Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age40-62
SponsorBrigham and Women's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Age 40-62 years
Assigned female sex at birth
In peri- or early menopause, following the STRAW criteria of self-report of irregular menstrual cycle or within 5 years from the last menstrual period. When menstrual markers are absent or unreliable (e.g., hysterectomy; endometrial ablation), participants must be older than 45 years old and report hot flashes
Insomnia severity index score > 10 at screening
Disqualifiers
Untreated, previously diagnosed severe sleep apnea (self-report; chart review; clinician assessment)
Untreated, previously diagnosed moderate-severe restless legs syndrome (self-report; chart review)
Severe daytime sleepiness (Epworth Sleepiness Scale > 15) at screening
Sleep schedule issues that would impact effectiveness of the interventions (e.g., night shift workers with >1 night shift/week; main sleep period outside of 8pm - 11am)
Trial design
Treatments tested in this trial
- Cognitive behavioral therapy for insomnia (CBT-i)
- Trazodone
- Daridorexant
Treatment groups
1,000 Participants
are divided into 3 treatment groupsSponsors and collaborators
Brigham and Women's Hospital
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
University of Pittsburgh
Collaborator
University of Utah
Collaborator
Massachusetts General Hospital
Collaborator
Henry Ford Health System
Collaborator
Wake Forest University Health Sciences
Collaborator
Source ClinicalTrials.gov