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ClinicalTrials.gov 5 recruiting now early-phase tilt

Sleep Initiation and Maintenance Disorders: early-phase trial registry

5 of 20 indexed Sleep Initiation and Maintenance Disorders trials are currently recruiting, with more weight in Phase 1-2.

Corpus placement: #848 of 28,707 conditions by registered trial count.

20 US clinical trials · 5 currently recruiting · #848 of 28,707 conditions by registered trial count

Sleep Initiation and Maintenance Disorders: 20 US clinical trials tracked, 5 recruiting.

Sleep Initiation and Maintenance Disorders is the subject of 20 registered US clinical trials on ClinicalTrials.gov, 5 of them currently open to new participants. 3 are in Phase 3-4 (later-stage) and 7 in Phase 1-2 (earlier-stage). The most active sponsor is University of Virginia, running 3 of these trials.

Enrollment posture brief

Registry condition sleep-initiation-and-maintenance-disorders

OPEN 5 | RECR 25% | LATE 3 | EARLY 7 | RANK #848 | SPON 3

Nearest open-share peer: Abdominal Cancer (25% recruiting · 8 trials)

Advanced or Metastatic Solid55%ALS50%Abdominal Pain25%Acute Myocardial Infarction25%Sleep Initiation and Mai (th…25%
Open-enrollment share among volume-matched conditions near Sleep Initiation and Maintenance Disorders

Sleep Initiation and Maintenance Disorders lists 5 open slots (25% of 20 indexed trials). Peers are matched on registered volume, not therapeutic-area browse lists. How peer matching works →

Key findings

What ClinicalTrials.gov does not surface for Sleep Initiation and Maintenance Disorders on its own pages , computed from the registry mirror as of 2026-08-08. Each line carries its own denominator so it can be quoted as it stands.

  1. Sleep Initiation and Maintenance Disorders is recruiting below its size-band peers.

    5 of 20 indexed trials (25%) are open to enrollment, against a 39.7% average across 762 conditions with 20-99 trials. The peer set uses the same ClinicalTrials.gov-derived counts as this page.

  2. One sponsor concentrates Sleep Initiation and Maintenance Disorders research.

    University of Virginia accounts for 3 of 20 trials (15%). 18 distinct sponsors appear on at least one study for this condition label.

  3. Typical Sleep Initiation and Maintenance Disorders enrolment sits around 144 participants.

    Median target enrolment is 144 among the 20 trials that report a genuine target (sentinel values excluded). 7 of those (35%) plan for fewer than 100 participants.

  4. Sleep Initiation and Maintenance Disorders research is mostly interventional.

    18 interventional and 2 observational studies make up this index (90% interventional). Study type is sponsor-reported on ClinicalTrials.gov.

Phase 11Phase 26Phase 32Phase 41

Open and recent trials

20 total, page 1 of 1

RECRUITING NA 300 participants

Sleep for Health Study on the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk

Kaiser Permanente

NCT06067139

RECRUITING Phase 4 190 participants

Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress

VA Office of Research and Development

NCT03642028

RECRUITING Phase 2 144 participants

Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)

University of Virginia

NCT05565833

RECRUITING NA 60 participants

Optimizing Sleep Health in Nurses

Oregon State University

NCT05965609

RECRUITING Phase 1 30 participants

Mindfulness Meditation for Insomnia

Brigham and Women's Hospital

NCT06972303

ACTIVE NOT RECRUITING 861 participants

A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population

Eisai

NCT06744673

ACTIVE NOT RECRUITING NA 90 participants

Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanisms

Jonsson Comprehensive Cancer Center

NCT00690196

COMPLETED Phase 3 1,213 participants

Efficacy of Ramelteon in Subjects With Chronic Insomnia

Takeda

NCT00671086

COMPLETED Phase 3 848 participants

Efficacy and Safety of M100907 on Sleep Maintenance Insomnia With a Sub-study in Stable Type II Diabetes Mellitus

Sanofi

NCT00495885

COMPLETED Phase 2 400 participants

Efficacy Study of LY2422347 to Treat Insomnia

Eli Lilly and Company

NCT00259311

COMPLETED Phase 2 342 participants

Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia

GlaxoSmithKline

NCT00280423

COMPLETED NA 311 participants

Sleep Healthy Using The Internet for Older Adult Sufferers of Insomnia and Sleeplessness

University of Virginia

NCT03213132

COMPLETED NA 195 participants

Insomnia Self-Management in Heart Failure

Yale University

NCT02660385

COMPLETED Phase 2 135 participants

Efficacy Study of EVT 201 in the Treatment of Elderly Patients With Daytime Sleepiness

Evotec Neurosciences

NCT00401284

COMPLETED Phase 2 111 participants

Cognitive Behavioral Insomnia Therapy for Individuals With Fibromyalgia

Duke University

NCT00321451

COMPLETED NA 102 participants

Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers

University of Virginia

NCT04986904

COMPLETED NA 81 participants

Remote Study of NightWare for PTSD With Nightmares

NightWare

NCT03934658

COMPLETED Phase 2 48 participants

Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.

Stanford University

NCT00383643

COMPLETED 24 participants

Testing the Nocturnal Sleep Latency Profile in Primary Insomnia

University of Pittsburgh

NCT00167375

COMPLETED NA 24 participants

Cognitive Behavioral Therapy for Trauma-Related Insomnia in Veterans

Southeast Louisiana Veterans Health Care System

NCT01176123

Phase Distribution

PhaseTrial count
Phase 1 1
Phase 2 6
Phase 3 2
Phase 4 1

Named interventions

Most-linked intervention names on Sleep Initiation and Maintenance Disorders records (sponsor-reported on ClinicalTrials.gov). Counts are trial links, not unique products.

Patient Education Other
2 trials
Cognitive Behavioral Therapy for Insomnia Behavioral
2 trials
Matching Placebos Drug
1 trials
sodium oxybate Drug
1 trials
zolpidem tartrate Drug
1 trials
Self-Management Education for Heart Failure Behavioral
1 trials
NightWare Therapeutic System in Sham Mode Device
1 trials
NightWare Therapeutic System Device
1 trials

US sites by state

Facility locations filed on Sleep Initiation and Maintenance Disorders trials. A trial with sites in several states counts in each.

California 7 trials
North Carolina 4 trials
Arizona 4 trials
Virginia 3 trials
South Carolina 3 trials
New York 3 trials
New Jersey 3 trials
Florida 3 trials

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

What to do with this Sleep Initiation and Maintenance Disorders page

20 registered trials, 5 currently recruiting, is a starting point for a conversation, not a diagnosis or a recommendation.

  • 5 Sleep Initiation and Maintenance Disorders trials are currently recruiting, check eligibility criteria before contacting a site. Browse recruiting trials
  • University of Virginia sponsors the most Sleep Initiation and Maintenance Disorders trials on record, review their full trial history before evaluating a specific study. See University of Virginia's trials
  • Bring the specific trial ID (NCT number) to your own doctor before enrolling, this page is a directory, not medical guidance. Read the trial-finding guide

Trial and recruiting counts reflect ClinicalTrials.gov registry status as of the data vintage above; individual trial eligibility and enrollment status can change.

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This Sleep Initiation and Maintenance Disorders condition card totals 20 registered trials; most-linked intervention Patient Education; top US site state California. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.