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.
Insomnia, or trouble sleeping, is common. It affects about 1 in 10 adults. People with insomnia are not happy with how long or how well they sleep. Insomnia has been linked to a higher risk of depression, heart disease, memory problems, and lower quality of life. It can also lead to missing work and having accidents. Sleep problems like insomnia are also common or people going through perimenopause and post-menopause. CBT-I teaches people to change behaviors and thoughts that make it hard to sleep. Daridorexant is an FDA-approved medicine for insomnia. Trazodone is FDA-approved to treat depression, but many doctors also prescribe it to help with sleep. This is called off-label use, which means it is used for a purpose the FDA has not officially approved. Studies show that trazodone is one of the most common medicines prescribed for insomnia in the United States. We do not yet know how well CBT-I, trazodone, and daridorexant compare, especially for people in perimenopause and post-menopause. 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: Consent telephone or virtual call Screening Visit: Baseline surveys, urine pregnancy test, electrocardiogram, 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 out diaries 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. 1-week and 4-weeks Call: Quick phone call with study staff for any study treatment adjustments. 3-Months and 6-Months Call/Visit: Fill out surveys. At 6-months, weight will be measured. During the visit window, 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 for a total of 7 days. 9-Months Call: Quick phone call with study staff to see if there are any issues. 12-Months Call/Visit: Fill out surveys. During the visit window, 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 for a total of 7 days. The Fitbit is for the participant to keep and does not have to be returned.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,000
This 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 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 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.
Brigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGHenry Ford Medical Center
Novi, Michigan, United States
NOT_YET_RECRUITINGAtrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
NOT_YET_RECRUITINGUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
NOT_YET_RECRUITINGUniversity of Utah
Salt Lake City, Utah, United States
NOT_YET_RECRUITINGPROMIS 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 Months
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 months
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 months
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 months
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 months
Occurrences of events of special interest and/or adverse events
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
Time frame: Throughout the study duration (up to 1 year)
Number of awakenings
Measure of number of awakenings per night by Fitbit.
Time frame: 6 months
Sleep duration
Measured by Fitbit, in hours and minutes.
Time frame: 6 months
PROMIS Depression Scale
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.
Time frame: 6 months
PROMIS Anxiety Scale
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.
Time frame: 6 months
PROMIS Cognitive Function Abilities Scale
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.
Time frame: 6 months
PROMIS Anger Scale
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.
Time frame: 6 months
PROMISE Global Health Score
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.
Time frame: 6 months
PROMIS Fatigue Score
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.
Time frame: 6 months
PROMIS Interest in Sexual Activity Score
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.
Time frame: 6 months
PROMIS Satisfaction with Sex Life Score
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.
Time frame: 6 months
Menopause-related Quality of Life
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.
Time frame: 6 months
Work Productivity and Activity Impairment
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%).
Time frame: 6 months
Insomnia Severity Index
The Insomnia Severity Index will be used and the possible range of raw score is 0-28. A higher score means more severe symptoms of insomnia.
Time frame: 6 months
PROMIS Pain Interference
The PROMIS pain interference scale will be used and the possible range of raw score is 4-20. A higher score means higher levels of pain.
Time frame: 6 months
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