\n* Age \\\u003C 50 years of age (in order to match RBD group).\n* REM sleep without atonia or confirmed RBD on v-PSG.\n* Diagnosis of neurological diseases, cognitive complaints or motor complaints.\n* Clinical history suggestive of parasomnia that may be included in the differential of RBD.\n* Subjects lacking capacity or literacy.\n* Non-English speakers.",{"count":108,"type":21},140,"The goal of this observational study is to investigate concussions and contact sports practices in REM sleep behaviour disorder (RBD).\n\nThe main questions it aims to answer are:\n\n* What is the proportion of patients with RBD that have a history of concussions or exposure to contact sports?\n* Is this proportion higher to that in control patients without a diagnosis of RBD?\n\nParticipants will undergo an interview with a sleep medicine specialist to answer questions about history of concussions and contact sports practices.\n\nResearchers will compare an RBD group and a control group (without RBD) to see if the proportion of concussions and exposure to contact sports differ.",[27,111],"Concussion, Brain",[113,114,115],"REM sleep behaviour disorder","concussion","contact sports","2026-06-03",{"date":118,"type":34},"2026-06-04",{"date":120,"type":34},"2024-04-23",{"date":122,"type":21},"2026-09-30",{"name":124,"class":41},"Guy's and St Thomas' NHS Foundation Trust",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":50,"sex":16,"minAge":78,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":71},"100541406","intestinal-immunity-in-neurologic-disease-100541406","NCT06329453","Intestinal Immunity in Neurologic Disease","Inclusion Criteria:\n\n* Age 18 and up\n\nONE of the following:\n\n* Recommended to under a screening colonoscopy (+\u002F- upper endoscopy) as part of standard of care. This includes healthy individuals as well as those with neurologic and\u002For autoimmune diseases. OR\n* Willing to undergo research colonoscopy (+\u002F- upper endoscopy) for research\n\nExclusion Criteria:\n\n* Currently pregnant. Women of childbearing potential would perform a point of care urine pregnancy test prior to colonoscopy\u002Fendoscopy.\n* Known or suspected, chronic inflammatory gastrointestinal disease (e.g. inflammatory bowel disease)\n* Known, acute or chronic infections\n* Systemic antibiotic (PO or IV) use within 3 months of colonoscopy\n* Systemic corticosteroid use (equivalent of prednisone 10 mg per day or higher for \\>5 days) within 2 weeks of colonoscopy\n* Malignancy, diagnosed or treated within the last 5 years\n* Probiotic use within 2 weeks of procedure\n* History of major GI surgery (e.g. colon resection, gastric bypass)\n* Bleeding disorder, or on anticoagulant medication\n* Other medical condition that, in the judgement of the investigator, would lead to higher-than-expected risks of biopsy\n* Allergy to MAC anesthesia or other drugs used pursuant to standard of care for biospecimen collection","99 Years",{"count":133,"type":21},100,"The purpose of this study is to ascertain the functional profiles of the immune cells within the gastrointestinal tract and to determine how these cells contribute to autoimmune and neurologic diseases.",[136,87,27],"Multiple Sclerosis","2026-05-22",{"date":139,"type":34},"2026-05-27",{"date":141,"type":34},"2022-08-02",{"date":143,"type":21},"2027-08-31",{"name":40,"class":41},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":50,"sex":16,"minAge":151,"maxAge":152,"enrollmentInfo":153,"targetDuration":155,"studyType":81,"phases":4,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":71},"100635527","a-multimodal-prospective-cohort-study-of-parkinsonism-100635527","NCT07553845","A Multimodal Prospective Cohort Study of Parkinsonism","Inclusion Criteria:\n\nFor participants with rapid eye movement sleep behavior disorder:\n\n* Meets the diagnostic criteria for rapid eye movement sleep behavior disorder established by the American Academy of Sleep Medicine\n* Chinese citizen\n* Age \\>30 years and \\\u003C80 years\n* Able to understand the study, show good compliance, and provide written informed consent personally or through a legal representative\n\nFor participants with Parkinsonism:\n\n* Meets the diagnostic criteria for Parkinsonism established by the International Parkinson and Movement Disorder Society\n* Chinese citizen\n* Age \\>30 years and \\\u003C80 years\n* Able to understand the study, show good compliance, and provide written informed consent personally or through a legal representative\n\nFor healthy controls:\n\n* No neurodegenerative disease, no history of head trauma or head surgery, no history of stroke, epilepsy, tumor, or psychiatric disease\n* No metal implants or cardiac pacemaker\n* No severe chronic disease or severe hepatic or renal insufficiency\n* Chinese citizen\n* Age \\>30 years and \\\u003C80 years\n* Education level of primary school or above\n* Able to understand the study, show good compliance, and provide written informed consent personally or through a legal representative\n\nExclusion Criteria:\n\n* Significant cognitive impairment (MMSE ≤23)\n* Unable to sign the informed consent form or unable to complete study procedures for other reasons\n* Any other condition that, in the opinion of the investigator, makes the participant unsuitable for this study","31 Years","79 Years",{"count":154,"type":21},640,"5 Years","This is a single-center, prospective, observational cohort study designed to investigate the progression and differential diagnosis of Parkinsonism using a multimodal approach. The study plans to enroll 400 patients with Parkinsonism, 120 patients with rapid eye movement sleep behavior disorder, and 120 healthy controls, with follow-up for 5 years.\n\nAssessments will include neuroimaging, clinical rating scales, biological samples, blood flow evaluation, neurophysiological testing, tremor analysis, and voice and video assessments. The study aims to characterize disease progression, explore factors associated with progression from rapid eye movement sleep behavior disorder to Parkinsonism, and improve the ability to distinguish among different Parkinsonian disorders.",[158,27],"Parkinsonism","2026-04-20",{"date":161,"type":34},"2026-04-28",{"date":163,"type":34},"2024-05-01",{"date":165,"type":21},"2029-05",{"name":167,"class":41},"Ruijin Hospital",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":177,"conditions":178,"keywords":180,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":98},"100631267","unmet-needs-among-patients-with-isolated-rem-sleep-behavior-disorder-irbd-and-their-significant-others-100631267","NCT07498452","Unmet Needs Among Patients With Isolated REM Sleep Behavior Disorder (iRBD) and Their Significant Others","Exploring Unmet Needs Among Patients With Isolated REM Sleep Behavior Disorder (iRBD) and Their Significant Others: A Multicenter Cross-Sectional Survey Study","Inclusion Criteria:\n\n* Patients diagnosed with iRBD according to the International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria.\n* Patients who have had a follow-up visit within the previous 12 months.\n* Patients who provide informed consent to participate in the study.\n* Partners\u002Ffamily members of patients with iRBD who accept to participate.\n\nExclusion Criteria:\n\n* Patients with RBD who have already phenoconverted to a neurodegenerative disorder.\n* Patients or partners\u002Ffamily members without access to an email address.",{"count":176,"type":21},150,"The goal of this observational study is to explore the unmet needs and the psychosocial impact of isolated REM Sleep Behavior Disorder (iRBD) on patients and their significant others. Isolated REM Sleep Behavior Disorder is a sleep disorder characterized by dream-enactment behaviors during REM sleep and is increasingly recognized as a prodromal condition associated with neurodegenerative diseases. Despite growing clinical attention, little is known about the informational, emotional, and practical needs experienced by patients and their caregivers.\n\nThe main questions this study aims to answer are:\n\nWhat are the main unmet informational, psychological, and clinical needs reported by patients with isolated REM Sleep Behavior Disorder?\n\nWhat are the main challenges and support needs experienced by their significant others or caregivers?\n\nHow does the diagnosis of iRBD affect quality of life, emotional well-being, and perceptions of future health risks for both patients and caregivers?\n\nThis is a multicenter cross-sectional observational study conducted in several sleep and movement disorders centers. The study aims to collect structured information directly from patients and their significant others in order to better understand their experiences, concerns, and expectations regarding the disease and its management.\n\nParticipants will be asked to:\n\ncomplete an online questionnaire about their experience with isolated REM Sleep Behavior Disorder, including perceived needs, access to information, and interactions with healthcare services;\n\nreport information about emotional well-being, quality of life, and concerns related to the possible future progression of the disorder;\n\ncaregivers or significant others will complete a parallel questionnaire focused on their experiences, caregiving burden, informational needs, and perceived support.\n\nThe information collected in this study will help clinicians and researchers better understand the real-world needs of individuals living with isolated REM Sleep Behavior Disorder and their families. The results may contribute to improving patient education, clinical care pathways, and support services for this population.",[27,179],"Isolated REM Sleep Behavior Disorder",[60,27,181,182,183],"Prodromal Parkinsonism","Patient Needs","Sleep Disorders","2026-03-25",{"date":186,"type":34},"2026-03-27",{"date":188,"type":34},"2025-05-06",{"date":190,"type":21},"2026-08",{"name":192,"class":41},"Universita di Verona",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":50,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":71},"100494725","implementing-a-national-biobank-of-pd-with-wgs-and-functional-assessment-of-polygenic-inheritance-by-ipsc-technology-100494725","NCT05721911","Implementing a National Biobank of PD With WGS and Functional Assessment of Polygenic Inheritance by iPSC Technology","Implementing a National Biobank of Genetic, Sporadic and Prodromic Parkinson's Disease With Whole Genome Analysis and Functional Assessment of Polygenic Inheritance by iPSC Technology","Inclusion Criteria PD patients:\n\n* Presence of at least 2 of the 4 cardinal signs (tremor, rigidity, bradykinesia, onset asymmetric) one of which must be tremor or bradykinesia;\n* Absence of atypical symptoms such as: i) early postural instability, freezing phenomena, cognitive impairment, hallucinations, pathological involuntary movements, vertical gaze paralysis; ii) confirmed causes of secondary parkinsonism (focal lesions, drugs, substances toxic);\n* Documented response to L-dopa or dopamine agonist use (or lack of adequate therapeutic attempt with L-dopa or dopamine agonists).\n\nInclusion Criteria RBD patients:\n\n• Subjects affected by idiopathic RBD that will be selected according to the most recent criteria international classification of sleep disorders (ICSD-3).\n\nExclusion Criteria:\n\n* pre-existing psychiatric conditions;\n* Neurodegenerative neurological diseases such as multiple sclerosis, lateral sclerosis amyotrophic, Alzheimer's, neuromuscular pathologies, epilepsy;\n* diagnosis of dementia;\n* depression;\n* prolonged intake of anxiolytics, antidepressants, antipsychotics, hypnotic drugs, cognitive stimulants",{"count":201,"type":21},230,"The genetic complexity and heterogeneity of the sporadic forms of Parkinson's disease (PD) are posing a formidable challenge to disentangle their direct molecular causes. To advance this research, we plan to coordinate our local biorepositories of PD biological specimens creating a standardized and integrated national resource. In this framework, we plan to collect more samples from additional sporadic PD cases and to extend the sampling to patients with REM sleep behavior disease. We plan a large campaign of whole genome sequencing including about 200 patients to identify rare genomic variants plausibly associated with these diseases. In addition, we will standardize the generation and quality control of iPSC lines to make available to the scientific community. Finally, we will combine iPSC technology and gene editing to functionally assess the relative impact of rare variants in coding regions inherited together as a polygenic trait previously identified in selected sporadic PD cases",[87,27],{"date":205,"type":34},"2026-03-30",{"date":207,"type":34},"2023-10-30",{"date":209,"type":21},"2026-12",{"name":211,"class":41},"IRCCS San Raffaele",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":220,"conditions":221,"keywords":224,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":71},"100550038","behavioral-treatment-for-nightmares-in-rem-sleep-behavior-disorder-100550038","NCT06441864","Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder","Inclusion Criteria:\n\n* Diagnosis of isolated RBD or RBD secondary to neurodegenerative disease\n* Age 18 or older\n* Speak, read, and write English\n* Live in the United States\n* Nightmare frequency ≥3 times per week\n* Disturbing Dream and Nightmare Severity Index score indicative of nightmare disorder\n* Sleep, neurological, and psychiatric medications stable for at least 1 month and willing to keep medications stable through the course of the study\n* Live with a family member who is willing to participate in the study\n\nExclusion Criteria:\n\n* Possible dementia\n* Narcolepsy\n* Posttraumatic stress disorder\n* Previous behavioral treatment for nightmares\n* Currently engaged in sleep- or trauma-focused psychotherapy\n* Taking a medication that could cause RBD, if the medication was started prior to onset of RBD symptoms\n\nInclusion Criteria (Family Members):\n\n* Live with a family member who meets all of the above criteria\n* Age 18 or older\n* Speak, read, and write English\n* Live in the United States",{"count":42,"type":21},[56],"The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD). People with RBD will be enrolled in the study along with their family members (a partner or other family member residing in the same home). All participants will receive the treatment via videoconference and will complete 2 assessments. Participants with RBD will attend 7 sessions, and their family members will attend 2 of those sessions with them.",[222,223,27],"Nightmare","Nightmare Disorder With Associated Other Sleep Disorder",[225,226],"Imagery Rehearsal Therapy","Cognitive Behavioral Therapy for Nightmares","2026-03-09",{"date":229,"type":34},"2026-03-12",{"date":231,"type":34},"2024-07-15",{"date":233,"type":21},"2026-12-01",{"name":235,"class":41},"University of Utah",{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":50,"sex":16,"minAge":78,"maxAge":52,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":71},"100552005","identification-of-prodromal-neurodegeneration-in-serotonergic-induced-rem-sleep-behavior-disorder-100552005","NCT06467461","Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder","Inclusion Criteria:\n\nSerotonergic REM sleep behavior (5-HT RBD) participants\n\nInclusion Criteria:\n\n* Diagnosis of polysomnogram-confirmed RBD with history of dream enactment or clear dream enactment visualized on video from polysomnogram.\n* History of dream enactment began shortly after (less than 2 months) starting a serotonergic antidepressant medication. Control Participants\n\nInclusion Criteria:\n\n* Age (±3 years) and sex matched to participants with 5-HT RBD\n* On serotonergic medication for at least 6 months without history of dream enactment.\n\nThe following serotonergic medications will be included:\n\nCitalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, and Sertraline\n\nExclusion Criteria:\n\nSerotonergic REM sleep behavior (5-HT RBD) participants\n\nExclusion Criteria:\n\n* Younger than 18\n* Older than 75\n* Meet criteria for Parkinson's disease, dementia with Lewy bodies, Multiple System Atrophy, Pure Autonomic Failure, Alzheimer's disease, other diagnosed neurodegenerative disorder, or other known cause of RBD (e.g. narcolepsy)\n* Untreated obstructive sleep apnea, obesity hypoventilation, central sleep apnea or other sleep disordered breathing\n* History of dysarthria, aphasia or other condition which could interfere with speech assessment\n* Reduced capacity to consent\n* MRI exclusion criteria for 7T scans: presence of any metallic clip(s) or implantable medical devices (e.g., heart valve, aneurysm clip, coils or surgery, renal or aortic clips, shunts, stents or stent grafts, metal mesh\u002Fcoil implants, neurostimulator, insulin pump, IVC filter, etc.).\n* History of allergic response to xylocaine or other local anesthesia\n* Pregnant women will be excluded due to unknown risk of MRI on developing fetus Control Participants\n\nExclusion Criteria: same exclusion criteria as 5-HT RBD group, plus the following:\n\n* History of dream enactment that may suggest RBD\n* Increased REM motor tone (REM atonia index \\> 0.10) on PSG suggestive of RBD",{"count":243,"type":21},60,[56],"This project will test the hypotheses that people with 5-HT RBD have systemic alpha- synuclein pathology, prodromal DLB signs, and brainstem lesions in regions that control REM sleep. AIM 1 will seek to detect abnormally phosphorylated alpha- synuclein aggregates on targeted skin biopsy in a cohort of people with 5-HT RBD and matched controls (taking SSRIs but without RBD). Aim 2 will use ultra-high field MRI at 7T to examine the pontine region of the coeruleus\u002Fsubcoeruleus complex for evidence of neurodegeneration as well as segment and parcellate REM sleep related neuronal structures. Aim 3 will test for speech deficits. While these aims are independent we suspect that the severity of autonomic, speech and cognitive deficits will correlate with loss of neuromelanin signal on MRI and pathology on skin biopsy.\n\nThe investigation is a longitudinal designed study to examine histopathology, neuroimaging changes and speech function from baseline (Time 1) to a follow-up after 30 months (Time 2). A total of 60 individuals, 30 with 5-HT RBD and 30 controls, will be recruited at Time 1, brought back at Time 2, and tested across all Aims at both study visits.",[88,87,27],"2025-07-06",{"date":249,"type":34},"2025-07-08",{"date":251,"type":34},"2024-02-08",{"date":253,"type":21},"2028-09-01",{"name":70,"class":41},{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":22,"phases":264,"briefSummary":265,"conditions":266,"keywords":276,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":71},"100530935","slow-speed-nl-slowing-parkinsons-early-through-exercise-dosage-netherlands-100530935","NCT06193252","Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands","Slow-SPEED-NL","Inclusion Criteria:\n\n* previously diagnosed with iRBD meeting the following criteria according to the International Classification of Sleep Disorders (ICSD-3)\n* able to understand the Dutch language\n* being able to walk independently inside the home without the use of a walking aid\n* Not in a high physical activity range during the 4-week eligibility and baseline period\n* in possession of a suitable smartphone compatible with the Slow-SPEED app, the Fitbit app and the Roche PD Research Mobile application.\n\nExclusion Criteria:\n\n* clinically diagnosed or self-reported diagnosis neurodegenerative disease;\n* self-reported weekly falls in the previous 3 months;\n* dexterity problems or cognitive impairments hampering smartphone use;\n* if they do not wish to be informed about an increased risk of developing diseases associated with iRBD\n* if individual is not community-dwelling\n\nExclusion criteria for MRI only:\n\n* history of epilepsy, structural brain abnormalities (i.e. stroke, traumatic defects, large arachnoid cysts) or brain surgery\n* claustrophobia\n* implanted electrical devices (i.e. pacemaker, deep-brain stimulator (DBS), neurostimulator)\n* metal implants (such as prosthetics, ossicle prosthesis, metal plates or other non-removable metal part) or metal splinters\n* pregnancy\n* fear for incidental finding",{"count":263,"type":21},110,[56],"The goal of this clinical trial is to investigate the feasibility if a remotely administered smartphone app can increase the volume and intensity of physical activity in daily life in patients with isolated Rapid Eye Movement (REM) sleep behaviour disorder over a long period of time (24 months).\n\nParticipants will be tasked to achieve an incremental increase of daily steps (volume) and amount of minutes exercised at a certain heart rate (intensity) with respect to their own baseline level. Motivation with regards to physical activity will entirely be communicated through the study specific Slow Speed smartphone app. Primary outcomes will be compliance expressed as longitudinal change in digital measures of physical activity (step count) measured using a Fitbit smartwatch. Exploratory outcomes entail retention rate, completeness of remote digital biomarker assessments, digital prodromal motor and non-motor features of PD, blood biomarkers and brain imaging markers. Using these biomarkers, we aim to develop a composite score (prodromal load score) to estimate the total prodromal load. An international exercise study with fellow researchers in the United States and United Kingdom are currently in preparation (Slow-SPEED). Our intention is to analyse overlapping outcomes combined where possible through a meta-analysis plan, to obtain insight on (determinants of) heterogeneity in compliance and possible efficacy across subgroups",[87,267,268,269,27,270,271,272,273,274,275],"Prodromal Stage","Neurodegenerative Diseases","Parkinsonian Disorders","Basal Ganglia Diseases","Central Nervous System Diseases","Synucleinopathies","Nervous System Diseases","Cerebral Disorder","Brain Diseases",[277,278,279,280,281,282,283,284,285,286,287,288,87,289],"Physical Activity","Prevention","Remote","Mobile Health (mHealth)","Feasibility","Exercise","Digital biomarker","Blood","Imaging","MRI","Motivational application","Walking","Prodromal","2025-05-28",{"date":292,"type":34},"2025-06-03",{"date":294,"type":34},"2024-01-15",{"date":296,"type":21},"2027-12-01",{"name":298,"class":41},"Radboud University Medical Center",{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":50,"sex":16,"minAge":78,"maxAge":306,"enrollmentInfo":307,"targetDuration":4,"studyType":22,"phases":308,"briefSummary":310,"conditions":311,"keywords":348,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":71},"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.","65 Years",{"count":133,"type":21},[309],"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.",[312,313,314,27,315,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345,346,347],"Chronic Insomnia","Sleep Deprivation","REM 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","Idiopathic Hypersomnia","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",[349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,316,313,367,323,368,336,331,329,330],"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","IH","Sleep Debt","2025-05-27",{"date":290,"type":34},{"date":372,"type":21},"2025-11-01",{"date":374,"type":21},"2026-05-01",{"name":361,"class":376},"INDUSTRY",{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":11,"sex":16,"minAge":383,"maxAge":52,"enrollmentInfo":384,"targetDuration":4,"studyType":22,"phases":385,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":71},"100577360","the-impact-of-light-electrical-and-magnetic-neuroregulation-interventions-on-sleep-wake-disorders-100577360","NCT06797284","The Impact of Light, Electrical, and Magnetic Neuroregulation Interventions on Sleep-wake Disorders","Inclusion Criteria:\n\n\\- Patients with insomnia, narcolepsy,and RBD that have been clearly diagnosed by specialists should sign the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with major neurological diseases such as multi-infarct dementia, Huntington\\'s disease, normal pressure hydrocephalus, brain tumors, progressive supranuclear palsy, epilepsy, subdural hematoma, multiple sclerosis, or those who have sustained neurological dysfunction or known structural brain abnormalities after significant head trauma are excluded.\n2. A history of major depressive disorder or bipolar disorder within the past year, as defined in DSM-IV criteria. A history of schizophrenia (meeting DSM-IV criteria).\n3. History of severe drug or alcohol abuse within the past year;\n4. Any significant systemic illness or unstable medical condition that may make it difficult to comply with the protocol, such as severe autoimmune diseases or a history of cancer.\n5. Have significant hearing, visual, or cognitive impairments, or are unable to participate in interviews in a meaningful way.","8 Years",{"count":42,"type":21},[56],"Carry out precise and effective neuromodulation interventions, and develop new neuromodulation technologies for sleep disorders. Use phototherapy, transcranial electrical\u002Fmagnetic stimulation and other therapies to conduct self-controlled intervention studies on insomnia, narcolepsy, and rapid eye movement sleep behavior disorder .",[388,389,27],"Insomnia Chronic","Narcolepsy","2025-02-11",{"date":392,"type":34},"2025-02-14",{"date":394,"type":34},"2025-02-01",{"date":396,"type":21},"2026-12-31",{"name":398,"class":41},"Second Affiliated Hospital of Soochow University",{"id":400,"slug":401,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":22,"phases":408,"briefSummary":409,"conditions":410,"keywords":412,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":71},"100564440","artificial-intelligence-in-molecular-imaging-predicting-parkinsons-risk-in-rem-sleep-behavior-disorder-100564440","NCT06629207","Artificial Intelligence in Molecular Imaging: Predicting Parkinson's Risk in REM Sleep Behavior Disorder","Artificial Intelligence on Molecular Imaging to Predict the Risks of Parkinson's Disease for Patients With Rapid Eye Movement Sleep Behavior Disorder","NUK-RBD","Inclusion Criteria:\n\n1. Confirmed clinical iRBD diagnosis by movement disorder specialists according to the International Classification of Sleep Disorders\n2. Written informed consent\n\nExclusion Criteria:\n\n1. Known diagnosis of PD or other neurodegenerative disorder\n2. Unequivocal signs of parkinsonism on examination\n3. Narcolepsy or other known causes of RBD\n4. Moderate to severe obstructive sleep apnea\n5. Abnormal neurological or MRI examination",{"count":42,"type":21},[56],"The study aims to systematically document the course of REM sleep behavior disorder (RBD) and investigate possible clinical and imaging biomarkers for disease progression and conversion risk to Parkinson's disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA). The study will use artificial intelligence to analyze imaging and develop a reliable method to predict and stratify patients approaching conversion to overt a-synucleinopathy. Participants will be clinically evaluated and 2 imaging procedures will be done.",[87,27,411],"Dementia, Lewy Body",[87,413,27],"Artificial Intelligence","2024-11-07",{"date":416,"type":34},"2024-11-08",{"date":418,"type":34},"2024-10-07",{"date":420,"type":21},"2026-08-01",{"name":422,"class":41},"Insel Gruppe AG, University Hospital Bern",{"id":424,"slug":425,"hasResults":11,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":433,"conditions":434,"keywords":435,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":447},"100459432","predictive-risk-factors-of-conversion-into-idiopathic-rbd-italian-study-100459432","NCT05262543","PREdictive Risk Factors of Conversion Into Idiopathic RBD. Italian Study","Redictive Risk Factors of Conversion Into Idiopathic RBD. Italian Study [FAttori di Rischio PREdittivi di Conversione Nell'RBD Idiopatico. STudio ItalianO","FARPRESTO","Inclusion Criteria:\n\n* Age: major of 18 years old\n* iRBD diagnosis, according to diagnostic criteria of the ICSD second and third edition\n\nExclusion Criteria:\n\n* Impossibility to provide or withdraw informed consent and inability to read, write and understand the purpose and modality of the study.",{"count":432,"type":21},300,"REM Sleep Behavior Disorder (RBD) is a REM sleep parasomnia first described in 1986 and characterized by the loss of physiological muscle atonia typical of REM sleep and by the presence of abnormal, sometimes violent, motor activity often related to dream content The observed motor behaviors are often associated to vivid dreams, characterized by an aggressive-defensive content, even if pleasant dreams have been described, resulting in non-violent behaviors. Diagnosis of RBD requires video-polysomnographic recording (vPSG) at a Sleep Center, essential to identify and quantify the complete or intermittent loss of physiological muscle atonia during REM sleep (REM sleep without atonia, RSWA) and record any related motor behaviors. The exact prevalence of RBD in the general population is not known and it seems underrated, but is estimated to be 0.3-1.15%. RBD is defined as idiopathic or isolated (iRBD) when it is not associated with other neurological diseases. The so-called symptomatic RBD, on the other hand, can occur in association with neurodegenerative diseases of the spectrum of alpha-synucleinopathies which include Parkinson's Disease (PD), Multiple System Atrophy (AMS), and Lewy Body Dementia (DLB). In recent years, several follow-up studies on large cohorts of iRBD patients have shown that the idiopathic form evolves towards a symptomatic form in most cases. More precisely, the risk of developing an alpha-synucleinopathies increases over time, with a conversion rate of up to 90% in some studies at 14 years. RBD represents an early marker of neurodegeneration, like a unique open window on the initial, pre-symptomatic phase of alpha-synucleinopathies, which could allow the use of neuroprotective therapies, as soon as they are available. Several longitudinal studies indicated older age, presence of hyposmia, abnormal color vision, minimal extrapyramidal motor signs, mild cognitive impairment, autonomic disturbances, and severity of loss of RSWA as risk factors for neurodegeneration. However, most studies investigated biomarkers separately, with retrospective study designs, in small cohorts or without a rigorous harmonization between centers in the case of multicenter studies.\n\nTo date, however, there is no reliable pool of biomarkers that predict the phenoconversion into α-synucleinopathy, the timing in which this can occur, and the phenotype of α-synucleinopathy. Furthermore, despite clinical and research evidence suggesting that iRBD is a heterogeneous disorder little attention was paid to different iRBD phenotypes and currently, there are no relevant data on the impact of iRBD on quality of life.\n\nActually, through neural network analysis approaches, it is possible to find out complex correlations between data from different sources (i.e., clinical examinations, questionnaires, biological data, imaging and neurophysiological techniques, etc.) and to identify subgroups of patients sharing the same substantial characteristics. Identifying different iRBD phenotypes through established as well as innovative biomarkers and standardized measures of wellbeing is crucial to better understanding alpha-synucleinopathies, developing targeted interventions, and reducing the disease burden.\n\nTo this aim, clinical, biological, neurophysiological, neuropsychological and imaging biomarkers need to be prospectively collected, according to standardized and harmonized procedures. This would significantly increase our understanding of the physiopathological processes of alpha-synucleinopathy from the prodromal phase. Indeed, identifying phenotype clusters with both consolidated and innovative biomarkers may lay the groundwork for a reliable characterization of iRBD patients, likely providing the basis for an efficient stratification of patients longitudinally followed.\n\nSeveral disease-modifying therapies are now in development, including but not limited to monoclonal antibodies against alpha-synucleinopathy. Prodromal synucleinopathy patients, such as those with iRBD, are the ideal target to test disease-modifying therapies because the neurodegeneration is still in an early stage and the likelihood to rescue both brain structures and function is higher. The last aim of the FarPResto study is to have a trial-ready cohort of iRBD patients, collected with standardized and harmonized procedures, to be enrolled in upcoming disease-modifying trials.\n\nThe FARPRESTO project is endorsed by the Italian Association of Sleep Medicine (AIMS) and by The RBD\\_Patients society (www.sonnomed.it)",[27],[436,437],"atonia","neurodegeneration","2024-03-22",{"date":440,"type":34},"2024-03-26",{"date":442,"type":34},"2020-05-25",{"date":444,"type":21},"2035-01-31",{"name":446,"class":41},"University of Cagliari",2]