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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Cognitive behavioral therapy for insomnia (CBT-i)
BehavioralThis is a program called SHUT-i and is composed of six self-guided sessions on a website over 6-9 weeks. Each session will be about 45-60 minutes long. CBT-I involves changing behaviors that cause sleep problems to persist. However, it also includes teaching skills to teach the participant to identify thoughts and feelings that may contribute to sleep problems.
Trazodone
DrugTrazodone is a heterocyclic medication that is FDA-approved for depression (starting dose 150mg). An estimated 4 in 5 trazodone prescriptions are for insomnia. Low-dose trazodone's frequent off-label use stems from a long-standing perception that trazodone is an effective and safer sleep aid compared to other drugs despite potential risks documented in small studies. A starting dosage of 25 mg will be used. After 1 week, patients will be instructed to increase the dose as needed to 50mg if tolerated. A second dose adjustment will be made at 4 weeks. At four weeks, study staff will contact participants and review medication adherence, and a standardized checklist will be used to assess ongoing symptoms and side effects and to consider an increase in dose to 100mg.
Daridorexant
DrugDaridorexant is a DORA drug. Dual orexin receptor antagonists (DORAs) are the newest class of FDA-approved medications for insomnia based on efficacy data from pivotal clinical trials demonstrating their efficacy for sleep onset and maintenance. A single dose of 50 mg (1 pill each night within 30 minutes of bedtime) was selected based on better efficacy without evidence of higher risks than the 25mg dose. However, 25mg dosage will be instructed if the participant has moderate liver impairment and/or taking a moderate CYP3A4 inhibitor.
Treatment groups
1,000 Participants
are divided into 3 treatment groupsGroup A: Cognitive behavioral therapy for insomnia (CBT-i)Active comparator 1 intervention
Group B: TrazodoneActive comparator 1 intervention
Group C: DaridorexantActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
PROMIS Sleep Disturbance T-score
The primary outcome is PROMIS sleep disturbance, which fulfills the criteria for content validity of a patient-reported outcome with reported relevance, comprehensiveness, ease of use, and treatment responses among people with menopause-related insomnia from diverse geographic locations. Sleep disturbance is one of the most bothersome symptoms of the menopause transition and one of the top reasons health care providers report women seek care. The PROMIS sleep disturbance scale will be used and the possible range of raw score is 8-40. A higher score means higher levels of sleep disturbance. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.
Time frame
6 MonthsSecondary outcomes
1
PROMIS Sleep-related Impairment Score
Validated questionnaire assessing daytime alertness. The PROMIS sleep-related impairment scale will be used and the possible range of raw score is 8-40. A higher score means higher levels of sleep-related impairment.
Time frame
6 months2
Sleep latency (average)
Measurement of time it takes to fall asleep after going to rest. This is measured in time units (minutes, hours) by self-report and Fitbit. This will be analyzed as a 7-day average.
Time frame
6 months3
Client Satisfaction Measure
This is measured via the Client Satisfaction Questionnaire. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Time frame
6 months4
Vasomotor Symptoms
The severity and frequency of vasomotor symptoms assessed via self-report and measured by Likert scale and number of hot flashes per day/night, respectively.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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