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

NCT06498531 | Recruiting Phase 4

• 1 other identifier: HighCycle_SDB
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep-Disordered Breathing

Keywords

Sleep disordered breathing; Periodic breathing; Prevention; Acetazolamide; Altitude; Hypoxia; Women

Outcome Measures

Primary Outcomes (1)

• Nocturnal oxygen desaturation index (ODI)

  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.

  Night 1 at 760 m and Night 1 at 3600 m

Secondary Outcomes (7)

• Nocturnal oxygen saturation (SpO2)

  Night 1 at 760 m and Night 1 at 3600 m

• Nocturnal oxygen saturation (SpO2)

  Night 1 at 760 m and Night 2 at 3600 m

• Apnea/hypopnea index (AHI)

  Night 1 at 760 m and Night 1 at 3600 m

• Apnea/hypopnea index (AHI)

  Night 1 at 760 m and Night 2 at 3600 m

• Subjective sleep quality

  Night 1 at 760 m and Night 1 at 3600 m

Study Arms (4)

WOMEN - ACETAZOLAMIDE oral capsule

ACTIVE COMPARATOR

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.

Drug: Acetazolamide

MEN - ACETAZOLAMIDE oral capsule

ACTIVE COMPARATOR

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.

Drug: Acetazolamide

WOMEN - PLACEBO oral capsule

PLACEBO COMPARATOR

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.

Drug: Placebo

MEN - PLACEBO oral capsule

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Acetazolamide DRUG

Administration of 1x125mg acetazolamide in the morning, 1x125mg in the evening, starting 24 hours before departure to 3600 m.

MEN - ACETAZOLAMIDE oral capsule; WOMEN - ACETAZOLAMIDE oral capsule

Placebo DRUG

Administration of equally looking placebo capsules in the morning and in the evening, starting 24 hours before departure to 3600 m.

MEN - PLACEBO oral capsule; WOMEN - PLACEBO oral capsule

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov: collaborator
• University Hospital Heidelberg: collaborator
• Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques: collaborator

Study Sites (1)

National Center for Cardiology and Internal Medicine

Bishkek, Gorod Bishkek, 720040, Kyrgyzstan

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Hypoxia

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Michael Furian, Prof. Dr.

  University of Zurich

  STUDY CHAIR

• Talant Sooronbaev, Prof. Dr.

  National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

  STUDY DIRECTOR

Central Study Contacts

Michael Furian, Prof. Dr.

CONTACT

+41794037586; michael.furian@usz.ch

Talant Sooronbaev, Prof. Dr.

CONTACT

+996772574567; sooronbaev@yahoo.ru

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 12, 2024
• Study Start: July 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-05

Locations

KY (1)