Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-01-02 @ 5:13 AM
Study NCT ID:
NCT06728332
Status:
COMPLETED
Last Update Posted:
2025-11-25
First Post:
2024-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study to Learn More About How Menopause Affects Women's Sleep and How They Are Being Treated for Sleep Problems
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
ESTeeM: Evaluation of Sleep Disturbances in Menopause
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESTeeM
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: