Back to resultsEffect of Acetazolamide on Sleep Disordered Breathing in Lowlanders Older Than 40 Years at Altitude
Primary Purpose
Altitude Hypoxia
Status
Completed
Phase
Phase 4
Locations
Kyrgyzstan
Study Type
Interventional
Intervention
ACETAZOLAMIDE oral capsule
Placebo oral capsule
Sponsored by
About this trial
This is an interventional prevention trial for Altitude Hypoxia focused on measuring healthy participants older than 40 years, sleep disordered breathing, periodic breathing, prevention, acetazolamide
Eligibility Criteria
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.
Sites / Locations
- National Center of Cardiology and Internal Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ACETAZOLAMIDE oral capsule
PLACEBO oral capsule
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in nocturnal oxygen saturation night 1 at 3'100m
Difference in altitude-induced change in mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group
Change in nocturnal oxygen saturation night 2 at 3'100m
Difference in altitude-induced change in mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group
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
Change in apnea/hypopnea index night 1 at 3'100m
Difference in altitude-induced change in mean number of apneas/hypopneas per hour between the acetazolamide and placebo group
Change in apnea/hypopnea index night 2 at 3'100m
Difference in altitude-induced change in mean number of apneas/hypopneas per hour between the acetazolamide and placebo group
Change in subjective sleepiness and sleep quality
Difference in altitude-induced change in subjective sleepiness and sleep quality assessed by a visual analog scale between acetazolamide and placebo group
Full Information
NCT ID
NCT03536507
First Posted
May 14, 2018
Last Updated
November 4, 2021
Sponsor
University of Zurich
Collaborators
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
1. Study Identification
Unique Protocol Identification Number
NCT03536507
Brief Title
Effect of Acetazolamide on Sleep Disordered Breathing in Lowlanders Older Than 40 Years at Altitude
Official Title
Effect of Acetazolamide on Sleep Disordered Breathing in Lowlanders Older Than 40 Years at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
August 2, 2018 (Actual)
Study Completion Date
August 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Altitude Hypoxia
Keywords
healthy participants older than 40 years, sleep disordered breathing, periodic breathing, prevention, acetazolamide
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACETAZOLAMIDE oral capsule
Arm Type
Active Comparator
Arm Description
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
Arm Title
PLACEBO oral capsule
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
ACETAZOLAMIDE oral capsule
Intervention Description
Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m
Primary Outcome Measure Information:
Title
Change in nocturnal oxygen desaturation index
Description
Difference in altitude-induced change in the mean number of cyclic dips in oxygen saturation measured by pulse oximetry between acetazolamide and placebo group
Time Frame
night 1 at 760m and night 1 at 3'100 m
Secondary Outcome Measure Information:
Title
Change in nocturnal oxygen saturation night 1 at 3'100m
Description
Difference in altitude-induced change in mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group
Time Frame
night 1 at 760m and night 1 at 3'100 m
Title
Change in nocturnal oxygen saturation night 2 at 3'100m
Description
Difference in altitude-induced change in mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group
Time Frame
night 1 at 760m and night 2 at 3'100 m
Title
Change in nocturnal oxygen desaturation index
Description
Difference in altitude-induced change in the mean number of cyclic dips in oxygen saturation measured by pulse oximetry between acetazolamide and placebo group
Time Frame
night 1 at 760m and night 2 at 3'100 m
Title
Change in apnea/hypopnea index night 1 at 3'100m
Description
Difference in altitude-induced change in mean number of apneas/hypopneas per hour between the acetazolamide and placebo group
Time Frame
night 1 at 760m and night 1 at 3'100 m
Title
Change in apnea/hypopnea index night 2 at 3'100m
Description
Difference in altitude-induced change in mean number of apneas/hypopneas per hour between the acetazolamide and placebo group
Time Frame
night 1 at 760m and night 2 at 3'100 m
Title
Change in subjective sleepiness and sleep quality
Description
Difference in altitude-induced change in subjective sleepiness and sleep quality assessed by a visual analog scale between acetazolamide and placebo group
Time Frame
Day 1 and 2 at 760m and 3'100m
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad E Bloch, MD
Organizational Affiliation
University Hospital, Zürich
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Talant M Sooronbaev, MD
Organizational Affiliation
National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michael Furian, MSc
Organizational Affiliation
University Hospital, Zürich
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center of Cardiology and Internal Medicine
City
Bishkek
ZIP/Postal Code
720040
Country
Kyrgyzstan
12. IPD Sharing Statement
Learn more about this trial
Effect of Acetazolamide on Sleep Disordered Breathing in Lowlanders Older Than 40 Years at Altitude
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