Clinical trial NCT06728332: An Observational Study to Learn More About How Menopause Affects Women's Sleep and How They Are Being Treated for Sleep Problems
Official title: ESTeeM: Evaluation of Sleep Disturbances in Menopause
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Disturbances Associated With Menopause
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2024-12-11
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females from 40 to 65 years (inclusive) experiencing sleep disturbances associated with menopause.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of awakenings in the night.
timeFrame: From Day 1 to Day 28.
measure: Mean WASO (wakefulness after sleep onset)
timeFrame: From Day 1 to Day 28
measure: Mean number of moderate or severe hot flashes per night
timeFrame: From Day 1 to Day 28
measure: Mean sleep efficiency score
timeFrame: From Day 1 to Day 28
measure: Mean length of time (in minutes) to fall asleep
timeFrame: From Day 1 to Day 28
measure: Mean total sleep disturbance score (T-score) derived from PROMIS-SD-SF-8b
timeFrame: Day 1, Day 14 and Day 28
measure: Menopause-specific quality-of-life questionnaire (MENQOL) total score
timeFrame: Day 1, Day 14 and Day 28
measure: Insomnia Severity Index (ISI) total Score
timeFrame: Day 1, Day 14 and Day 28
measure: Socioeconomic status short-form questionnaire
timeFrame: Day 0
Secondary outcomes:
measure: Descriptive analysis of demographics
timeFrame: Day 0
measure: Descriptive analysis of clinical characteristics
timeFrame: Day 0
measure: Lifestyle questionnaire
timeFrame: Day 0
measure: Comorbid conditions and dates of diagnosis from patient EHR (electronic health record)
timeFrame: Day 0
measure: Concomitant medications, from patient medication survey
timeFrame: Day 0
measure: Body mass index (BMI)
timeFrame: Day 0
measure: Number of previous pregnancies from patient EHR
timeFrame: Day 0
measure: Non-pharmacologic treatments for sleep disturbances
timeFrame: Day 0
measure: Number of EHR (electronic Health record) documented prescriptions for sleep disturbances.
timeFrame: Retrospective analysis from 12 months prior to ICF
measure: Number of patient-reported medications and supplements for sleep disturbances.
timeFrame: From 6 months prior Day 1
measure: Number of patients reporting alternative treatment/management for sleep disturbances
timeFrame: Day 0
measure: Questionnaire of satisfaction score for medications and supplements used to treat sleep disturbances.
timeFrame: From 6 months prior Day 1
measure: Names of prescription and non-prescription medications and supplements for sleep disturbances reported in Daily Morning Diaries, including dosage.
timeFrame: Day 1 to Day 28
measure: List of types of treatment formerly prescribed for sleep disturbances, from patient medication survey.
timeFrame: Day 0
measure: Duration of treatments formerly prescribed for sleep disturbances, by drug class, from patient medication survey.
timeFrame: Day 0
measure: Proportion of days PRN medication used.
timeFrame: From Day 1 to Day 28
measure: Among medications for sleep disturbances discontinued within 6 months of enrollment, patient reported reason for discontinuation.
timeFrame: Day 0
measure: Mean HADS (Hospital Anxiety and Depression Scale) total score.
timeFrame: Day 0
Other outcomes:
Locations:
city: Whippany
country: United States
facility: Bayer
state: New Jersey
Study officials:
References: