Bayer
Whippany, New Jersey, 07981, United States
NCT Number: NCT06728332
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.
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Notify Me40 year–65 year
Female
Observational
Whippany, New Jersey, 07981, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
o Where being in the menopausal period is defined as at least 12 months of spontaneous amenorrhea prior to index date (the date informed consent was signed) or surgical bilateral oophorectomy with or without hysterectomy at least 6 weeks prior to index date.
Exclusion criteria
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.
Time frame: From Day 1 to Day 28.
Time frame: From Day 1 to Day 28
Total number of minutes that a participant is awake after having initially fallen asleep
Time frame: From Day 1 to Day 28
Time frame: From Day 1 to Day 28
Defined as the percentage of time spent asleep while in bed
Time frame: From Day 1 to Day 28
Time frame: Day 1, Day 14 and Day 28
PROMIS-SD-SF-8B: Patient-reported Outcomes Measurement Information System Sleep disturbance short form 8b.
Time frame: Day 1, Day 14 and Day 28
Measured by ePRO.
Time frame: Day 1, Day 14 and Day 28
Time frame: Day 0
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Questionnaire includes smoking history, alcohol consumption, caffeine consumption, other persons in the home and work schedule.
Time frame: Day 0
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Time frame: Retrospective analysis from 12 months prior to ICF
Time frame: From 6 months prior Day 1
Time frame: Day 0
Time frame: From 6 months prior Day 1
Time frame: Day 1 to Day 28
Time frame: Day 0
Time frame: Day 0
Time frame: From Day 1 to Day 28
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Time frame: Day 0
Bayer
Industry
ESTeeM: Evaluation of Sleep Disturbances in Menopause
Acronym: ESTeeM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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