Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms
Status:
NOT_YET_RECRUITING
Trial end date:
2030-01-01
Target enrollment:
Participant gender:
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 therapies work for people from different socio-demographic backgrounds, who are at different stages of menopause, and who have different menopause-associated conditions (e.g., sleep apnea, mood disturbance, etc.)?
What medical problems do participants have when taking part in these treatments?
Participants will:
Be asked to take trazodone every night, take daridorexant every night, or participate in a behavioral program for insomnia, for a duration of 12 months.
Participate in a total of one in-person visit and 5 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 at 5 time-points over the 12 months.
Phase:
PHASE4
Details
Lead Sponsor:
Brigham and Women's Hospital
Collaborators:
Henry Ford Health System Massachusetts General Hospital Patient-Centered Outcomes Research Institute University of Pittsburgh University of Utah Wake Forest University Health Sciences