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NCT06728332 · ClinicalTrials.gov registry record
An Observational Study to Learn More About How Menopause Affects Women's Sleep and How They Are Being Treated for Sleep Problems
A clinical trial, sponsored by Bayer.
- Completed
- Registry status
- 750
- Enrollment target
NCT06728332 is a clinical trial that has completed, run by Bayer. The registered enrollment target is 750 participants.
The verdict
NCT06728332 has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- 750 participants
- Enrollment target
Study Summary
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.
Interventions
- OTHER No study intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 750 participants |
| Start Date | 2024-12-06 |
| Est. Completion | 2025-10-27 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06728332
The ClinicalTrials.gov registry entry for NCT06728332 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 750 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which No study intervention is the first listed.
NCT06728332 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06728332 about?
NCT06728332 is a clinical study titled "An Observational Study to Learn More About How Menopause Affects Women's Sleep and How They Are Being Treated for Sleep Problems". 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, ...
What is the current status of trial NCT06728332?
This trial is currently completed. The enrollment target is 750 participants. The study started on 2024-12-06. Estimated completion is 2025-10-27.
What interventions are being tested in trial NCT06728332?
The interventions under investigation include: No study intervention (OTHER).
Who is sponsoring clinical trial NCT06728332?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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