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

NCT ID: NCT03536507

Last Updated: 2021-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-15

Study Completion Date

2018-08-02

Brief Summary

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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.

Detailed Description

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This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of preventive acetazolamide intake on the sleep disordered breathing in lowlanders older than 40 years travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3'100 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3'100 m.

An interim analysis will be carried out when 80 participants will have completed the study or after the first year. The Peto's method will be used and the trial will be stopped when pre-specified futility boundaries were crossed.

Conditions

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Altitude Hypoxia

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ACETAZOLAMIDE oral capsule

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

Group Type ACTIVE_COMPARATOR

ACETAZOLAMIDE oral capsule

Intervention Type DRUG

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

PLACEBO oral capsule

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

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

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

Interventions

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ACETAZOLAMIDE oral capsule

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

Intervention Type DRUG

Placebo oral capsule

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

OTHER_GOV

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Konrad E Bloch, MD

Role: STUDY_CHAIR

University Hospital, Zürich

Talant M Sooronbaev, MD

Role: STUDY_DIRECTOR

National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

Michael Furian, MSc

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Zürich

Locations

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National Center of Cardiology and Internal Medicine

Bishkek, , Kyrgyzstan

Site Status

Countries

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Kyrgyzstan

Other Identifiers

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2018-01-8/305C

Identifier Type: -

Identifier Source: org_study_id