11 completed, 1 active not recruiting, 1 not yet recruiting, 1 recruiting. 17 Phase 2, 3 Phase 1, 2 Phase 3.
Follow Sleep Disorder: new trials by email Literature Review of Sleep Disorder trials Research Report on Sleep Disorder
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of the Safety and Exploratory Efficacy of Oral AFA-281 in Patients with Alcohol Use Disorder AFA-281 - Alcohol Abuse, Alcohol Abuse/addiction | Phase 2 | Not yet recruiting | Afasci Inc | 36 | 2025-10-01 | 2024-11-29 |
| The Efficacy and Safty of FMT in Patients With CID fecal microbiota, Placebo, synbiotics - Insomnia Chronic, Fecal Microbiota Transplantation | Phase 1 / Phase 2 | Completed | Peking University Sixth Hospital | 80 | 2023-10-08 | 2026-02-27 |
| Cannabinoids as a Treatment for Insomnia in Major Depression 25:1 CBD/THC, 5:1 CBD/THC, Placebo - Insomnia, Depressive Disorder, Major | Phase 2 | Completed | St. Joseph's Healthcare Hamilton | 14 | 2023-08-28 | 2026-01-22 |
| Cerebral Blood Flow and Ventilatory Responses During Sleep in Normoxia and Intermittent Hypoxia Drug Lowering Cerebral Blood Flow (CBF) and Normoxia Sleep, Drug Lowering CBF and Intermittent Hypoxia Sleep, Placebo and Normoxia Sleep - Obstructive Sleep Apnea of Adult, Hypoxia, Brain | Phase 1 / Phase 2 | Recruiting | University of Calgary | 12 | 2023-01-01 | 2026-05-01 |
| Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD Pramipexole, Placebo - Sleep Disorder, Restless Legs Syndrome | Phase 2 / Phase 3 | Terminated | Massachusetts General Hospital | 75 | 2022-01-24 | 2025-09-22 |
| Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids Positive Airway Pressure (PAP) - Sleep Disorder; Breathing-Related, Pain | Phase 2 | Completed | University of California, San Diego | 62 | 2021-08-10 | 2024-12-02 |
| Effects of Experimental Sleep Disturbances on Receptor Function of Study Drug Sleep Fragmentation, Within-Subject test of blinded study medication (stimulant, benzodiazepine, opioid, cannabinoid, over-the-counter pain medication, or placebo), Sleep Continuity Disruption - Sleep Disorder, Healthy | Phase 2 | Completed | Johns Hopkins University | 148 | 2020-11-11 | 2025-09-24 |
| Do Endotypes Predict Response and Sequelae in OSA Patients Eszopiclone, Supplemental Oxygen, Continuous Positive Airway Pressure (CPAP) - Obstructive Sleep Apnea, Sleep Apnea | Phase 2 | Completed | University of California, San Diego | 233 | 2020-08-01 | 2026-06-18 |
| Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia Tesamorelin, Placebo - Sleep Disorder, Traumatic Brain Injury | Phase 2 | Withdrawn | National Institute of Nursing Research (NINR) | 2016-10-06 | 2019-11-19 | |
| Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer Counseling, Methylphenidate Hydrochloride, Phototherapy - Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm | Phase 2 | Active not recruiting | M.D. Anderson Cancer Center | 68 | 2014-01-15 | 2026-11-12 |
| Different Doses of Oral Melatonin Supplements in Chronic Kidney Disease (CKD)-Associated Sleep Disorders Melatonin - End Stage Renal Disease, Chronic Kidney Disease | Phase 2 / Phase 3 | Unknown | Southeast Renal Research Institute | 53 | 2012-12-01 | 2017-01-24 |
| Study of Sleep-maintenance Activity of 3 Doses of SKP-1041 placebo, SKP-1041 (experimental formulation of zaleplon) - Sleep Disorder, Primary Insomnia | Phase 2 | Completed | Somnus Therapeutics, Inc. | 67 | 2010-05-01 | 2013-02-01 |
| Efficacy of Circadin® 2 mg in Patients With Mild to Moderate Alzheimer Disease Treated With AChE Inhibitor Circadin, Placebo - Alzheimer's Disease, Sleep Disorder | Phase 2 | Completed | Neurim Pharmaceuticals Ltd. | 73 | 2009-09-01 | 2018-06-01 |
| Study of Istradefylline (KW-6002) for the Treatment of Restless Legs Syndrome Istradefylline (KW-6002) - Sleep Disorder, Restless Legs Syndrome | Phase 2 | Completed | Kyowa Kirin, Inc. | 160 | 2005-07-01 | 2024-04-25 |
| Better Days, Better Nights: Treatment for Sleep Difficulties (Telephone Coached) FHP Sleep Program - Sleep Disorder | Phase 2 | Completed | IWK Health Centre | 61 | 2005-04-01 | 2016-09-02 |
| Safety and Efficacy of Ramelteon in Healthy Subjects Ramelteon, Placebo - Sleep Disorder | Phase 2 | Completed | Takeda | 75 | 2005-03-01 | 2012-02-28 |
| Single Dose Pharmacokinetic and Pharmacodynamic Evaluation of Three Different Doses of Zolpidem in Children Zolpidem - Insomnia, Sleep Disorder | Phase 1 / Phase 2 | Completed | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | 63 | 2002-10-01 | 2007-06-29 |
Sleep Wake Disorders (17) · Sleep Initiation and Maintenance Disorders (6) · Sleep Apnea Syndromes (4) · Depression (3) · Anxiety Disorders (2) · Pain (2) · Parasomnias (2) · Restless Legs Syndrome (2) · Sleep Apnea, Obstructive (2) · Agnosia (1) · Alcoholism (1) · Alzheimer Disease (1) · Behavior, Addictive (1) · Brain Injuries, Traumatic (1) · Chronic Pain (1)
Mental Disorders (17) · Nervous System Diseases (17) · Neurologic Manifestations (17) · Pathological Conditions, Signs and Symptoms (17) · Signs and Symptoms (17) · Dyssomnias (12) · Sleep Disorders, Intrinsic (11) · Apnea (4) · Respiration Disorders (4) · Respiratory Tract Diseases (4) · Behavior (3) · Behavioral Symptoms (3) · Brain Diseases (3) · Central Nervous System Diseases (3) · Chemically-Induced Disorders (3)
Melatonin (3) · Analgesics, Opioid (1) · Benzodiazepines (1) · Cannabinoids (1) · Central Nervous System Stimulants (1) · Cerebrovascular Circulation (1) · Continuous Positive Airway Pressure (1) · Core Binding Factors (1) · Counseling (1) · Eszopiclone (1) · Fecal Microbiota Transplantation (1) · Methylphenidate (1) · Phototherapy (1) · Pramipexole (1) · Sugars (1)
University of California, San Diego (2) · Afasci Inc (1) · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (1) · IWK Health Centre (1) · Johns Hopkins University (1) · Kyowa Kirin, Inc. (1) · M.D. Anderson Cancer Center (1) · Massachusetts General Hospital (1) · National Institute of Nursing Research (NINR) (1) · Neurim Pharmaceuticals Ltd. (1) · Peking University Sixth Hospital (1) · Somnus Therapeutics, Inc. (1) · Southeast Renal Research Institute (1) · St. Joseph's Healthcare Hamilton (1) · Takeda (1)
United States (11) · Canada (3) · China (1) · Israel (1) · United Kingdom (1)
Alexandra Kearson, BA (1) · Atul Malhotra, MD (1) · Benicio N Frey, MD, MSc, PhD (1) · Beth E. Safirstein, MD (1) · Christopher Schmickl (1) · Claudia Campbell, PhD (1) · D. Alan Lankford, PhD (1) · David J. Seiden, MD (1) · Eric C Strain, MD (1) · Helene A. Emsellem, MD (1) · Hiroto Kuwabara, MD (1) · James A Tumlin, MD (1) · James K. Walsh, PhD (1) · James Williams, MD (1) · Jeannie Leoutsakos, PhD (1)
PMID 18853704, PMID 24971004, PMID 31924662, PMID 33189083, PMID 40705710, PMID 42026772
K23HL151880 (1), R21DA052861 (1), U01HL150568 (1)