Sleep Disturbances Associated With MenopauseESTeeMNCT06728332
An Observational Study to Learn More About How Menopause Affects Women's Sleep and How They Are Being Treated for Sleep Problems
An observational study of Sleep Disturbances Associated With Menopause, run by Bayer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbances Associated With Menopause
- What is being tested?
- No study intervention
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2024to 27 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Females from 40 to 65 years (inclusive) experiencing sleep disturbances associated with menopause.
Who may be able to join
- Women experiencing menopause assigned female at birth, 40-65 years of age, residing in the United States.
- 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.
- Sleep disturbances due to menopause, defined as self-reported disturbances characterized by waking up at night and/or poor quality of sleep (including difficulty falling asleep, short sleep, waking up early).
- Signed ICF by the patient.
- Provided access to medical records, directly granting access through the HRS platform and the provider's portal or providing contact information and a medical records release form.
Who cannot join
- Menopause induced chemically or from radiation therapy (i.e., chemotherapy).
- Medical conditions that impact sleep, including diagnosed chronic insomnia, sleep apnea, restless leg syndrome, circadian rhythm sleep disorder; current or history (except complete remission for 5 years or more) of any malignancy (except basal and squamous cell skin tumors).
- Women self-reporting being under the care of a HCP for suicidal ideation in the past six months, clinical anxiety in the past six months, or clinical depression in the past six months.
- Patients participating in a clinical trial.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ESTeeM: Evaluation of Sleep Disturbances in Menopause
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.
Read more
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.
- Being tested
- No study intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No study interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Females experiencing sleep disturbances associated with menopause Receives: Other: No study intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of awakenings in the night.
Measured: 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
Measured: From Day 1 to Day 28
Mean number of moderate or severe hot flashes per night
Measured: From Day 1 to Day 28
Mean sleep efficiency score
Defined as the percentage of time spent asleep while in bed
Measured: From Day 1 to Day 28
Mean length of time (in minutes) to fall asleep
Measured: 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.
Measured: Day 1, Day 14 and Day 28
Menopause-specific quality-of-life questionnaire (MENQOL) total score
Measured by ePRO.
Measured: Day 1, Day 14 and Day 28
Insomnia Severity Index (ISI) total Score
Measured: Day 1, Day 14 and Day 28
Socioeconomic status short-form questionnaire
Measured: Day 0
Secondary outcomes (18)
Descriptive analysis of demographics
Measured: Day 0
Descriptive analysis of clinical characteristics
Measured: Day 0
Lifestyle questionnaire
Questionnaire includes smoking history, alcohol consumption, caffeine consumption, other persons in the home and work schedule.
Measured: Day 0
Comorbid conditions and dates of diagnosis from patient EHR (electronic health record)
Measured: Day 0
Concomitant medications, from patient medication survey
Measured: Day 0
Body mass index (BMI)
Measured: Day 0
Number of previous pregnancies from patient EHR
Measured: Day 0
Non-pharmacologic treatments for sleep disturbances
Measured: Day 0
Number of EHR (electronic Health record) documented prescriptions for sleep disturbances.
Measured: Retrospective analysis from 12 months prior to ICF
Number of patient-reported medications and supplements for sleep disturbances.
Measured: From 6 months prior Day 1
Number of patients reporting alternative treatment/management for sleep disturbances
Measured: Day 0
Questionnaire of satisfaction score for medications and supplements used to treat sleep disturbances.
Measured: 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.
Measured: Day 1 to Day 28
List of types of treatment formerly prescribed for sleep disturbances, from patient medication survey.
Measured: Day 0
Duration of treatments formerly prescribed for sleep disturbances, by drug class, from patient medication survey.
Measured: Day 0
Proportion of days PRN medication used.
Measured: From Day 1 to Day 28
Among medications for sleep disturbances discontinued within 6 months of enrollment, patient reported reason for discontinuation.
Measured: Day 0
HADS (Hospital Anxiety and Depression Scale) total score.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start6 Dec 2024
- Primary completion29 Aug 2025
- Study completion27 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disturbances Associated With MenopauseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728332
- Sponsor's protocol ID
- 22815
- Acronym
- ESTeeM
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESTeeM: Evaluation of Sleep Disturbances in Menopause
- ClinicalTrials.gov ID
- NCT06728332
- Acronym / sponsor ID
- ESTeeM / 22815
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 27 Oct 2025 (actual)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: No study interventionFemales experiencing sleep disturbances associated with menopause |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Females from 40 to 65 years (inclusive) experiencing sleep disturbances associated with menopause.
Key inclusion criteria (5 listed)
- Women experiencing menopause assigned female at birth, 40-65 years of age, residing in the United States.
- 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.
- Sleep disturbances due to menopause, defined as self-reported disturbances characterized by waking up at night and/or poor quality of sleep (including difficulty falling asleep, short sleep, waking up early).
- Signed ICF by the patient.
- Provided access to medical records, directly granting access through the HRS platform and the provider's portal or providing contact information and a medical records release form.
Key exclusion criteria (5 listed)
- Menopause induced chemically or from radiation therapy (i.e., chemotherapy).
- Medical conditions that impact sleep, including diagnosed chronic insomnia, sleep apnea, restless leg syndrome, circadian rhythm sleep disorder; current or history (except complete remission for 5 years or more) of any malignancy (except basal and squamous cell skin tumors).
- Women self-reporting being under the care of a HCP for suicidal ideation in the past six months, clinical anxiety in the past six months, or clinical depression in the past six months.
- Patients participating in a clinical trial.
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No study interventionNo 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. | Other | Group 1 |
Primary outcome
Number of awakenings in the night.
Time frame: From Day 1 to Day 28.
Mean WASO (wakefulness after sleep onset)
Time frame: From Day 1 to Day 28
Total number of minutes that a participant is awake after having initially fallen asleep
Mean number of moderate or severe hot flashes per night
Time frame: From Day 1 to Day 28
Mean sleep efficiency score
Time frame: From Day 1 to Day 28
Defined as the percentage of time spent asleep while in bed
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
Time frame: Day 1, Day 14 and Day 28
PROMIS-SD-SF-8B: Patient-reported Outcomes Measurement Information System Sleep disturbance short form 8b.
Menopause-specific quality-of-life questionnaire (MENQOL) total score
Time frame: Day 1, Day 14 and Day 28
Measured by ePRO.
Insomnia Severity Index (ISI) total Score
Time frame: Day 1, Day 14 and Day 28
Socioeconomic status short-form questionnaire
Time frame: Day 0
18 secondary outcomes
Descriptive analysis of demographics
Time frame: Day 0
Descriptive analysis of clinical characteristics
Time frame: Day 0
Lifestyle questionnaire
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disturbances Associated With Menopause, run by Bayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of awakenings in the night. (time frame: From Day 1 to Day 28.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.