Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms
- Conditions
- Menopausal WomenInsomnia
- Interventions
- Registration Number
- NCT07136415
- Lead Sponsor
- Brigham and Women's Hospital
- Brief 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.
- Detailed Description
Insomnia is a common condition experienced by about 1 in 10 adults. Insomnia is characterized by unhappiness with sleep quality or duration. Insomnia has been linked with a higher risk of depression, heart disease and cognitive decline, lower quality of life, and contributes to missing work and accidents. Sleep disturbances, such as insomnia, are also common complaints for individuals in the peri- and post-menopausal stages. Currently, limited evidence exists for insomnia treatment in peri- and post-menopausal people, with the recommended ways to improve insomnia involving cognitive-behavioral therapy for insomnia (CBT-I) and specific pharmacological therapies. CBT-I involves changes in behaviors, thoughts, and relaxation techniques. Daridorexant is approved by the U.S. Food and Drug Administration (FDA) to treat insomnia. Trazodone is FDA-approved to treat depression and often used off-label for insomnia. As in, it is used but not approved by the FDA to treat insomnia. It is unclear currently how well CBT-I works compared to trazodone and daridorexant, particularly among peri- and post-menopausal people. Throughout the duration of the study, the participant will be given one of the three therapies.
This study takes about 12 months to complete for each participant.
The following visits and procedures will happen:
Screening/Consent Visit: Consent process, baseline surveys, urine pregnancy test, height and weight assessment. The 7 days after this visit, the participant will also be asked to wear their Fitbit for 24 hours every day, fill in a sleep diary in the morning and night, and wear a home sleep apnea test for one night.
Randomization Call: The participant will be randomized (like a flip of a coin) to receive one of the three insomnia therapies (CBT-I, trazodone, or daridorexant) a week after their baseline visit.
3-Months and 6-Months Call/Visit: Fill out surveys. The 7 days after these visits, the participant will also be asked to wear their Fitbit for 24 hours every day and fill in a sleep diary in the morning and night.
9-Months Call: Quick phone call with study staff to see if there are any issues.
12-Months Call/Visit: Fill out surveys. The 7 days after these visits, the participant will also be asked to wear their Fitbit for 24 hours every day and fill in a sleep diary in the morning and night. The Fitbit is for the participant to keep and does not have to be returned.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 1000
- 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. In the absence of a reliable menstrual marker (e.g., hysterectomy; endometrial ablation), participants must be older than 45 years old and report hot flashes
- Insomnia severity index score > 10
- Insomnia started or worsened during peri- or early menopause
- English-speaking
- Untreated, previously diagnosed severe sleep apnea (self-report; chart review)
- Untreated, previously diagnosed moderate-severe restless legs syndrome (self-report; chart review)
- Severe daytime sleepiness (Epworth Sleepiness Scale > 15)
- Likelihood of limited benefit (e.g., night shift workers with >1 night shift/week; main sleep period outside of 8pm - 11am)
- Regular use of hypnotics > 2 nights/week
- Limited internet access
- Positive urine pregnancy test at baseline visit
- Prolonged QTc interval
- Excessive risk of interventions (e.g., known heart disease, history of bipolar or psychosis, severe depression, seizure within the past year, use of opioids/substance abuse disorder, pregnant or lactating, decompensated liver disease (Child-Pugh Class 3), use of strong CYP3A4 inhibitors, use of drugs that prolong the QTc interval, end-stage renal disease on hemodialysis, known allergy to trazodone or daridorexant (self-report and chart review))
- Use of one of the interventions in the past 6 months
- Severe medical comorbidity (e.g., End Stage Renal Disease, likely hospitalization within next 6 months)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive behavioral therapy for insomnia (CBT-i) Cognitive behavioral therapy for insomnia (CBT-i) Participants will be asked to take part in the CBT-i program over the course of 6-9 weeks, with the option of revisiting content throughout the study duration (12 months). Trazodone Trazodone Participants will be asked to take trazodone (oral pill administration) for the duration of the study (12 months), with safety monitoring conducted by study staff throughout the study. Dosage adjustments may occur. Daridorexant Daridorexant Participants will be asked to take daridorexant (oral pill administration) for the duration of the study (12 months), with safety monitoring conducted by study staff throughout the study.
- Primary Outcome Measures
Name Time Method PROMIS Sleep Disturbance T-score 6 Months 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.
- Secondary Outcome Measures
Name Time Method PROMIS Sleep-related Impairment Score 6 months 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.
Sleep latency (average) 6 months 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.
Client Satisfaction Measure 6 months This is measured via the Client Satisfaction Questionnaire. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Vasomotor Symptoms 6 months 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.
Occurrences of events of special interest and/or adverse events Throughout the study duration (up to 1 year) Occurrence of events of special interest (falls, fall-related injuries, drowsiness, dizziness, headache, nausea, dry mouth, palpitations) will be measured for each arm by self-report or chart review. Occurrence of adverse events will also be assessed by number of participants with treatment-related adverse events as defined by CTCAE v4.0
Number of awakenings 6 months Measure of number of awakenings per night by Fitbit.
Sleep duration 6 months Measured by Fitbit, in hours and minutes.
PROMIS Depression Scale 6 months The PROMIS depression scale will be used and the possible range of raw score is 8-40. A higher score means higher levels of depression symptoms.
PROMIS Anxiety Scale 6 months The PROMIS anxiety scale will be used and the possible range of raw score is 8-40. A higher score means higher levels of anxiety symptoms.
PROMIS Cognitive Function Abilities Scale 6 months The PROMIS cognitive function abilities scale will be used and the possible range of raw score is 4-20. A higher score represents better cognitive function.
PROMIS Anger Scale 6 months The PROMIS anger scale will be used and the possible range of raw score is 5-25. A higher score means higher levels of anger.
PROMISE Global Health Score 6 months The PROMIS global health scale will be used and the possible range of raw score is 8-40. A higher score indicates better physical and mental health.
PROMIS Fatigue Score 6 months The PROMIS fatigue scale will be used and the possible range of raw score is 8-40. A higher score indicates higher levels of fatigue.
PROMIS Interest in Sexual Activity Score 6 months The PROMIS interest in sexual activity scale will be used and the possible range of raw score is 2-10. A higher score indicates greater interest in sexual activity.
PROMIS Satisfaction with Sex Life Score 6 months The PROMIS satisfaction with sex life scale will be used and the possible range of raw score is 4-20. A higher score indicates higher satisfaction with sex life.
Menopause-related Quality of Life 6 months The menopause-related quality of life (MENQOL) scale will be used and the possible range of raw score is 29-232. A higher score indicates higher severity of menopause-related symptoms.
Work Productivity and Activity Impairment 6 months The Work Productivity and Activity Impairment - General Health (WPAI-GH) Questionnaire is a 6-item instrument to measure impairments over the past 7 days in both paid work and unpaid work due to one's health. Higher numbers indicate greater impairment and less productivity. Four main outcomes can be yielded from WPAI and are presented as percentages (0-100%).
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital🇺🇸Boston, Massachusetts, United StatesSharon Ng, MSContact617-525-7097shng1@mgh.harvard.eduSuzanne Bertisch, MD, MPHPrincipal Investigator