This is an observational study in which data from women with sleep disturbances and vasomotor symptoms, also known as hot flashes, associated with menopause (SDM) are collected and studied. Menopause is part of a natural aging process and happens when women's menstrual cycles, also called periods, stop. Sleep disturbances, such as frequent waking up at night, are a common symptom (clinical sign) and a major worry associated with menopause that affects women's quality of life. The participants will continue to take their regular treatment for their SDM as agreed with their doctors. These are called "standard of care" treatments. Because both patients and doctors don't know much about SDM, women are often treated with sleep medicines that can lead to addiction and cause side effects. This study will help us to learn more about how much menopause-related sleep problems affect a woman's overall health and well-being. We also want to find out how women are currently being treated or treat themselves for these sleep problems, so we can figure out if there's a need for new treatments that focus specifically on menopause-related sleep issues To do this, researchers will collect information on: * the number of times a woman wakes up during the night and the total time she is awake after she first falls asleep * the time when a woman goes to bed and when she wakes up in the morning * how long it takes for a woman to fall asleep after going to bed * changes in sleep problem questionnaire scores to assess how these problems affect a woman's quality of life The data will come from combining all the electronic health record databases, patient related questionnaires, and data from smartwatches that the women will wear on their wrists. The data will be collected between November 2024 to May 2025. In this study, researchers will combine all the electronic data during a 28-day follow-up period. No visits or tests are required as part of this study.
Study Type
OBSERVATIONAL
Enrollment
750
No visits or examinations, laboratory tests or procedures are mandated or required for this study. Providers in the study recruitment network will recruit eligible patients through an existing visit. After this referral, the study is conducted entirely electronically.
Bayer
Whippany, New Jersey, United States
Number of awakenings in the night.
Time frame: From Day 1 to Day 28.
Mean WASO (wakefulness after sleep onset)
Total number of minutes that a participant is awake after having initially fallen asleep
Time frame: From Day 1 to Day 28
Mean number of moderate or severe hot flashes per night
Time frame: From Day 1 to Day 28
Mean sleep efficiency score
Defined as the percentage of time spent asleep while in bed
Time frame: From Day 1 to Day 28
Mean length of time (in minutes) to fall asleep
Time frame: From Day 1 to Day 28
Mean total sleep disturbance score (T-score) derived from PROMIS-SD-SF-8b
PROMIS-SD-SF-8B: Patient-reported Outcomes Measurement Information System Sleep disturbance short form 8b.
Time frame: Day 1, Day 14 and Day 28
Menopause-specific quality-of-life questionnaire (MENQOL) total score
Measured by ePRO.
Time frame: Day 1, Day 14 and Day 28
Insomnia Severity Index (ISI) total Score
Time frame: Day 1, Day 14 and Day 28
Socioeconomic status short-form questionnaire
Time frame: Day 0
Descriptive analysis of demographics
Time frame: Day 0
Descriptive analysis of clinical characteristics
Time frame: Day 0
Lifestyle questionnaire
Questionnaire includes smoking history, alcohol consumption, caffeine consumption, other persons in the home and work schedule.
Time frame: Day 0
Comorbid conditions and dates of diagnosis from patient EHR (electronic health record)
Time frame: Day 0
Concomitant medications, from patient medication survey
Time frame: Day 0
Body mass index (BMI)
Time frame: Day 0
Number of previous pregnancies from patient EHR
Time frame: Day 0
Non-pharmacologic treatments for sleep disturbances
Time frame: Day 0
Number of EHR (electronic Health record) documented prescriptions for sleep disturbances.
Time frame: Retrospective analysis from 12 months prior to ICF
Number of patient-reported medications and supplements for sleep disturbances.
Time frame: From 6 months prior Day 1
Number of patients reporting alternative treatment/management for sleep disturbances
Time frame: Day 0
Questionnaire of satisfaction score for medications and supplements used to treat sleep disturbances.
Time frame: From 6 months prior Day 1
Names of prescription and non-prescription medications and supplements for sleep disturbances reported in Daily Morning Diaries, including dosage.
Time frame: Day 1 to Day 28
List of types of treatment formerly prescribed for sleep disturbances, from patient medication survey.
Time frame: Day 0
Duration of treatments formerly prescribed for sleep disturbances, by drug class, from patient medication survey.
Time frame: Day 0
Proportion of days PRN medication used.
Time frame: From Day 1 to Day 28
Among medications for sleep disturbances discontinued within 6 months of enrollment, patient reported reason for discontinuation.
Time frame: Day 0
HADS (Hospital Anxiety and Depression Scale) total score.
Time frame: Day 0
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