Insomnia Clinical Trials

58 studies are recruiting for insomnia in the United States right now. Each one is listed on ClinicalTrials.gov, the public registry the research teams themselves file with. TrialBoost is not a doctor, a research site, or a study sponsor: the research team decides who takes part.

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Studies now recruiting

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

   This pilot study will recruit Black/African American prostate cancer survivors into a clinical trial and will randomize each person to 1 of 2 possible treatments - an internet-based treatment for insomnia called Sleep Healthy Using the Internet (SHUTi) or an educational website. SHUTi provides the …

   Stage

   Not phased

   Ages

   21 and older

   Site

   Georgetown Lombardi Comprehensive Cancer Center, Washington D.C., District of Columbia

   Run by

   Georgetown University

   See if you can join NCT07128927 on ClinicalTrials.gov

2. Deep Sleep in Older Adults

   This double blind randomized clinical trial on older independent-living healthy individuals with symptoms of insomnia will harness Cognitive Behavioral Therapy for Insomnia (CBT-I) and augment it with ambulatory data collection devices, personalized digital content, and smart sound and light cues (…

   Stage

   Phase 2

   Ages

   55 and older

   Site

   SleepSpace, New York, New York

   Locations

   2 in total

   Run by

   Proactive Life Inc

   See if you can join NCT07316153 on ClinicalTrials.gov

3. Suvorexant for Treatment of AUD and PTSD

   This study is to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD). All participants will have a 7-day placebo run-in period, followed by a random a…

   Stage

   Phase 2

   Ages

   21 to 65

   Site

   The University of Texas Health Science Center - Houston, Houston, Texas

   Locations

   2 in total

   Run by

   Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

   See if you can join NCT06679062 on ClinicalTrials.gov

4. Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection

   The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the c…

   Stage

   Phase 2

   Ages

   18 to 65

   Site

   University of Kansas Medical Center- Sleep, Health and Wellness Laboratory, Kansas City, Kansas

   Run by

   University of Kansas Medical Center

   See if you can join NCT06434571 on ClinicalTrials.gov

5. Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children

   This study will evaluate the efficacy of a structured parent-mediated behavioral intervention called Sleep Parent Treatment (SPT) for insomnia in autistic children ages 3 to 7 years 11 months, compared to another behavioral intervention called Sleep Parent Education (SPE). Eligible children will be…

   Stage

   Not phased

   Ages

   3 to 7

   Site

   Cleveland Clinic Children's Center for Autism, Cleveland, Ohio

   Locations

   3 in total

   Run by

   The Cleveland Clinic

   See if you can join NCT07435740 on ClinicalTrials.gov

6. CBTi for the Treatment of Insomnia in Type 1 Diabetes

   The goal of this study is to learn if treating insomnia with a therapy intervention in people with type 1 diabetes will help to better control sugar levels, sleep, and quality of life. The questions this study aims to answer include: Will this intervention help the insomnia symptoms? Will obtaining…

   Stage

   EARLY_Phase 1

   Ages

   18 to 65

   Site

   University of Illinois Chicago, Chicago, Illinois

   Run by

   University of Illinois at Chicago

   See if you can join NCT07091318 on ClinicalTrials.gov

7. Insomnia and Insulin Resistance

   Insomnia symptoms are linked to metabolic syndrome (MetS), which includes abnormal glucose metabolism, insulin resistance (IR), and incidence of diabetes. Chronic sleep deficit is a major predictor of disease and early mortality. Further, insomnia is the most common sleep disorder in the United Sta…

   Stage

   Not phased

   Ages

   18 to 50

   Site

   University of Missouri, Columbia, Missouri

   Run by

   University of Missouri-Columbia

   See if you can join NCT07333586 on ClinicalTrials.gov

8. A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)

   People with opioid use disorder (OUD) can have trouble falling or staying asleep. Researchers want to know if suvorexant will help people with OUD fall asleep and stay asleep. The goal of this study is to learn about the safety of suvorexant and how well people tolerate it. Researchers also want to…

   Stage

   Phase 3

   Ages

   18 to 70

   Site

   Cenexel CNS ( Site 2012), Garden Grove, California

   Locations

   13 in total

   Run by

   Merck Sharp & Dohme LLC

   See if you can join NCT06655883 on ClinicalTrials.gov

9. A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia

   The purpose of this study is to assess the relative effectiveness, safety, and durability of the most commonly used prescription (zolpidem, trazodone) and over-the-counter (OTC) (melatonin, diphenhydramine) medications for insomnia, as well as a less commonly used prescription that may have a bette…

   Stage

   Phase 4

   Ages

   18 to 80

   Site

   University of Pennsylvania, Philadelphia, Pennsylvania

   Run by

   University of Pennsylvania

   See if you can join NCT07542756 on ClinicalTrials.gov

10. Sleep as a Mechanism of Change in Alcohol Use

    This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.

    Stage

    Not phased

    Ages

    18 to 49

    Site

    University of Missouri-Columbia, Columbia, Missouri

    Run by

    University of Missouri-Columbia

    See if you can join NCT06286774 on ClinicalTrials.gov

11. Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

    The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested cognitive behavioral therapy for insomnia (CB…

    Stage

    Not phased

    Ages

    65 and older

    Site

    Massachusetts General Hospital, Boston, Massachusetts

    Run by

    Massachusetts General Hospital

    See if you can join NCT06375265 on ClinicalTrials.gov

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

    The proposed pilot will examine feasibility, acceptability, and preliminary efficacy of a digital CBT-I tailored for school-aged children.

    Stage

    Not phased

    Ages

    6 to 12

    Site

    University of South Florida, Tampa, Florida

    Run by

    University of South Florida

    See if you can join NCT07091149 on ClinicalTrials.gov

13. Enhancing Diabetes Care by Treating Insomnia

    Insomnia is highly prevalent in individuals with type 2 diabetes (T2D) and is associated with poor glycemic control. Louisiana has one of the highest diabetes prevalence rates in the U.S., with significant disparities by race, income, and rural residence. Despite growing recognition of sleep's role…

    Stage

    Not phased

    Ages

    40 and older

    Site

    Southeast Community Health Systems, Zachary, Louisiana

    Run by

    Tulane University

    See if you can join NCT07062406 on ClinicalTrials.gov

14. Piloting an Insomnia Treatment in Patients With Ulcerative Colitis

    The goal of this clinical trial is to learn if telehealth-based Cognitive Behavioral Therapy for Insomnia (CBT-I) adapted for Ulcerative Colitis (UC) works to treat insomnia in adults with UC. The main questions it aims to answer are: * Is telehealth-based CBT-I adapted for UC feasible and acceptab…

    Stage

    Not phased

    Ages

    18 and older

    Site

    Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire

    Run by

    Dartmouth-Hitchcock Medical Center

    See if you can join NCT07428629 on ClinicalTrials.gov

15. Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

    The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK…

    Stage

    Not phased

    Ages

    0 to 20

    Site

    Lucile Packard Children's Hospital, Palo Alto, California

    Locations

    52 in total

    Run by

    Duke University

    See if you can join NCT04278404 on ClinicalTrials.gov

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

    This pilot study will assess the usefulness and potential effectiveness of using transcutaneous auricular vagus nerve stimulation (tVNS) for treating insomnia in adult survivors of childhood acute lymphoblastic leukemia (ALL). Participants will be randomized to receive either active (verum) or inac…

    Stage

    Not phased

    Ages

    20 to 50

    Site

    St. Jude Children's Research Hospital, Memphis, Tennessee

    Run by

    St. Jude Children's Research Hospital

    See if you can join NCT07191119 on ClinicalTrials.gov

17. Multi-center Trial to Improve Nocturia and Sleep in Older Adults

    The Multi-center Trial to Improve Nocturia and Sleep in Older Adults (MINT) study is a randomized trial to determine and assess the efficacy of integrated treatment of coexisting nocturia and insomnia, as well as explore the effects of this treatment on quality of life.

    Stage

    Not phased

    Ages

    60 and older

    Site

    VA Greater Los Angeles Healthcare System, Los Angeles, California

    Locations

    2 in total

    Run by

    Atlanta VA Medical Center

    See if you can join NCT06110091 on ClinicalTrials.gov

18. Does Style Matter: Comparison of Moderate- to Low-intensity Styles of Yoga

    The goal of this clinical trial is to learn if yoga works to improve sleep and heart health in adults with and without insomnia disorder. The main questions it aims to answer are: * Does the style of yoga impact participants heart health overnight? * Does the style of yoga improve participants slee…

    Stage

    Not phased

    Ages

    18 to 40

    Site

    University of Central Florida, Orlando, Florida

    Run by

    Caitlin Cheruka

    See if you can join NCT07638267 on ClinicalTrials.gov

19. Treatments for Insomnia in Veterans With PTSD

    This randomized trial will compare a novel treatment, Acceptance of the Behavioral Changes to Treat Insomnia (ABC-I) to Cognitive Behavioral Therapy for Insomnia (CBT-I) among Veterans with comorbid Post-Traumatic Stress Disorder (PTSD) and insomnia disorder. ABC-I combines the behavioral component…

    Stage

    Not phased

    Ages

    18 and older

    Site

    VA Greater Los Angeles Healthcare System, Sepulveda, CA, Sepulveda, California

    Locations

    2 in total

    Run by

    VA Office of Research and Development

    See if you can join NCT05194930 on ClinicalTrials.gov

20. CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

    This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia sy…

    Stage

    Not phased

    Ages

    18 and older

    Site

    Intrepid Spirit Center - Eglin Air Force Base, Eglin Air Force Base, Florida

    Locations

    5 in total

    Run by

    Johns Hopkins University

    See if you can join NCT05663034 on ClinicalTrials.gov

21. Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects

    The goal of this clinical trial is to learn about how certain medications used to treat insomnia (e.g., Lemborexant) impact sleep, mood, and behavior in men and women with Opioid Use Disorder who are taking prescribed buprenorphine. The main questions it aims to answer are: 1. What is the effect of…

    Stage

    Phase 2

    Ages

    18 and older

    Site

    VCU Institute for Drug and Alcohol Studies, Richmond, Virginia

    Run by

    Virginia Commonwealth University

    See if you can join NCT06981195 on ClinicalTrials.gov

22. Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain

    The purpose of this research study is to test whether Brief Behavioral Treatment for Insomnia (BBTI) delivered over the phone or Brief Mindfulness Training (BMT) delivered over the phone is better able to improve the symptoms of insomnia, reduce chronic pain, and slow the pace of biological aging i…

    Stage

    Not phased

    Ages

    25 to 65

    Site

    Washington University School of Medicine, St Louis, Missouri

    Run by

    Washington University School of Medicine

    See if you can join NCT07270406 on ClinicalTrials.gov

23. Mindfulness Meditation for Insomnia

    The investigators will conduct a 3-arm, pilot RCT where participants (N=30) will be randomized in a 1:1:1 design to 4 weeks of instructed bedtime MM practice at night (n=10) vs. uninstructed MM (n=10) vs. sleep hygiene education only (n=10). Aim 1 is to understand the feasibility and acceptability …

    Stage

    Phase 1

    Ages

    18 and older

    Site

    Brigham and Women's Hospital, Boston, Massachusetts

    Run by

    Brigham and Women's Hospital

    See if you can join NCT06972303 on ClinicalTrials.gov

24. Training in Evidence-based Treatments in Psycho-Oncology

    The goal of this research study is to train psychotherapists to administer individualized evidence-based psychotherapies in a cancer care setting to patients and caregivers with elevated levels of distress. The intervention will mirror clinical care in psycho-oncology in which the therapist, collab…

    Stage

    Not phased

    Ages

    18 and older

    Site

    Massachusetts General Hospital Cancer Center, Boston, Massachusetts

    Run by

    Massachusetts General Hospital

    See if you can join NCT05674357 on ClinicalTrials.gov

25. Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms

    The goal of this clinical trial is to learn how three current insomnia therapies (trazodone, daridorexant, cognitive behavioral therapy for insomnia) compare with each other in peri- and post-menopausal women. It will also learn about the safety of the treatments. The main questions it aims to answ…

    Stage

    Phase 4

    Ages

    40 to 62

    Site

    Brigham and Women's Hospital, Boston, Massachusetts

    Locations

    5 in total

    Run by

    Brigham and Women's Hospital

    See if you can join NCT07136415 on ClinicalTrials.gov