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ClinicalTrials.gov 62 recruiting now official registry

Insomnia clinical trials

62 of 152 indexed Insomnia trials are currently recruiting.

152 US clinical trials · 62 currently recruiting

Insomnia is the subject of 152 registered US clinical trials on ClinicalTrials.gov, 62 of them currently open to new participants. 17 are in Phase 3-4 (later-stage) and 21 in Phase 1-2 (earlier-stage). The most active sponsor is VA Office of Research and Development, running 9 of these trials.

The research picture

Insomnia has 152 registered US clinical trials, 62 of them open to new participants right now, about 41% of the total.

62
recruiting participants now
41%
of trials open to enrollment
17
in Phase 3–4 (later-stage)
9
top sponsor: VA Office of Research and Development
Phase 15Phase 216Phase 35Phase 412

Active & Recent Trials

152 total, page 2 of 4

RECRUITING NA 50 participants

Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

Massachusetts General Hospital

NCT06375265

RECRUITING NA 40 participants

Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia

St. Jude Children's Research Hospital

NCT07191119

RECRUITING NA 40 participants

Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy of NiteCAPP Jr

University of South Florida

NCT07091149

RECRUITING NA 40 participants

Assessing the Feasibility of Web-based Insomnia Treatment Among Prostate Cancer Survivors

Georgetown University

NCT07128927

RECRUITING 40 participants

Implementation & Dissemination of a Digital Health Intervention for Adolescent Sleep

University of Kansas Medical Center

NCT06840444

RECRUITING Phase 1 30 participants

Mindfulness Meditation for Insomnia

Brigham and Women's Hospital

NCT06972303

RECRUITING NA 30 participants

Treating Insomnia in Mild Cognitive Impairment

Beth Israel Deaconess Medical Center

NCT06687161

RECRUITING NA 28 participants

Adapted CBT-I for Adolescents With Insomnia : The DREAM-IT Study

Indiana University

NCT06541886

RECRUITING NA 25 participants

Forehead Temperature-Regulating Therapy for Insomnia in Adults With Tourette's Disorder

University of California, Los Angeles

NCT05499741

RECRUITING NA 15 participants

Novel Adaptive Cognitive Training in Autistic Adults with Co-occurring Insomnia

University of South Florida

NCT06291298

RECRUITING Early Phase 1 15 participants

CBTi for the Treatment of Insomnia in Type 1 Diabetes

University of Illinois at Chicago

NCT07091318

RECRUITING NA 10 participants

LiverSleep: A Behavioral Sleep Intervention for Patients With Cirrhosis and Insomnia

Massachusetts General Hospital

NCT07417163

ACTIVE NOT RECRUITING NA 1,000 participants

The Assessment of Human Sleep and Its Functions

StimScience

NCT07211646

ACTIVE NOT RECRUITING Phase 3 673 participants

National Adaptive Trial for PTSD Related Insomnia

VA Office of Research and Development

NCT03668041

ACTIVE NOT RECRUITING NA 456 participants

Perinatal Research on Improving Sleep and Mental Health

University of California, San Francisco

NCT05596318

ACTIVE NOT RECRUITING NA 240 participants

Remote STATE Training for Insomnia in Older Adults

Posit Science Corporation

NCT06589024

ACTIVE NOT RECRUITING NA 224 participants

Intervention for Sleep and Pain in Youth: a Randomized Controlled Trial

Seattle Children's Hospital

NCT04936321

ACTIVE NOT RECRUITING Phase 4 200 participants

Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial

ProofPilot

NCT04627480

ACTIVE NOT RECRUITING NA 152 participants

CBT-I to Improve Functional Outcomes in Veterans With Psychosis

VA Office of Research and Development

NCT04646200

ACTIVE NOT RECRUITING NA 134 participants

Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes (M-STAR Study)

University of Michigan

NCT04457674

ACTIVE NOT RECRUITING NA 100 participants

Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE)

Henry Ford Health System

NCT05356364

ACTIVE NOT RECRUITING Phase 2 98 participants

Effects of Mirtazapine on Appetite in Advanced Cancer Patients

M.D. Anderson Cancer Center

NCT00488072

ACTIVE NOT RECRUITING NA 80 participants

Neurotechnology Following Traumatic Brain Injury

Brain State Technologies

NCT03649958

ACTIVE NOT RECRUITING Phase 4 60 participants

Solriamfetol and CBT-I in Patients With Insomnia Disorder

University of Pennsylvania

NCT05838430

ACTIVE NOT RECRUITING NA 60 participants

A Conversational Agent (Cecebot) to Improve Insomnia in Stage I-III Breast Cancer Survivors

University of Washington

NCT06392789

ACTIVE NOT RECRUITING NA 60 participants

Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application

Brigham and Women's Hospital

NCT05991492

ACTIVE NOT RECRUITING 50 participants

Partial Sleep Restriction in Chronic Low Back Pain: A Feasibility Study

University of Kansas Medical Center

NCT07008924

ACTIVE NOT RECRUITING NA 42 participants

Comparing Virtual Yoga to Standard Care on Insomnia Among Cancer Survivors

University of Rochester

NCT04458194

ACTIVE NOT RECRUITING NA 14 participants

Nexalin Therapy as a Viable Adjunctive Treatment for Substance Use Disorders

University of Arizona

NCT03540745

COMPLETED NA 1,836 participants

Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study

Stanford University

NCT02037438

COMPLETED NA 746 participants

Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors

University of Rochester NCORP Research Base

NCT02613364

COMPLETED Phase 3 545 participants

A Study of Eszopiclone in Subjects With Insomnia Related to Major Depressive Disorder

Sumitomo Pharma America

NCT00368030

COMPLETED NA 542 participants

Hypertension With Unsatisfactory Sleep Health

University of Pittsburgh

NCT02508129

COMPLETED Phase 4 420 participants

Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder

Sumitomo Pharma America

NCT00235508

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 333 participants

Reducing Health Disparities for Black Women in the Treatment of Insomnia

Boston University

NCT03613519

COMPLETED NA 311 participants

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

University of Virginia

NCT03213132

COMPLETED Phase 3 304 participants

Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia

Sumitomo Pharma America

NCT00857220

COMPLETED 250 participants

Evaluation of the Reliability and Validity of a Diagnostic Sleep Disorders Questionnaire

Dayzz Live Well

NCT03468400

COMPLETED NA 208 participants

Research on Expecting Moms and Sleep Therapy

University of California, San Francisco

NCT02805998

COMPLETED Phase 4 197 participants

Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia

University of Pennsylvania

NCT03774810

COMPLETED NA 180 participants

Impact of Sleep Workshops in College Students

NYU Langone Health

NCT02665247

COMPLETED Phase 2 173 participants

Safety and Efficacy Study of APD125 in Patient With Insomnia

Arena Pharmaceuticals

NCT00452179

COMPLETED NA 167 participants

Preventing Insomnia With Virtual Oneshot Therapy (PIVOT)

Henry Ford Health System

NCT05523726

COMPLETED NA 160 participants

Choosing Options for Insomnia in Cancer Effectively (CHOICE): A Comparative Effectiveness Trial of Acupuncture and Cognitive Behavior Therapy

Memorial Sloan Kettering Cancer Center

NCT02356575

COMPLETED NA 128 participants

Treatments for Insomnia: Mediators, Moderators and Quality of Life

Palo Alto Veterans Institute for Research

NCT02117388

COMPLETED Phase 3 126 participants

Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis

University of Washington

NCT03534284

COMPLETED NA 114 participants

Dual Treatment of Chronic Pain and Insomnia

Mary Free Bed Rehabilitation Hospital

NCT05033418

COMPLETED Phase 4 108 participants

Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes

Massachusetts General Hospital

NCT03818581

COMPLETED NA 102 participants

Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers

University of Virginia

NCT04986904

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Phase Distribution

PhaseTrial count
Phase 1 5
Phase 2 16
Phase 3 5
Phase 4 12

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

Reading the Insomnia Trial Landscape

152 indexed Insomnia studies · 62 recruiting (41%).

Phase mix: 17 late (III/IV) vs 21 early (I/II).

Top sponsor: VA Office of Research and Development (9 trials), 9 others listed. 50 shown below, recruiting first.

How to read this condition's trial landscape

That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.

Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.

All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation, eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.

Frequently Asked Questions

How many clinical trials are there for Insomnia?

PlainTrial tracks 152 US clinical trials for Insomnia, of which 62 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Insomnia?

Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.

Is this data current?

Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.

Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2026 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

Verify with NIH →

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial for this condition, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.