Actively Recruiting

Phase 4
Age: 40Years - 62Years
FEMALE
NCT07136415

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

Led by Brigham and Women's Hospital · Updated on 2026-03-17

1000

Participants Needed

5

Research Sites

259 weeks

Total Duration

On this page

Sponsors

B

Brigham and Women's Hospital

Lead Sponsor

P

Patient-Centered Outcomes Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 40Years - 62Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 40-62 years
  • Assigned female sex at birth
  • In peri- or early menopause, defined by irregular menstrual cycle or within 5 years from last menstrual period, or over 45 with hot flashes if menstrual markers are absent
  • Insomnia severity index score greater than 10 at screening
  • Insomnia started or worsened during peri- or early menopause
  • English or Spanish speaking (Spanish-only speakers to be recruited after materials are available)
Not Eligible

You will not qualify if you...

  • Untreated severe sleep apnea
  • Untreated moderate to severe restless legs syndrome
  • Severe daytime sleepiness (Epworth Sleepiness Scale over 15) at screening
  • Sleep schedule incompatible with interventions (e.g., night shift work more than once a week, main sleep period outside 8pm to 11am)
  • Regular use of hypnotics more than 2 nights per week
  • Limited internet access
  • Pregnant or breastfeeding, or positive pregnancy test at baseline
  • Prolonged QTc interval over 460 ms on electrocardiogram
  • History of uncontrolled hypertension or significant heart disease
  • Hypersomnia or narcolepsy
  • Bipolar disorder, severe depression, or psychosis
  • Seizure within the past year
  • Use of opioids or substance use disorder
  • Known allergy or contraindications to trazodone or daridorexant
  • Severe chronic liver disease or end-stage renal disease on dialysis
  • Other severe medical conditions increasing participation risk
  • Use of medications that prolong QT interval or strongly affect CYP3A4
  • Use of any study interventions in past 6 months
  • Other conditions determined by study clinician to prevent participation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 5 locations

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02120

Actively Recruiting

2

Henry Ford Medical Center

Novi, Michigan, United States, 48377

Not Yet Recruiting

3

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States, 27103

Not Yet Recruiting

4

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

Not Yet Recruiting

5

University of Utah

Salt Lake City, Utah, United States, 84108

Not Yet Recruiting

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Research Team

S

Sharon Ng, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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