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HighCycle Study: Effect of High Altitude on Sleep Disordered Breathing in Women Related to Their Menstrual Cycle Phase

HighCycle Study: Effect of High Altitude on Sleep Disordered Breathing 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
NCT06498544
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

Sleep-Disordered Breathing

Keywords

Periodic breathing, Hypoxia, Prevention, Acetazolamide, Women, Altitude

Brief summary

Prospective cohort study investigating the menstrual cycle phase (MCP) dependent sleep disordered breathing (SDB) in women travelling to 3600 m.

Interventions

Participants will travel to and stay for 2 nights 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

Criteria: Inclusion Criteria: * 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

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
Nocturnal oxygen saturation (SpO2)Night 1 at 760 m and Night 1 at 3600 mMCP-related difference in altitude-induced change in the mean nocturnal oxygen saturation measured by pulse oximetry.

Secondary

MeasureTime frameDescription
Nocturnal oxygen desaturation index (ODI)Night 1 at 760 m and Night 1 at 3600 mMCP-related difference in altitude-induced change in the ODI (number of ∆SpO2 \>3% per hour time in bed measured by pulse oximetry).
Apnea/hypopnea index (AHI)Night 1 at 760 m and Night 1 at 3600 mMCP-related difference in altitude-induced change in the mean number of apneas/hypopneas per hour.
Subjective sleep qualityNight 1 at 760 m and Night 1 at 3600 mMCP-related difference in altitude-induced change in subjective sleep quality assessed by a 100-mm visual analog scale.
Nocturnal oxygen saturation (SpO2)Night 1 at 760 m and Night 2 at 3600 mMCP-related difference in altitude-induced change in the mean nocturnal oxygen saturation measured by pulse oximetry.

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