account_circleRecruiting
Sleep Disturbances associated with menopause
Bayer Identifier:
22815
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
An Observational Study to Learn more about How Menopause Affects Women's Sleep and How They Are Being Treated for Sleep Problems
Trial purpose
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.
Key Participants Requirements
Sex
FemaleAge
40 - 65 YearsTrial summary
Enrollment Goal
1000Trial Dates
December 2024 - May 2025Phase
N/ACould I Receive a placebo
NoProducts
No DrugAccepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | Bayer | Whippany, 07981, US |
Primary Outcome
- Number of awakenings in the night.date_rangeTime 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 asleepdate_rangeTime Frame:From Day 1 to Day 28
- Mean number of moderate or severe hot flashes per nightdate_rangeTime Frame:From Day 1 to Day 28
- Mean sleep efficiency scoreDefined as the percentage of time spent asleep while in beddate_rangeTime Frame:From Day 1 to Day 28
- Mean length of time (in minutes) to fall asleepdate_rangeTime Frame:From Day 1 to Day 28
- Mean total sleep disturbance score (T-score) derived from PROMIS-SD-SF-8bPROMIS-SD-SF-8B: Patient-reported Outcomes Measurement Information System Sleep disturbance short form 8b.date_rangeTime Frame:Day 1, Day 14 and Day 28
- Menopause-specific quality-of-life questionnaire (MENQOL) total scoreMeasured by ePRO.date_rangeTime Frame:Day 1, Day 14 and Day 28
- Insomnia Severity Index (ISI) total Scoredate_rangeTime Frame:Day 1, Day 14 and Day 28
- Socioeconomic status short-form questionnairedate_rangeTime Frame:Day 0
Secondary Outcome
- Descriptive analysis of demographicsdate_rangeTime Frame:Day 0
- Descriptive analysis of clinical characteristicsdate_rangeTime Frame:Day 0
- Lifestyle questionnaireQuestionnaire includes smoking history, alcohol consumption, caffeine consumption, other persons in the home and work schedule.date_rangeTime Frame:Day 0
- Comorbid conditions and dates of diagnosis from patient EHR (electronic health record)date_rangeTime Frame:Day 0
- Concomitant medications, from patient medication surveydate_rangeTime Frame:Day 0
- Body mass index (BMI)date_rangeTime Frame:Day 0
- Number of previous pregnancies from patient EHRdate_rangeTime Frame:Day 0
- Non-pharmacologic treatments for sleep disturbancesdate_rangeTime Frame:Day 0
- Number of EHR (electronic Health record) documented prescriptions for sleep disturbances.date_rangeTime Frame:Retrospective analysis from 12 months prior to ICF
- Number of patient-reported medications and supplements for sleep disturbances.date_rangeTime Frame:From 6 months prior Day 1
- Number of patients reporting alternative treatment/management for sleep disturbancesdate_rangeTime Frame:Day 0
- Questionnaire of satisfaction score for medications and supplements used to treat sleep disturbances.date_rangeTime 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.date_rangeTime Frame:Day 1 to Day 28
- List of types of treatment formerly prescribed for sleep disturbances, from patient medication survey.date_rangeTime Frame:Day 0
- Duration of treatments formerly prescribed for sleep disturbances, by drug class, from patient medication survey.date_rangeTime Frame:Day 0
- Proportion of days PRN medication used.date_rangeTime Frame:From Day 1 to Day 28
- Among medications for sleep disturbances discontinued within 6 months of enrollment, patient reported reason for discontinuation.date_rangeTime Frame:Day 0
- Mean HADS (Hospital Anxiety and Depression Scale) total score.date_rangeTime Frame:Day 0
Trial design
Trial Type
ObservationalIntervention Type
OtherTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A