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 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT07292857
Eligibility Criteria:
Inclusion Criteria:
* Biological sex: female
* Age: 40-60 years
* Self-determined decision to participate, confirmed by signing the informed consent form (ICF)
* Fluent in German
* Agreement to wear a smartwatch (Garmin Vivosmart 5) for most of the time over six months
* Ownership of a smartphone compatible with the Fitrockr application
* Confirmed post-menopausal status: Spontaneous amenorrhea for ≥12 consecutive months without other causes OR ≥6 months of spontaneous amenorrhea with biochemical confirmation (FSH \> 40 IU/L OR FSH \> 30 IU/L for women aged ≥50 using hormonal contraception) OR bilateral oophorectomy ≥6 weeks before enrollment
Exclusion Criteria:
* Inability to provide informed consent
* Known allergic reaction to polycarbonate (smartwatch wristband material)
* Asthma not well-controlled (ACT score \<20 despite medication)
* Use of injectable asthma drugs with broad immunomodulatory activity
* Coronary artery disease
* Diagnosis of diabetes mellitus
* Cancer diagnosis
* Diagnosis of chronic kidney disease
* Confirmed diagnosis of familial hypercholesterolemia (genetic)
* Sleep apnea managed with bi-level positive airway pressure (PAP)
* Chronic rhinosinusitis
* Severe (stage 3 or 4) chronic obstructive pulmonary disease (COPD) or interstitial lung disease with hospitalization within the prior 12 months for respiratory symptoms
* Any other condition/treatment deemed incompatible with the study objectives by the PI or delegated co-investigators
* Current employment in the Section of Gynecological Endocrinology and Reproductive Medicine (Inselspital Bern) or any other relation to the principal investigator
* Concurrent participation in a clinical interventional study
* Technical inability to pair the participant's smartphone with the smartwatch
* Inability to comply with study procedures (e.g., due to language, psychiatric illness, or inability to attend study site)
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
60 Years
Study:
NCT07292857
Study Brief:
Protocol Section:
NCT07292857