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

Phase 4

Recruiting

• Conditions: Sleep-Disordered Breathing
• Interventions: Drug: Placebo; Drug: Acetazolamide

• Registration Number: NCT06498531
• Lead Sponsor: University of Zurich

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-05
• Study First Submitted QC: 2024-07-05
• Last Update Submitted: 2024-07-05
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12
• Study Start: 2024-07-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MEN - PLACEBO oral capsule	Placebo	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.
WOMEN - ACETAZOLAMIDE oral capsule	Acetazolamide	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.
MEN - ACETAZOLAMIDE oral capsule	Acetazolamide	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.
WOMEN - PLACEBO oral capsule	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Nocturnal oxygen desaturation index (ODI)	Night 1 at 760 m and Night 1 at 3600 m	Sex-related difference in the altitude-induced change in the ODI (number of ∆SpO2 \>3% per hour time in bed measured by pulse oximetry) between acetazolamide and placebo group.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Center for Cardiology and Internal Medicine; 🇰🇬 Bishkek, Kyrgyzstan