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

What this trial studies

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.

Conditions in scope

• Menopausal Women
• Respiratory Tract Infections (RTI)

Interventions

• Not specified in the public record.

Who can join

Women only · Ages 40 Years to 60 Years

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Observational
• Phase: N/A
• Start date: 2024-09-18
• Primary completion: 2025-12
• Last update posted: 2025-12-18
• First posted: 2025-12-18

Sponsor & contact

Lead sponsor: Insel Gruppe AG, University Hospital Bern (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Number of Respiratory Tract Infection (RTI) Episodes per Participant Over 6 Months (6 months from enrollment (per participant))
  Count of RTI episodes per participant during the 6-month observation period. An RTI episode is defined as the period beginning with participant-reported symptom onset and ending when: * all symptoms return to baseline, or * a maximum of 10 days of residual symptoms has elapsed. Symptom presence is documented via daily responses to the Wisconsin Upper Respiratory Symptoms Survey-21 (WURSS-21).
• Cumulative Symptom Severity Score of All RTI Episodes Over 6 Months (6 months from enrollment (per participant))
  Cumulative RTI severity, calculated as the sum of daily WURSS-21 scores across all RTI episodes occurring during the 6-month observation period. The WURSS-21 (Wisconsin Upper Respiratory Symptom Survey-21) is a validated instrument containing 21 items scored from 0 to 7 each: * 0 = "not at all" (no symptom / no functional impact) * 7 = "severe" Higher scores indicate…

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.