HighCycle Study: Effect of High Altitude on Sleep Disordered Breathing in Women Related to Their Menstrual Cycle Phase
1 other identifier
observational
90
1 country
1
Brief Summary
Prospective cohort study investigating the menstrual cycle phase (MCP) dependent sleep disordered breathing (SDB) in women travelling to 3600 m.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2024
CompletedFirst Posted
Study publicly available on registry
July 12, 2024
CompletedStudy Start
First participant enrolled
July 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJune 13, 2025
June 1, 2025
1.5 years
July 5, 2024
June 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Nocturnal oxygen saturation (SpO2)
MCP-related difference in altitude-induced change in the mean nocturnal oxygen saturation measured by pulse oximetry.
Night 1 at 760 m and Night 1 at 3600 m
Secondary Outcomes (7)
Nocturnal oxygen desaturation index (ODI)
Night 1 at 760 m and Night 1 at 3600 m
Nocturnal oxygen desaturation index (ODI)
Night 1 at 760 m and Night 2 at 3600 m
Apnea/hypopnea index (AHI)
Night 1 at 760 m and Night 1 at 3600 m
Apnea/hypopnea index (AHI)
Night 1 at 760 m and Night 2 at 3600 m
Subjective sleep quality
Night 1 at 760 m and Night 1 at 3600 m
- +2 more secondary outcomes
Study Arms (2)
Women in luteal MCP
Women being in their luteal MCP on the day of ascent to high altitude.
Women in follicular MCP
Women being in their follicular MCP on the day of ascent to high altitude.
Interventions
Participants will travel to and stay for 2 nights at an altitude of 3600 m.
Eligibility Criteria
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 diseases 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Center for Cardiology and Internal Medicine
Bishkek, Gorod Bishkek, 720040, Kyrgyzstan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Furian, Prof. Dr.
University of Zurich
- STUDY DIRECTOR
Talant Sooronbaev, Prof. Dr.
National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
Central Study Contacts
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: 2025-06