HighCycle Study: Effect of Acetazolamide on Sleep Disordered Breathing in Women Compared to Men

University of Zurich (UZH)

Status and phase: Enrolling; Phase 4

Conditions: Sleep-Disordered Breathing

Treatments: Drug: Acetazolamide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06498531

HighCycle_SDB

Details and patient eligibility

About

Randomized clinical trial evaluating the effect of acetazolamide on sleep disordered breathing in women compared to men travelling to 3600 m.

Enrollment: 270 estimated patients

Sex: All

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy, non-smoking men and 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 women with an eumenorrheic cycle

Exclusion criteria

• Other types of contraceptvies (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

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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270 participants in 4 patient groups, including a placebo group

WOMEN - ACETAZOLAMIDE oral capsule

Active Comparator group

Description:

Acetazolamide 250 mg/day (capsules @125 mg; 1 in the morning, 1 in the evening), orally. Medication starts 24 hours before ascent to 3600 m until the morning after the second night at 3600 m.

Treatment:

Drug: Acetazolamide

MEN - ACETAZOLAMIDE oral capsule

Active Comparator group

Description:

Acetazolamide 250 mg/day (capsules @125 mg; 1 in the morning, 1 in the evening), orally. Medication starts 24 hours before ascent to 3600 m until the morning after the second night at 3600 m.

Treatment:

Drug: Acetazolamide

WOMEN - PLACEBO oral capsule

Placebo Comparator group

Description:

Placebo (capsules identically looking as acetazolamide capsules; 1 in the morning, 1 in the evening), orally. Medication starts 24 hours before ascent to 3600 m until the morning after the second night at 3600 m.

Treatment:

Drug: Placebo

MEN - PLACEBO oral capsule

Placebo Comparator group

Description:

Placebo (capsules identically looking as acetazolamide capsules; 1 in the morning, 1 in the evening), orally. Medication starts 24 hours before ascent to 3600 m until the morning after the second night at 3600 m.

Treatment:

Drug: Placebo