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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

Recruitingn/aAges 40 Years - 60 YearsFemaleInsel Gruppe AG, University Hospital Bern
NCT07292857 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 upper- and lower-RTIs collectively accounting for more than 100 million disability-adjusted-life-years per year. During menopause, hormonal changes alongside other factors increase the risk for illnesses, such as RTIs, COPD, cardiovascular disease, and diabetes. However, it remains unknown how hormone-replacement therapy during menopause might impact the frequency or severity of RTIs. While hormone replacement therapy (HRT) is often prescribed for menopausal symptom relief, its potential impact on RTI risk and severity has not been examined. Objective: This observational cohort study aims to compare and predict the risk of RTI among postmenopausal women, with a particular focus on the influenc

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📋 Eligibility rules (as published)
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)
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What it tests

  • Not listed
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Where

1 site
University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
Bern, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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