Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms
Phase 4
1,000
about 5 years
40–62
Female only
5 sites in MA, MI, NC +2
What this study is about
Researchers are testing whether digital therapy, trazodone, or daridorexant are more effective than each other at treating insomnia in women going through menopause. The trial will also look at the safety of these treatments. Participants will use one of three methods to treat their insomnia for 12 months and provide information about their sleep and health.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Participate in Cognitive behavioral therapy for insomnia (CBT-i)
- 2.Take Daridorexant
- 3.Take Trazodone
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
daridorexant, trazodone
oral (Oral Tablet)
Primary: PROMIS Sleep Disturbance T-score
Secondary: Insomnia Severity Index, Menopause-related Quality of Life, Occurrences of events of special interest and/or adverse events, PROMIS Anger Scale, PROMIS Anxiety Scale, PROMIS Cognitive Function Abilities Scale, PROMIS Depression Scale, PROMIS Fatigue Score
therapy