Status:
RECRUITING
Comparing and Predicting the Risk of Respiratory Tract Infection (RTI) Among Post-menopausal Women on or Without Hormone Replacement Therapy (HRT): an Observational Cohort Study
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Menopausal Women
Respiratory Tract Infections (RTI)
Eligibility:
FEMALE
40-60 years
Brief Summary
Background: Respiratory tract infections (RTIs) are a major public health concern. Global studies published in Lancet Infect. Dis. highlight the persistent morbidity and mortality from RTIs, with uppe...
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)
Key Trial Info
Start Date :
September 18 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT07292857
Start Date
September 18 2024
End Date
March 1 2026
Last Update
December 18 2025
Active Locations (1)
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1
University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
Bern, Switzerland, 3010