Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 4

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

NCT07136415 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 1,000 participants
Start Date 2026-02-13
Est. Completion 2031-02
Phase Phase 4

Sponsor

Brigham and Women's Hospital

929 total trials

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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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 929 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07136415 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Massachusetts, Michigan, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07136415?

This trial is sponsored by Brigham and Women's Hospital, which has 929 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial