HighCycle Study: Effect of High Altitude on Acute Mountain Sickness in Women Related to Their Menstrual Cycle Phase

Recruiting

• Conditions: Acute Mountain Sickness
• Interventions: Other: Exposure to 3600 m

• Registration Number: NCT06499714
• Lead Sponsor: University of Zurich

Brief Summary

Prospective cohort study investigating the menstrual cycle phase (MCP)-dependent incidence of acute mountain sickness (AMS) in women travelling to 3600 m.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-05
• Study First Submitted QC: 2024-07-11
• Last Update Submitted: 2024-07-11
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12
• Study Start: 2024-07-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Healthy, non-smoking women, age 18-44 years, without any disease and need of regular medication (including oral contraceptives).
• BMI >18 kg/m2 and <30 kg/m2
• Born, raised and currently living at altitudes <1000 m
• Written informed consent
• Premenopausal, eumenorrheic cycle

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Exclusion Criteria

• Other types of contraceptives (hormonal intrauterine device, vaginal ring, subcutaneous injections or implants, among others)
• Pregnancy or nursing
• Anaemic (haemoglobin concentration <10g/dl)
• Any altitude trip <4 weks before the study
• Allergy to acetazolamide and other sulfonamides

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women in luteal MCP	Exposure to 3600 m	Women being in their luteal MCP on the day of ascent to high altitude.
Women in follicular MCP	Exposure to 3600 m	Women being in their follicular MCP on the day of ascent to high altitude.

Primary Outcome Measures

Name	Time	Method
Acute Mountain Sickness (AMS) Incidence, LLS 2018	Day 1 to 3 at 3600 m	MCP-related difference in the AMS incidence. AMS incidence will be defined as a Lake Louise Questionnaire version 2018 score of ≥3.

Secondary Outcome Measures

Name	Time	Method
Acute Mountain Sickness (AMS) Severity, LLS 1993	Day 1 to 3 at 3600 m	MCP-related difference on the AMS severity assessed by the Lake Louise Questionnaire version 1993.
Arterial blood gases	Day 2 at 760 m and day 2 at 3600 m	MCP-related difference on the arterial blood gases (pH, PaO2, PaCO2, SaO2).
Hypoxic ventilatory response	Day 2 at 760 m	MCP-related difference in the hypoxic ventilatory response assessed under FiO2 of 0.115 and while cycling on a bicycle at 30% of predicted maximal work capacity.
Perceived pain visualization	Day 1 to 3 at 3600 m	MCP-related difference on perceived pain sensations, visualized by the SMaRT tablet app
Acute Mountain Sickness (AMS) Incidence, LLS 1993	Day 1 to 3 at 3600 m	MCP-related difference in the AMS incidence. AMS incidence will be defined as a Lake Louise Questionnaire version 1993 score of ≥3.
Acute Mountain Sickness (AMS) Severity, LLS 2018	Day 1 to 3 at 3600 m	MCP-related difference on the AMS severity assessed by the Lake Louise Questionnaire version 2018.

Trial Locations

Locations (1)

National Center for Cardiology and Internal Medicine; 🇰🇬 Bishkek, Kyrgyzstan