Actively Recruiting
Comparing and Predicting the Risk of Respiratory Tract Infection Among Postmenopausal Women With or Without Hormone Replacement Therapy Using Wearable Technology
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-12-18
400
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Respiratory tract infections (RTIs) are a significant health concern worldwide, causing substantial illness and disability. This study focuses on postmenopausal women aged 40 to 60 years to explore how hormone replacement therapy (HRT) may influence the frequency and severity of RTIs. The research aims to better understand risk factors for RTIs during menopause and evaluate how wearable technology can predict infection onset before symptoms appear. The study observes two groups of women: those taking HRT and those not taking HRT. Over six months, participants will wear a smartwatch to continuously monitor physiological data such as heart rate and sleep patterns. They will also complete questionnaires about lifestyle, medical history, and environmental exposure. RTI episodes will be tracked through self-reporting and confirmed by lab tests. Data analysis will use statistical and machine learning methods to identify predictors of RTI and develop an early-warning model. Participants will be followed for six months from enrollment, during which researchers will record the number and severity of RTI episodes. Wearable devices and questionnaires will provide ongoing data, while laboratory confirmation will validate infections. The study will assess daily individual risk of RTI onset and correlations between participant characteristics and infection outcomes. Findings aim to support personalized prevention strategies and improve respiratory health management in postmenopausal women.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biological sex: female
- Age between 40 and 60 years
- Voluntary informed consent given
- Fluent in German
- Willingness to wear a Garmin Vivosmart 5 smartwatch most of the time for six months
- Own a smartphone compatible with the Fitrockr application
- Confirmed postmenopausal status by either 12 or more months of spontaneous amenorrhea without other causes, 6 or more months of amenorrhea with biochemical confirmation, or bilateral oophorectomy at least 6 weeks before enrollment
You will not qualify if you...
- Unable to provide informed consent
- Known allergy to polycarbonate (material in smartwatch wristband)
- Poorly controlled asthma (ACT score less than 20 despite medication)
- Use of injectable asthma drugs with broad immune effects
- Coronary artery disease
- Diabetes mellitus diagnosis
- Cancer diagnosis
- Chronic kidney disease diagnosis
- Confirmed familial hypercholesterolemia (genetic)
- Sleep apnea treated with bi-level positive airway pressure
- Chronic rhinosinusitis
- Severe chronic obstructive pulmonary disease (stage 3 or 4) or interstitial lung disease with hospitalization for respiratory symptoms within the last 12 months
- Any condition or treatment deemed incompatible with study goals by the principal investigator
- Employment in the Gynecological Endocrinology and Reproductive Medicine section or relation to the principal investigator
- Concurrent participation in another clinical interventional study
- Technical inability to pair smartphone with smartwatch
- Inability to comply with study procedures due to language, psychiatric illness, or inability to attend visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants wear a Garmin Vivosmart 5 smartwatch and use a smartphone app to collect data on respiratory tract infections and related symptoms.
Continuous data collection using wearable technology and smartphone app
Trial Site Locations
Total: 1 location
1
University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
Bern, Switzerland, 3010
Actively Recruiting
Research Team
P
Petra Stute, Prof. Dr. med.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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