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

University of Zurich90 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Sleep-Disordered Breathing

Interventions

Exposure to 3600 mOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 44 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

National Center for Cardiology and Internal Medicine

Bishkek, Gorod Bishkek, Kyrgyzstan

RECRUITING

Outcomes

Primary Outcomes

Nocturnal oxygen saturation (SpO2)

MCP-related difference in altitude-induced change in the mean nocturnal oxygen saturation measured by pulse oximetry.

Time frame: Night 1 at 760 m and Night 1 at 3600 m

Secondary Outcomes

Nocturnal oxygen desaturation index (ODI)

MCP-related difference in altitude-induced change in the ODI (number of ∆SpO2 \>3% per hour time in bed measured by pulse oximetry).

Time frame: Night 1 at 760 m and Night 1 at 3600 m

Nocturnal oxygen desaturation index (ODI)

MCP-related difference in altitude-induced change in the ODI (number of ∆SpO2 \>3% per hour time in bed measured by pulse oximetry).

Time frame: Night 1 at 760 m and Night 2 at 3600 m

Apnea/hypopnea index (AHI)

MCP-related difference in altitude-induced change in the mean number of apneas/hypopneas per hour.

Time frame: Night 1 at 760 m and Night 1 at 3600 m

Apnea/hypopnea index (AHI)

MCP-related difference in altitude-induced change in the mean number of apneas/hypopneas per hour.

Time frame: Night 1 at 760 m and Night 2 at 3600 m

Subjective sleep quality

MCP-related difference in altitude-induced change in subjective sleep quality assessed by a 100-mm visual analog scale.

Time frame: Night 1 at 760 m and Night 1 at 3600 m

Subjective sleep quality

MCP-related difference in altitude-induced change in subjective sleep quality assessed by a 100-mm visual analog scale.

Central Contacts

Michael Furian, Prof. Dr.

CONTACT

+41794037586 michael.furian@usz.ch

Talant Sooronbaev, Prof. Dr.

CONTACT

+996772574567 sooronbaev@yahoo.ru

Data from ClinicalTrials.gov

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