Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07136415 · ClinicalTrials.gov registry record · Phase 4
Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms
A Phase 4 study of Insomnia and Menopausal Women, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 1,000
- Enrollment target
- 5
- Study locations
NCT07136415 is a Phase 4 study of Insomnia and Menopausal Women that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 1,000 participants, above the 164-participant average among 151 other Insomnia trials with a reported enrollment target (510% higher). The trial reports 5 study locations across 5 states.
The verdict
NCT07136415, a Phase 4 study of Insomnia and Menopausal Women, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 1,000 participants
- Enrollment target
- 5
- Study locations
Study Summary
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 answer are: Which commonly used insomnia therapies are most effective and safe for improving insomnia symptoms in peri- and post-menopausal people? How well do the treatments work for people from different backgrounds, who are at different stages of menopause, and who have different conditions common during menopause (e.g., sleep apnea, mood disturbance, etc.)? What medical problems do participants have when using these treatments? Participants will: Be asked to take trazodone every night, take daridorexant every night, or participate in an online behavioral program for insomnia, for a total of 12 months. Participate in a total of one in-person visit and 7 virtual visits (phone calls) over the 12 months. Wear (and keep) a Fitbit and fill out a daily sleep diary for at least 4 weeks over the 12 months. Fill out online surveys 4 times over the 12 months.
Conditions Studied
Interventions
- DRUG Daridorexant
- BEHAVIORAL Cognitive behavioral therapy for insomnia (CBT-i)
- DRUG Trazodone
Study Locations (5)
Massachusetts
- Brigham and Women's Hospital - Boston
Michigan
- Henry Ford Medical Center - Novi
North Carolina
- Atrium Health Wake Forest Baptist - Winston-Salem
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2026-02-13 |
| Est. Completion | 2031-02 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07136415
The ClinicalTrials.gov registry entry for NCT07136415 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 164-participant average among 151 other Insomnia trials with a reported enrollment target (510% higher). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Insomnia appearing as the primary indexed condition, and to 3 interventions - of which Daridorexant is the first listed.
NCT07136415 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Massachusetts, Michigan, North Carolina.
Frequently Asked Questions
What is clinical trial NCT07136415 about?
NCT07136415 is a clinical study titled "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 answe...
What is the current status of trial NCT07136415?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 1,000 participants. The study started on 2026-02-13. Estimated completion is 2031-02.
What conditions does trial NCT07136415 study?
This clinical trial studies the following conditions: Insomnia, Menopausal Women.
What interventions are being tested in trial NCT07136415?
The interventions under investigation include: Daridorexant (DRUG), Cognitive behavioral therapy for insomnia (CBT-i) (BEHAVIORAL), Trazodone (DRUG).
Who is sponsoring clinical trial NCT07136415?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07136415 being conducted?
This trial has 5 study locations across Massachusetts, Michigan, North Carolina, Pennsylvania, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Insomnia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Enhancing Hypnotic Medication Discontinuation in Primary Care
RECRUITING · Phase 4
-
Efficacy of Suvorexant in the Treatment of Insomnia in Midlife Women With Pre-Diabetes
RECRUITING · Phase 4
-
Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial
ACTIVE NOT RECRUITING · Phase 4
-
Solriamfetol and CBT-I in Patients With Insomnia Disorder
ACTIVE NOT RECRUITING · Phase 4
-
A Pilot Study of Suvorexant for Insomnia in Parkinson Disease
COMPLETED · Phase 4
-
Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes
COMPLETED · Phase 4
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.