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

HighCycle Study: Effect of High Altitude on Acute Mountain Sickness in Women Related to Their Menstrual Cycle Phase: A Prospective Cohort Study at 3600 m

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06499714
Enrollment
91
Registered
2024-07-12
Start date
2024-07-15
Completion date
2025-08-31
Last updated
2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Mountain Sickness

Keywords

Women, Hypoxia, Prevention, Acetazolamide, Altitude

Brief summary

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

Interventions

Participants will travel to and stay for 2 days at an altitude of 3600 m.

Sponsors

University of Zurich
Lead SponsorOTHER
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
CollaboratorOTHER_GOV
University Hospital Heidelberg
CollaboratorOTHER
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Acute Mountain Sickness (AMS) Incidence, LLS 1993Day 1 to 3 at 3600 mMCP-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 2018Day 1 to 3 at 3600 mMCP-related difference on the AMS severity assessed by the Lake Louise Questionnaire version 2018.
Acute Mountain Sickness (AMS) Severity, LLS 1993Day 1 to 3 at 3600 mMCP-related difference on the AMS severity assessed by the Lake Louise Questionnaire version 1993.
Arterial blood gasesDay 2 at 760 m and day 2 at 3600 mMCP-related difference on the arterial blood gases (pH, PaO2, PaCO2, SaO2).
Hypoxic ventilatory responseDay 2 at 760 mMCP-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 visualizationDay 1 to 3 at 3600 mMCP-related difference on perceived pain sensations, visualized by the SMaRT tablet app

Countries

Kyrgyzstan

Contacts

STUDY_CHAIRMichael Furian, Prof. Dr.

University of Zurich

STUDY_DIRECTORTalant Sooronbaev, Prof. Dr.

National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026