Effect of Acetazolamide on Sleep Disordered Breathing in Lowlanders Older Than 40 Years at Altitude

NCT03536507 | Completed Phase 4

• 1 other identifier: 2018-01-8/305C
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, placebo controlled trial evaluating the effect of acetazolamide on sleep disordered breathing in lowlanders older than 40 years travelling from 760 m to 3'100 m.

Conditions

Altitude Hypoxia

Keywords

healthy participants older than 40 years; sleep disordered breathing; periodic breathing; prevention; acetazolamide

Outcome Measures

Primary Outcomes (1)

• Change in nocturnal oxygen desaturation index

  Difference in altitude-induced change in the mean number of cyclic dips in oxygen saturation measured by pulse oximetry between acetazolamide and placebo group

  night 1 at 760m and night 1 at 3'100 m

Secondary Outcomes (6)

• Change in nocturnal oxygen saturation night 1 at 3'100m

  night 1 at 760m and night 1 at 3'100 m

• Change in nocturnal oxygen saturation night 2 at 3'100m

  night 1 at 760m and night 2 at 3'100 m

• Change in nocturnal oxygen desaturation index

  night 1 at 760m and night 2 at 3'100 m

• Change in apnea/hypopnea index night 1 at 3'100m

  night 1 at 760m and night 1 at 3'100 m

• Change in apnea/hypopnea index night 2 at 3'100m

  night 1 at 760m and night 2 at 3'100 m

Study Arms (2)

ACETAZOLAMIDE oral capsule

ACTIVE COMPARATOR

Acetazolamide 375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m

Drug: ACETAZOLAMIDE oral capsule

PLACEBO oral capsule

PLACEBO COMPARATOR

Placebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m

Drug: Placebo oral capsule

Interventions

ACETAZOLAMIDE oral capsule DRUG

Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m

ACETAZOLAMIDE oral capsule

Placebo oral capsule DRUG

Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m

PLACEBO oral capsule

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy men and women, age 40-75 yrs, without any disease and need of medication.
• Born, raised and currently living at low altitude (\<800m).
• Written informed consent.
• Kyrgyz ethnicity

You may not qualify if:

• Any active respiratory, cardiovascular or other disease requiring regular treatment or being otherwise relevant for tolerance of hypoxia or altitude exposure.
• Any condition that may interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day or \>20 pack-years with active smoking during the last 10 years), regular use of alcohol.
• 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

Study Sites (1)

National Center of Cardiology and Internal Medicine

Bishkek, 720040, Kyrgyzstan

Location

MeSH Terms

Conditions

Altitude Sickness; Sleep Apnea Syndromes

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Konrad E Bloch, MD

  University Hospital, Zürich

  STUDY CHAIR

• Talant M Sooronbaev, MD

  National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

  STUDY DIRECTOR

• Michael Furian, MSc

  University Hospital, Zürich

  PRINCIPAL INVESTIGATOR

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: May 14, 2018
• First Posted: May 24, 2018
• Study Start: May 15, 2018
• Primary Completion: August 2, 2018
• Study Completion: August 2, 2018
• Last Updated: November 5, 2021

Record last verified: 2021-11

Locations

KY (1)