Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT06728332
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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT06728332
Study Brief:
Protocol Section:
NCT06728332