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

University of Zurich (UZH)

Status: Enrolling

Conditions: Sleep-Disordered Breathing

Treatments: Other: Exposure to 3600 m

Study type: Observational

Funder types: Other

Identifiers

NCT06498544

HighCycle_SDB_MCP

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

90 participants in 2 patient groups

Women in luteal MCP

Description:

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

Treatment:

Other: Exposure to 3600 m

Women in follicular MCP

Description:

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

Treatment:

Other: Exposure to 3600 m