[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"parkinsons\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:parkinsons":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,72,92,109],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100267656","investigations-of-dementia-in-parkinson-disease-100267656",false,"NCT02763683","Investigations of Dementia in Parkinson Disease","PIB","Inclusion Criteria:\n\n* PD patients must exhibit three of the following cardinal signs: rest tremor, rigidity, bradykinesia, or postural instability; or two of these features with one of the first three displaying asymmetry.\n\nExclusion Criteria:\n\n* history of head trauma, major neurological or psychiatric diseases other than Parkinson disease and dementia, e.g. stroke, multiple sclerosis, depression or schizophrenia.\n* severe systemic diseases.\n* inability to lie still for 90 minutes.\n* metallic implants, pacemakers, or any other contraindication to MRI.\n* refusal to consent to brain donation.",true,"ALL","50 Years",{"count":20,"type":21},320,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to use a brain imaging method called Pittsburgh B (PIB) Positron Emission Tomography (PET) and Vesicular Cholinergic Transport (VAT) PET to determine dementia subtypes in patients with Parkinson disease (PD). The ultimate goal of this project is to be able to identify individuals with PD who are at risk of developing dementia, and to distinguish the underlying cause of dementia.",[25],"Parkinsons",[27,28,14,29,30],"Parkinsons Disease","PET Imaging","VAT","Dementia","RECRUITING","2026-05-06",{"date":34,"type":35},"2026-05-08","ACTUAL",{"date":37,"type":4},"2016-06",{"date":39,"type":21},"2030-03",{"name":41,"class":42},"Washington University School of Medicine","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":43},"100479102","molecular-and-functional-imaging-in-monogenic-pd-100479102","NCT05518617","Molecular and Functional Imaging in Monogenic PD.","Molecular and Functional Imaging of Parkinson's Pathology in SNCA, Parkin and PINK1 Mutation Carriers","FOX_1","Inclusion Criteria:\n\n* All subjects must be judged by the investigator able to understand the nature, design, and procedures of the study and must be able to provide a signed and dated informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.\n* All subjects must be willing and able to comply with scheduled visits, required study procedures and laboratory tests.\n* All subjects must be able to travel to the research sites for the study procedures.\n* For female subjects: They must be either of non-childbearing potential (either surgically sterile or post- menopausal - defined as 12 months of spontaneous amenorrhea), or, if of childbearing potential, subjects must demonstrate to be non-pregnant (as demonstrated by negative urine β-HCG test at screening), non-breastfeeding.\n* All subjects must comply with highly effective contraceptive measures. A highly effective contraceptive measure is defined as a measure that can achieve a failure rate of less than 1% per year when used consistently and correctly. These methods are listed in more detail below:\n\nOral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation;\n\nOral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation:\n\nIntrauterine device (IUD)\n\nIntrauterine hormone-releasing system (IUS)\n\nBilateral tubal occlusion\n\nVasectomised partner\n\nSexual abstinence\n\n* For sexually active male subjects, they must agree to use condoms to protect their partners from becoming pregnant for the duration of the study and for 3 months after the last administration of PET or SPECT ligands. They must also agree to ensure that they and their partners are routinely using a medically approved contraceptive method. It is important that male subjects not impregnate others for the duration of the study and for 3 months after the last administration of PET or SPECT ligands.\n\n  \\*\\*All subjects must have adequate visual and auditory acuity according to investigator's judgement to complete the psychological testing.\n* All subjects must have no use of medications with known interaction with serotonergic transmission (e.g. selective serotonin reuptake inhibitors, tricyclic antidepressant, triptans, etc).\n* For subjects taking any drugs that might interfere with dopamine transporter SPECT imaging (neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative) must be willing and able from a medical standpoint to hold the medication for at least 5 half-lives prior to screening DaTSCANä imaging.\n\nExclusion Criteria:\n\n* Subjects lacking capacity according to investigator judgement.\n* Subjects with a clinical diagnosis of dementia as determined by the investigator.\n* Current treatment with anticoagulants (e.g. warfarin, heparin) that might preclude safe completion of the lumbar puncture.\n* Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.\n* Use of any of the following drugs that might interfere with dopamine transporter SPECT imaging: neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 5 months of Screening.\n* Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).\n* History of cancer within the last 5 years, with the exception of non-metastatic basal cell carcinoma of the skin.\n* Subjects with current or recent history of drug or alcohol abuse\u002Fdependence.\n* Contraindication to MRI, such as presence of metal devises or implants (e.g. pacemaker, vascular- or heart- valves, stents, clips), metal deposited in the body (e.g. bullets or shells), or metal grains in the eyes;\n* Claustrophobia or history of back pain that makes prolonged laying on the PET or MRI scanner intolerable.\n* Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).\n* Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.","25 Years","80 Years",{"count":55,"type":21},45,"In this study, the investigators aim to find a biomarker of Parkinson's disease. This is done using imaging scans called Positron Emission tomography (PET), Single Photon Emission Computed Tomography (SPECT), and Magnetic Resonance Imaging (MRI). The findings will provide a deeper understanding of the brain changes in Parkinson's disease. More importantly, this study will help with the discovery and development of new medications aiming to delay progression of PD symptoms.",[58,59,60,61,62],"Parkinson Disease","Nervous System Disorder","Neurodegenerative Diseases","Neurodegenerative Disease, Hereditary","Parkinson's","2025-10-01",{"date":65,"type":35},"2025-10-07",{"date":67,"type":35},"2022-07-01",{"date":69,"type":21},"2026-06-30",{"name":71,"class":42},"University of Exeter",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":91,"locationsCount":43},"100478957","serotonin-release-in-premotor-and-motor-pd-100478957","NCT05516732","Serotonin Release in Premotor and Motor PD","Evaluation of Serotonergic Neurotransmission in Premotor and Motor Parkinson's Disease.","FOX3","Inclusion criteria-\n\n* Subjects must understand the nature of the study and must provide signed and dated written HRA-approved informed consent in accordance with local regulations before any protocol-specific screening procedures are performed;\n* Males and females, age 25-85 years, inclusive;\n* Women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative β-hCG test at screening. For sexually active subjects (except females of non-childbearing potential-e.g., at least 2 years postmenopausal or surgically sterile), condoms should be used in addition to other birth control methods for the duration of the study and for 3 months after the last administration of PET or SPECT ligands. These patients must be willing to remain on their current form of contraception for the duration of the study. All male subjects must agree to refrain from donating sperm for the duration of the study and for 3 months after the last administration of PET or SPECT ligands. Sexually active male subjects must agree to use condoms to protect their partners from becoming pregnant for the duration of the study and for 3 months after the last administration of PET or SPECT ligands (i.e. for 15 consecutive months following baseline PET and SPECT scans); agree to ensure that they and their partners are routinely using a medically approved contraceptive method. It is important that male subjects not impregnate others for the duration of the study and for 3 months after the last administration of PET or SPECT ligands;\n* Able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete all required tests and procedures;\n* Adequate visual and auditory acuity to complete the psychological testing;\n* In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.\n\nExclusion criteria -\n\n* Subjects lacking capacity according to investigator judgement;\n* Subjects taking serotonin acting drugs such as antidepressants (i.e. tricyclic or selective serotonin reuptake inhibitors etc.);\n* Pregnancy or breastfeeding or intent to become pregnant in the next 18 months;\n* Subjects with current or a recent history of drug or alcohol abuse\u002Fdependence;\n* Subjects who have other neurological disorders and known intracranial co-morbidities such as stroke, hemorrhage, space-occupying lesions;\n* Presence of any clinically significant medical condition (including cardiovascular, respiratory, cerebrovascular, hematological, hepatic, renal, gastrointestinal, or other disease) that, based on the judgment of the investigator, is clinically unstable, is likely to deteriorate during the course of the study, could put the patient at risk because of participation in the study, could affect the subject's ability to complete the study, or could influence the study results;\n* History of suicidal behaviour or active suicidal ideation;\n* Within 1 year prior to screen or between screen and baseline (Day -1), any of the following: myocardial infarction; hospitalization for congestive heart failure; hospitalization for, or symptoms of, unstable angina; or syncope not related to PD;\n* History or presence of renal disease or impaired renal function;\n* Clinically important infection (e.g., chronic, persistent, or acute infection) within 30 days prior to screen or between screen and baseline (Day -1);\n* History of cancer within the last 5 years, with the exception of nonmetastatic basal cell carcinoma of the skin;\n* Clinically significant blood clotting or bleeding disorder, including clinically significant abnormal findings in laboratory assessments of coagulation or hematology;\n* Use of antipsychotic medication within 3 months prior to screen or between screen and baseline (Day -1);\n* Use of any anticoagulant within 30 days prior to baseline and follow-up PET scans;\n* Use of any oral corticosteroid within 30 days prior to baseline and follow-up PET scans;\n* Use of metoclopramide within 30 days prior to baseline and follow-up (Day -1);\n* Use of any thyroid medication within 30 days prior to baseline and follow-up (Day -1);\n* Regular use (e.g., taken \\> 3 days\u002Fweek) of narcotic pain medications within 30 days prior to baseline and follow-up (Day -1);\n* Presence of any of the following MRI contraindications: pacemaker; cardiac defibrillator; spinal cord or vagus nerve stimulator; aneurysm clip; artificial heart valve; recent coronary or carotid stent; ear implant; CSF shunt; other implanted medical device (e.g., Swan-Ganz catheter, insulin pump); or metal fragments or foreign objects in the eyes, skin, or body;\n* Negative modified Allen test in both hands, unless the brachial artery is used for arterial cannulation;\n* Claustrophobia or history of back pain that makes prolonged laying on the PET or MRI scanner intolerable;\n* History of severe skin allergy;\n* Patients who had previous surgery for PD (including but not limited to deep brain stimulation \\[DBS\\] or cell transplantation);\n* Patients who are treated with duodopa or apomorphine;\n* Initiation or change in pharmacologic therapy for symptoms of PD within 30 days prior to screen or between screen and baseline and follow-up (Day -1).\n* GDS score greater than or equal to 10 (GDS score of 5 - 9 requires Investigator discretion to enter study).\n* STAI Form Y-1 greater than or equal to 54 requires Investigator discretion to enter study.","85 Years",{"count":82,"type":21},42,"In this study, the investigators aim to provide a deeper understanding of Parkinson's disease and find a biomarker of Parkinson's disease. This is done using imaging scans called Positron Emission tomography (PET), Single Photon Emission Computed Tomography (SPECT), and Magnetic Resonance Imaging (MRI). The findings will provide a deeper understanding of the brain changes in Parkinson's disease. More importantly, this study will help with the discovery and development of new medications aiming to delay progression of Parkinson's disease symptoms",[58,62,85,60,86,87],"Parkinson's Disease","Neurodegeneration","Positron Emission Tomography",{"date":65,"type":35},{"date":67,"type":35},{"date":69,"type":21},{"name":71,"class":42},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":16,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":108,"locationsCount":43},"100478956","longitudinal-investigation-of-i2bs-in-pd-100478956","NCT05516719","Longitudinal Investigation of I2BS in PD","Longitudinal Investigation of Imidazoline-2 Binding Site as a Novel Marker of Disease Progression in Parkinson's Disease: An [11C]BU99008 PET Study","FOX_2","Inclusion criteria\n\n* All subjects must be judged by the investigator able to understand the nature, design, and procedures of the study and must be able to provide a signed and dated informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.\n* All subjects must be willing and able to comply with scheduled visits, required study procedures and laboratory tests.\n* All subjects must be able to travel to the research sites for the study procedures.\n* Age 25 years or older.\n* For female subjects: They must be either of non-childbearing potential (either surgically sterile or post- menopausal - defined as 12 months of spontaneous amenorrhea), or, if of childbearing potential, subjects must demonstrate to be non-pregnant (as demonstrated by negative urine β-HCG test at screening), non-breastfeeding.\n* All subjects must comply with highly effective contraceptive measures. A highly effective contraceptive measure is defined as a measure that can achieve a failure rate of less than 1% per year when used consistently and correctly. These methods are listed in more detail below:\n\nOral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation;\n\nOral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation:\n\nIntrauterine device (IUD)\n\nIntrauterine hormone-releasing system (IUS)\n\nBilateral tubal occlusion\n\nVasectomised partner\n\nSexual abstinence\n\n* For sexually active male subjects, they must agree to use condoms to protect their partners from becoming pregnant for the duration of the study and for 3 months after the last administration of PET or SPECT ligands. They must also agree to ensure that they and their partners are routinely using a medically approved contraceptive method. It is important that male subjects not impregnate others for the duration of the study and for 3 months after the last administration of PET or SPECT ligands.\n* All subjects must have adequate visual and auditory acuity according to investigator's judgement to complete the psychological testing.\n* All subjects must have no use of medications with known interaction with I2BS (e.g. idaxozan, efaroxan, yohimbine, atomoxetine, atipamezole, mianserin, mirtazapine, clonidine, guanfacine, guanabenz, guanethidine, xylazine, tizanidine, tedetomidine, methyldopa, fadolmidine, dexmedetomidine)\n* For subjects taking any drugs that might interfere with dopamine transporter SPECT imaging (neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative) must be willing and able from a medical standpoint to hold the medication for at least 5 half-lives prior to screening DaTSCANä imaging.\n\nExclusion criteria\n\n* Subjects lacking capacity according to investigator's judgment;\n* Subjects with a clinical diagnosis of dementia as determined by the investigator;\n* Subjects with current or a recent history of drug or alcohol abuse\u002Fdependence;\n* Current treatment with anticoagulants (e.g. warfarin, heparin) that might preclude the arterial cannulation and the safe completion of the lumbar puncture.\n* Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.\n* Negative Allen test in both hands,\n* Use of any of the following drugs that might interfere with dopamine transporter SPECT imaging: neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 5 months of Screening.\n* Use of any medications with known actions on I2BS (e.g. idaxozan, efaroxan, yohimbine, atomoxetine, atipamezole, mianserin, mirtazapine, clonidine, guanfacine, guanabenz, guanethidine, xylazine, tizanidine, tedetomidine, methyldopa, fadolmidine, dexmedetomidine);\n* Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).\n* History of cancer within the last 5 years, with the exception of non-metastatic basal cell carcinoma of the skin.\n* Subjects with current or recent history of drug or alcohol abuse\u002Fdependence.\n* Contraindication to MRI, such as presence of metal devises or implants (e.g. pacemaker, vascular- or heart- valves, stents, clips), metal deposited in the body (e.g. bullets or shells), or metal grains in the eyes;\n* Claustrophobia or history of back pain that makes prolonged laying on the PET, SPECT, or MRI scanner intolerable.\n* Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).\n* Presence of any clinically significant medical condition (including cardiovascular, respiratory, cerebrovascular, hematological, hepatic, renal, gastrointestinal, or other disease) that, based on the judgment of the investigator, is clinically unstable, is likely to deteriorate during the course of the study, could put the patient at risk because of participation in the study, could affect the subject's ability to complete the study, or could influence the study results;\n* History of suicidal behavior or active suicidal ideation;\n* Pregnancy or breastfeeding or intent to become pregnant in the next 18 months;",{"count":101,"type":21},44,"In this study, the researchers aim to find a biomarker of PD. Using imaging scans called Positron Emission tomography (PET), Single Photon Emission Computed Tomography (SPECT), and Magnetic Resonance Imaging (MRI). The PET and SPECT scans use small amounts of radiation and specific compounds called tracers, to study chemical changes in the brain in a way not possible with any other procedure. The MRI uses magnetic fields to generate images of brain structure and function",[62,58,85,60,86,87],{"date":65,"type":35},{"date":106,"type":35},"2021-11-01",{"date":69,"type":21},{"name":71,"class":42},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":16,"sex":17,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":161,"overallStatus":182,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":43},"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.","18 Years","65 Years",{"count":119,"type":21},100,"INTERVENTIONAL",[122],"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.",[125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,25,147,148,149,150,151,152,153,154,155,156,157,158,159,160],"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","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","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",[162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,130,126,180,137,181,149,145,143,144],"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","NOT_YET_RECRUITING","2025-05-27",{"date":185,"type":35},"2025-05-28",{"date":187,"type":21},"2025-11-01",{"date":189,"type":21},"2026-05-01",{"name":174,"class":191},"INDUSTRY"]