Menopausal WomenMeno_FluNCT07292857
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
An observational study of Menopausal Women and Respiratory Tract Infections (RTI), run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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 upper- and lower-RTIs collectively accounting for more than 100 million disability-adjusted-life-years per year. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Menopausal Women, Respiratory Tract Infections (RTI)
- How many people
- 400 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Sep 2024to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Adult
Study population: This study targets post-menopausal women aged 40-60 years, recruited from the University Hospital (Inselspital Bern), affiliated clinics, and the general public in Switzerland. Participants will be assigned to two observational cohorts based on their use of hormone replacement therapy (HRT vs. no HRT).
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
Bern, 3010
Petra Stute, Prof. Dr. med., +41 31 632 1010, petra.stute@insel.ch
Petra Stute, Prof. Dr. med.
About this study
Official 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 (Meno_Flu)
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.
Read more
Objective: This observational cohort study aims to compare and predict the risk of RTI among postmenopausal women, with a particular focus on the influence of HRT. The principal aim is to compare the rates and severity of respiratory tract infections in postmenopausal women taking or not taking HRT. The secondary aims are to characterize risk factors for RTI in postmenopausal women and identify signals in wearable data that predict the onset of an RTI before symptoms become apparent.
Methods: 400 women aged 40-60 will be studied, stratified into two groups: postmenopausal women taking HRT, and postmenopausal women not taking HRT. Participants will each be followed for six months, with RTI episodes recorded through self-reporting and confirmed by laboratory tests. Wearable devices will continuously monitor physiological parameters (e.g., heart rate, sleep patterns), and questionnaires will assess lifestyle factors, medical history, and environmental exposure. Statistical modeling and machine learning approaches will be used to analyze infection predictors and develop a model that predicts the risk of onset of an RTI.
Impact: Half of the world's population inevitably undergoes menopause, and this important life transition has wide-ranging impacts on women's health and quality of life for decades. Studies show that women spend more of their lives in poor health than men, with far-reaching impacts on a woman's participation in society, career performance, and ability to care for other family members. A better understanding of risk factors for respiratory infections in menopausal women and whether hormone-replacement therapy influences RTIs will contribute much-needed knowledge to enable better health management strategies for women. Furthermore, an "early-warning" system based on wearable signals will provide a valuable tool for quick intervention and to reduce the spread of infectious illnesses. Such an "early-warning" system will subsequently be tested for applicability across a broader representation of society as a preventive health measure and tool for pandemic preparedness.
Conclusion: Findings will enhance understanding of RTI risk and management in menopausal women and contribute to the development of personalized prevention strategies. Future applications include a wearable-based medical device for real-time RTI risk assessment, potentially reducing antibiotic overuse and improving healthcare efficiency. By enabling early detection and risk stratification, this study paves the way for a proactive and personalized approach to respiratory health in postmenopausal women, ultimately shifting the focus to prevention.
- Keywords
- Hormone Replacement Therapy, Menopause, Health monitoring, Wearables, Infection risk
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| post-menopausal women on hormone replacement therapy (HRT) | Not described | |
| post-menopausal women without hormone replacement therapy (HRT) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Respiratory Tract Infection (RTI) Episodes per Participant Over 6 Months
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).
Measured: 6 months from enrollment (per participant)
Cumulative Symptom Severity Score of All RTI Episodes Over 6 Months
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 worse symptoms and greater functional impairment.
Per-episode scoring begins on the first day of participant-reported symptom onset and continues until resolution or up to 10 days of persistent residual symptoms.
Measured: 6 months from enrollment (per participant)
Secondary outcomes (4)
Daily Individual Probability of Respiratory Tract Infection (RTI) Onset Based on Integrated Participant-Level and Environmental Data
For each participant and each study day, a continuous RTI-risk probability (unit: probability, 0-1) will be generated by statistical/machine-learning models.
Predictors include:
- wearable-derived physiological parameters (resting heart rate, respiration rate, sleep phase durations, step count, stress index)
- questionnaire-derived behavioral, psychosocial, medical, and social variables
- laboratory-measured biological variables (e.g., hormone concentrations, in original units) environmental/epidemiological variables (temperature [°C], humidity [%], PM10 [µg/m³], circulating respiratory viruses detected in national surveillance).
Unit of Measure: Probability (0-1) per participant per day.
Measured: 6 months after enrollment (per participant)
Correlation Between Participant-Level Characteristics and Number of RTI Episodes
The RTI count is defined as the number of RTI episodes per participant over 6 months, as ascertained through:
- daily WURSS-21 reporting,
- Jackson-scale symptom onset rules,
- nasal swab confirmation when available.
For each participant characteristic (predictor), the association will be quantified via regression coefficients from generalized linear models with Poisson distribution.
Predictors include:
- biological measures (e.g., hormone concentrations, in pg/mL or IU/L),
- medical history variables (binary/continuous),
- psychosocial questionnaire scales (e.g., PHQ-9 score, 0-27),
- lifestyle/behavior measures (sleep duration from wearable, minutes/day; step - count/day; stress index score 1-100),
- social context variables (household size: number of cohabitants).
Unit of Measure: Regression coefficient (unitless) per predictor describing effect on RTI count.
Measured: Time Frame: 6 months after enrollment (per participant)
Correlation Between Participant-Level Characteristics and Cumulative RTI Severity
Cumulative RTI severity is defined as the sum of daily WURSS-21 scores (range 0-140 per day) across all RTI days during the 6-month observation period.
Associations with participant characteristics will be quantified as regression coefficients from generalized linear models assuming a Tweedie compound-Poisson distribution.
Predictor variables and measurement tools (same categories as 4):
- hormone concentrations (IU/L or pg/mL),
- medical history variables,
- psychosocial scales (PHQ-9),
- lifestyle/behavior variables (sleep, steps, stress index),
- social context variables (household size).
Unit of Measure: Regression coefficient (unitless) per predictor describing effect on cumulative WURSS-21 severity score.
Measured: 6 months after enrollment (per participant)
Aggregate Pre-Symptomatic Deviation of Physiological and Questionnaire-Derived Signals During the 14 Days Prior to RTI Symptom Onset
For each confirmed RTI episode, wearable-derived parameters and weekly questionnaire variables will be evaluated in the 14 days preceding the first reported RTI symptoms (WURSS-21 start date).
The following raw indicators will be extracted but converted into standardized deviations relative to each participant's personal 30-day baseline (unit: z-score, unitless):
- resting heart rate (beats/min),
- respiration rate (breaths/min),
- sleep structure (minutes in REM/light/deep),
- stress index (1-100 score),
- step count (steps/day),
- participant-reported stress level (Likert scale),
- sleep quality (Likert scale),
- lifestyle behaviors (binary/ordinal). These will be aggregated into one composite pre-symptomatic deviation score, calculated as the mean z-standardized deviation of all included signals across the 14-day pre-onset window.
Unit of Measure: Composite standardized deviation score (unitless z-score).
Measured: 6 months after enrollment (per participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start18 Sep 2024
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal WomenStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petra Stute, Prof. Dr. med., Principal investigator, Department of Obstetrics and Gynecology, University Hospital of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292857
- Sponsor's protocol ID
- 2024-01182
- Acronym
- Meno_Flu
- Status last verified
- Dec 2025
- First submitted
- 20 May 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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 (Meno_Flu)
- ClinicalTrials.gov ID
- NCT07292857
- Acronym / sponsor ID
- Meno_Flu / 2024-01182
- Keywords
- Hormone Replacement Therapy, Menopause, Health monitoring, Wearables, Infection risk
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 influence of HRT. The principal aim is to compare the rates and severity of respiratory tract infections in postmenopausal women taking or not taking HRT. The secondary aims are to characterize risk factors for RTI in postmenopausal women and identify signals in wearable data that predict the onset of an RTI before symptoms become apparent.
Methods: 400 women aged 40-60 will be studied, stratified into two groups: postmenopausal women taking HRT, and postmenopausal women not taking HRT. Participants will each be followed for six months, with RTI episodes recorded through self-reporting and confirmed by laboratory tests. Wearable devices will continuously monitor physiological parameters (e.g., heart rate, sleep patterns), and questionnaires will assess lifestyle factors, medical history, and environmental exposure. Statistical modeling and machine learning approaches will be used to analyze infection predictors and develop a model that predicts the risk of onset of an RTI.
Impact: Half of the world's population inevitably undergoes menopause, and this important life transition has wide-ranging impacts on women's health and quality of life for decades. Studies show that women spend more of their lives in poor health than men, with far-reaching impacts on a woman's participation in society, career performance, and ability to care for other family members. A better understanding of risk factors for respiratory infections in menopausal women and whether hormone-replacement therapy influences RTIs will contribute much-needed knowledge to enable better health management strategies for women. Furthermore, an "early-warning" system based on wearable signals will provide a valuable tool for quick intervention and to reduce the spread of infectious illnesses. Such an "early-warning" system will subsequently be tested for applicability across a broader representation of society as a preventive health measure and tool for pandemic preparedness.
Conclusion: Findings will enhance understanding of RTI risk and management in menopausal women and contribute to the development of personalized prevention strategies. Future applications include a wearable-based medical device for real-time RTI risk assessment, potentially reducing antibiotic overuse and improving healthcare efficiency. By enabling early detection and risk stratification, this study paves the way for a proactive and personalized approach to respiratory health in postmenopausal women, ultimately shifting the focus to prevention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| post-menopausal women on hormone replacement therapy (HRT) | – | – |
| post-menopausal women without hormone replacement therapy (HRT) | – | – |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- This study targets post-menopausal women aged 40-60 years, recruited from the University Hospital (Inselspital Bern), affiliated clinics, and the general public in Switzerland. Participants will be assigned to two observational cohorts based on their use of hormone replacement therapy (HRT vs. no HRT).
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Respiratory Tract Infection (RTI) Episodes per Participant Over 6 Months
Time frame: 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
Time frame: 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 worse symptoms and greater functional impairment. Per-episode scoring begins on the first day of participant-reported symptom onset and continues until resolution or up to 10 days of persistent residual symptoms.
4 secondary outcomes
Daily Individual Probability of Respiratory Tract Infection (RTI) Onset Based on Integrated Participant-Level and Environmental Data
Time frame: 6 months after enrollment (per participant)
Correlation Between Participant-Level Characteristics and Number of RTI Episodes
Time frame: Time Frame: 6 months after enrollment (per participant)
Correlation Between Participant-Level Characteristics and Cumulative RTI Severity
Time frame: 6 months after enrollment (per participant)
Aggregate Pre-Symptomatic Deviation of Physiological and Questionnaire-Derived Signals During the 14 Days Prior to RTI Symptom Onset
Time frame: 6 months after enrollment (per participant)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Petra Stute, Prof. Dr. med. principal investigator
Department of Obstetrics and Gynecology, University Hospital of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopausal Women and Respiratory Tract Infections (RTI), run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petra Stute, Prof. Dr. med. (+41 31 632 1010, petra.stute@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Respiratory Tract Infection (RTI) Episodes per Participant Over 6 Months (time frame: 6 months from enrollment (per participant)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.