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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Page 1 of 1 (1 locations)

1

University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine

Bern, Switzerland, 3010

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 | DecenTrialz