Hormone replacement therapy and respiratory infection risk in postmenopausal women
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 (Meno_Flu)
Insel Gruppe AG, University Hospital Bern · NCT07292857
This project tests whether hormone replacement therapy changes the chance and severity of respiratory infections in postmenopausal women who wear a smartwatch for six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 40 Years to 60 Years |
| Sex | Female |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Locations | 1 site (Bern) |
| Trial ID | NCT07292857 on ClinicalTrials.gov |
What this trial studies
This is an observational cohort that follows postmenopausal women aged 40–60 to compare rates and severity of respiratory tract infections between those using hormone replacement therapy (HRT) and those not using HRT. Participants will wear a Garmin Vivosmart 5 and use a compatible smartphone app (Fitrockr) for most days over a six-month period to collect physiological and activity data, alongside clinical and questionnaire information. The study excludes people with major comorbidities such as uncontrolled asthma, diabetes, coronary artery disease, or active cancer to reduce confounding. Collected data will be used to compare outcomes by HRT status and to build predictive models of RTI risk.
Who should consider this trial
Good fit: Biological females aged 40–60 who are confirmed postmenopausal, fluent in German, willing to wear a Garmin Vivosmart 5 and use a compatible smartphone app, and who do not have the listed exclusion conditions.
Not a fit: Women with uncontrolled asthma, diabetes, coronary artery disease, active cancer, inability to wear the smartwatch or use the app, or who are not fluent in German are unlikely to be eligible or to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could clarify whether HRT alters infection risk and support more personalized monitoring or prevention for postmenopausal women.
How similar studies have performed: Wearable-based monitoring has shown promise for early infection detection in other populations, but the specific question of how HRT affects respiratory infection risk in postmenopausal women remains largely untested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Bern
- University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine — Bern, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Petra Stute, Prof. Dr. med. — Department of Obstetrics and Gynecology, University Hospital of Bern
- Study coordinator: Petra Stute, Prof. Dr. med.
- Email: petra.stute@insel.ch
- Phone: +41 31 632 1010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Menopausal Women, Respiratory Tract Infections, Hormone Replacement Therapy, Menopause, Health monitoring, Wearables, Infection risk