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

NCT06499714 | Recruiting

• 1 other identifier: HighCycle_AMS_MCP
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Mountain Sickness

Keywords

Women; Hypoxia; Prevention; Acetazolamide; Altitude

Outcome Measures

Primary Outcomes (1)

• Acute Mountain Sickness (AMS) Incidence, LLS 2018

  MCP-related difference in the AMS incidence. AMS incidence will be defined as a Lake Louise Questionnaire version 2018 score of ≥3.

  Day 1 to 3 at 3600 m

Secondary Outcomes (6)

• Acute Mountain Sickness (AMS) Incidence, LLS 1993

  Day 1 to 3 at 3600 m

• Acute Mountain Sickness (AMS) Severity, LLS 2018

  Day 1 to 3 at 3600 m

• Acute Mountain Sickness (AMS) Severity, LLS 1993

  Day 1 to 3 at 3600 m

• Arterial blood gases

  Day 2 at 760 m and day 2 at 3600 m

• Hypoxic ventilatory response

  Day 2 at 760 m

Study Arms (2)

Women in luteal MCP

Women being in their luteal MCP on the day of ascent to high altitude.

Other: Exposure to 3600 m

Women in follicular MCP

Women being in their follicular MCP on the day of ascent to high altitude.

Other: Exposure to 3600 m

Interventions

Exposure to 3600 m OTHER

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

Women in follicular MCP; Women in luteal MCP

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy, non-smoking, premenopausal women, age 18-44 years, without any disease and need of regular medication (including oral contraceptives).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov: collaborator
• University Hospital Heidelberg: collaborator
• Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques: collaborator

Study Sites (1)

National Center for Cardiology and Internal Medicine

Bishkek, Gorod Bishkek, 720040, Kyrgyzstan

RECRUITING

MeSH Terms

Conditions

Altitude Sickness; Hypoxia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Furian, Prof. Dr.

  University of Zurich

  STUDY CHAIR

• Talant Sooronbaev, Prof. Dr.

  National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

  STUDY DIRECTOR

Central Study Contacts

Michael Furian, Prof. Dr.

CONTACT

+41794037586; michael.furian@usz.ch

Talant Sooronbaev, Prof. Dr.

CONTACT

+996772574567; sooronbaev@yahoo.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 12, 2024
• Study Start: July 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-05

Locations

KY (1)