Sleep Initiation and Maintenance Disorders: Clinical Trials

1533 completed, 330 recruiting, 315 unknown, 251 not yet recruiting. 1825 Not applicable, 170 Phase 2, 169 Phase 3, 137 Phase 4, 81 Phase 1.

By phase and status

Phase	Trials	Status
Not applicable	1825	Completed 990, Recruiting 245, Unknown 229, Not yet recruiting 192, Active not recruiting 59, Terminated 47, Enrolling by invitation 32, Withdrawn 26, Suspended 5
Phase 2	170	Completed 120, Recruiting 19, Not yet recruiting 9, Terminated 8, Unknown 8, Active not recruiting 3, Withdrawn 3
Phase 3	169	Completed 129, Terminated 13, Unknown 9, Recruiting 8, Not yet recruiting 4, Withdrawn 4, Active not recruiting 2
Phase 4	137	Completed 81, Unknown 13, Recruiting 12, Terminated 12, Not yet recruiting 9, Withdrawn 8, Active not recruiting 1, Enrolling by invitation 1
Phase 1	81	Completed 64, Unknown 8, Terminated 3, Not yet recruiting 2, Recruiting 2, Active not recruiting 1, Withdrawn 1
Early Phase 1	18	Completed 7, Not yet recruiting 3, Recruiting 3, Unknown 3, Active not recruiting 1, Terminated 1

Follow Sleep Initiation and Maintenance Disorders: new trials by email Literature Review of Sleep Initiation and Maintenance Disorders trials Research Report on Sleep Initiation and Maintenance Disorders

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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
Buddhist Awareness Training Program and Qigong Psychosocial Interventions for People With Insomnia Psychosocial intervention - Insomnia, Randomised Controlled Trial	Not applicable	Suspended	College of Professional and Continuing Education Limited	86	2030-01-01	2026-03-19
Effect of Music Therapy on Postoperative Health Outcomes Music therapy - Music Therapy	Not applicable	Not yet recruiting	Cairo University	60	2027-12-01	2025-08-14
Effect of Opioid-free Anesthesia on Sleep Quality, Cognitive Function and Recovery Quality After General Anesthesia in Elderly Patients Opioid-free Analgesics, Opioid group - Opioid-Free Anesthesia, POCD	Not applicable	Not yet recruiting	Beijing Friendship Hospital	88	2027-10-01	2026-10-20
Grain Moxibustion Treatment on Insomnia: a Randomized Controlled Trial Grain moxibustion, Sham grain moxibustion, Standard care - Sleep Initiation and Maintenance Disorders	Not applicable	Not yet recruiting	Shanghai Institute of Acupuncture, Moxibustion and Meridian	102	2027-07-01	2025-05-14
Telenursing-Based Sleep Coaching for Adults Living With HIV With Insomnia Symptoms Telenursing-based sleep coaching - Insomnia, HIV Infections	Not applicable	Not yet recruiting	Universitas Indonesia	50	2027-04-01	2026-10-23
AI-Powered Sleep Hygiene Mentor for Adults Living With HIV AI-powered sleep hygiene mentor - Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders	Not applicable	Not yet recruiting	Universitas Indonesia	100	2027-03-01	2026-10-26
Study of Bedroom Environment Sleep Intervention at Home for Older Adults Living Alone With Memory Concerns Bedroom Environment Tailoring, Sleep Health Education - Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI)	Not applicable	Not yet recruiting	Johns Hopkins University	40	2027-02-01	2026-10-09
HALO Clarity™ Cranial Alternating Current Stimulation Therapy for Adults With Moderate-to-Severe Insomnia Transcranial alternating current stimulator - Moderate to Severe Insomnia	Not applicable	Not yet recruiting	Nexalin Technology	160	2027-01-30	2026-10-30
Effects of Daily Avocado Consumption on Sleep and Skin Health in Postmenopausal Females Hass Avocado, Safflower Oil - Poor Sleep Quality	Not applicable	Not yet recruiting	San Diego State University	74	2027-01-01	2026-10-19
Racism-related Stress and Objective Short-sleep as Moderators of Treatment Effect in Cognitive Behavioral Therapy for Insomnia Cognitive Behavioral Therapy for Insomnia (CBTi) - Insomnia, Stress	Not applicable	Not yet recruiting	Johns Hopkins University	100	2027-01-01	2026-09-10
Web-Based Insomnia Treatment for Spousal Dementia Caregivers (SHUTi-DC) SHUTi-DC, PE - Insomnia	Not applicable	Not yet recruiting	University of Missouri-Columbia	80	2027-01-01	2026-09-23
Sleep MAPP in the Polytrauma/TBI System of Care Sleep MAPP Care Pathway - Insomnia Disorder, Mild Traumatic Brain Injury	Not applicable	Not yet recruiting	VA Office of Research and Development	900	2027-01-01	2026-10-21
Kava Aging and Mobility Study AB-free kava, Placebo - Old Adults, Sleep Quality	Early Phase 1	Not yet recruiting	University of Florida	40	2026-12-01	2026-08-31
Cost-Effectiveness Analysis of the Healthy Beat Acupunch Regimen on Physical Fitness, Sleep Quality, and Quality of Life Among Community-Dwelling Older Adults Healthy Beat Acupunch (HBA) Exercise Program - Healthy Aging, Health Promotion	Not applicable	Not yet recruiting	Mahidol University	92	2026-12-01	2026-10-09
Transcendental Meditation Intervention to Reduce Burnout and Enhance Resilience Among NewYork-Presbyterian Hospital and Weill Cornell Medicine Employees and Residents Transcendental Meditation - Anxiety, Depression - Major Depressive Disorder	Not applicable	Not yet recruiting	Weill Medical College of Cornell University	15	2026-11-15	2026-10-09
Neurofeedback for Episodic Migraine Neurofeedback - Episodic Migraine	Not applicable	Not yet recruiting	University of Salamanca	66	2026-11-15	2026-06-22
Effect of Guided Imagery on Sleep Quality, State Anxiety, and Comfort in Patients With Acute Coronary Syndrome Guided Imagery - Acute Coronary Syndromes (ACS)	Not applicable	Not yet recruiting	Afyonkarahisar Health Sciences University	64	2026-11-15	2026-08-31
Sleep Quality, Adiposity and Diet Quality Type 2 Diabetes Mellitus, Health Adult Subjects		Not yet recruiting	Izmir Democracy University	209	2026-11-15	2026-10-13
Mandala Coloring in Late Pregnancy Mandala Coloring Group - Pregnancy, Anxiety	Not applicable	Not yet recruiting	Fidan Balkaya	186	2026-11-10	2026-10-30
Does the Timing of Insomnia Therapy (CBT-i) Impact the Usage and Compliance of Upper Airway Stimulation (UAS) Treatment of Obstructive Sleep Apnea (OSA) Digital Cognitive Behavioral Therapy (CBT-i)-COAST - Obstructive Sleep Apnea, Comorbid Insomnia and Sleep Apnea	Not applicable	Not yet recruiting	Thomas Kaffenberger	100	2026-11-05	2026-09-24

Showing 20 of 2690. Sign in to see all of them.

Narrower conditions

Depression (274)  ·  Anxiety Disorders (269)  ·  Sleep Wake Disorders (177)  ·  Fatigue (154)  ·  Parasomnias (138)  ·  Pain (137)  ·  Motor Activity (102)  ·  Stress Disorders, Post-Traumatic (70)  ·  Psychological Well-Being (66)  ·  Neoplasms (57)  ·  Chronic Pain (53)  ·  Breast Neoplasms (44)  ·  Sleep Apnea, Obstructive (44)  ·  Sleep Deprivation (41)

Broader conditions

Nervous System Diseases (2685)  ·  Dyssomnias (2679)  ·  Sleep Disorders, Intrinsic (2679)  ·  Mental Disorders (2653)  ·  Sleep Wake Disorders (2513)  ·  Pathological Conditions, Signs and Symptoms (788)  ·  Signs and Symptoms (689)  ·  Behavior (545)  ·  Neurologic Manifestations (495)  ·  Behavioral Symptoms (335)  ·  Pathologic Processes (187)  ·  Central Nervous System Diseases (159)  ·  Respiratory Tract Diseases (154)  ·  Brain Diseases (143)  ·  Musculoskeletal Diseases (116)

Interventions

Cognitive Behavioral Therapy (214)  ·  Zolpidem (65)  ·  Eszopiclone (45)  ·  ramelteon (43)  ·  suvorexant (40)  ·  Exercise (33)  ·  Melatonin (31)  ·  daridorexant (22)  ·  lemborexant (22)  ·  Acupuncture Therapy (21)  ·  Control Groups (19)  ·  Sleep (19)  ·  Therapeutics (19)  ·  Gabapentin (16)  ·  Dexmedetomidine (15)

Sponsors

VA Office of Research and Development (50)  ·  The University of Hong Kong (46)  ·  Takeda (25)  ·  Chinese University of Hong Kong (24)  ·  Karolinska Institutet (24)  ·  University of Pennsylvania (24)  ·  Brigham and Women's Hospital (23)  ·  Stanford University (23)  ·  Ataturk University (22)  ·  The Hong Kong Polytechnic University (22)  ·  Merck Sharp & Dohme LLC (20)  ·  Taipei Medical University (20)  ·  Massachusetts General Hospital (19)  ·  University of Pittsburgh (19)  ·  Sanofi (18)

Countries

United States (899)  ·  Turkey (Türkiye) (383)  ·  China (187)  ·  Taiwan (122)  ·  Canada (104)  ·  Hong Kong (85)  ·  France (75)  ·  Sweden (58)  ·  United Kingdom (58)  ·  Spain (56)  ·  Germany (50)  ·  Brazil (44)  ·  Switzerland (34)  ·  Denmark (33)  ·  Belgium (31)

Top investigators

Charles H Tegeler, MD (5)  ·  Dong-Xin Wang, MD, PhD (5)  ·  Andrew Krystal, MD (4)  ·  Christina S McCrae, PhD (4)

Results publications

PMID 41170811, PMID 2748771, PMID 36000763, PMID 33189083, PMID 31926466, PMID 33813233, PMID 37526060, PMID 37796657, PMID 16155782, PMID 19327100, PMID 27503746, PMID 28265715, PMID 28427826, PMID 36529106, PMID 12749557, PMID 17520797, PMID 1798888, PMID 20191935, PMID 21208574, PMID 21532953, PMID 22207903, PMID 22294820, PMID 24733354, PMID 25266438, PMID 25276739, PMID 25526970, PMID 25594808, PMID 27198953, PMID 27397664, PMID 29112763, PMID 30522875, PMID 31915624, PMID 32351205, PMID 33210445, PMID 34077032, PMID 35065036, PMID 35149627, PMID 35254948, PMID 36054921, PMID 3650169, PMID 36530383, PMID 37477771, PMID 37526436, PMID 38302765, PMID 38644625, PMID 39374004, PMID 39436396, PMID 40992766, PMID 41217192, PMID 41430672

NIH funding

2015 (8), 2023 (6), 2025 (4), 2004 (3), 2019 (3), 2017 (2), 4UL1TR000427-10 (2), K23NR010408 (2), P30CA014520 (2), R34AT012767 (2), 1IK2CX000855 (1), 1IK2HX001548-01A2 (1), 1IK2RX001836-01A1 (1), 1UG3HL161342-01A1 (1), 2005 (1)