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Acclimatization of Healthy Subjects During a Stay at 3200 m

Primary Purpose

Effects of High Altitude

Status
Completed
Phase
Not Applicable
Locations
Kyrgyzstan
Study Type
Interventional
Intervention
Altitude exposure
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Effects of High Altitude focused on measuring healthy volunteers, acclimatization, sleep, hypoxia

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Perfect health
  • Born, raised and currently living at low altitude (<800m)
  • Informed consent.

Exclusion Criteria:

  • Any acute or chronic disease
  • heavy smoking (>20 cigarettes per day).

Sites / Locations

  • National Center of Cardiology and Internal Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Altitude exposure

Arm Description

Stay at 3200 m for 3 weeks

Outcomes

Primary Outcome Measures

Mean nocturnal oxygen saturation measured by pulse oximetry
Difference in mean nocturnal oxygen saturation between night 1 and night 7

Secondary Outcome Measures

Mean nocturnal oxygen saturation measured by pulse oximetry
Difference in mean nocturnal oxygen saturation between night 1 at 3200 and night 1 at 700 m
Mean nocturnal oxygen saturation measured by pulse oximetry
Difference in mean nocturnal oxygen saturation between night 21 and night 1 at 3200 m
Mean nocturnal oxygen saturation measured by pulse oximetry
Mean nocturnal oxygen saturation during night 1 at 700 m

Full Information

First Posted
May 18, 2015
Last Updated
October 29, 2018
Sponsor
University of Zurich
Collaborators
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
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1. Study Identification

Unique Protocol Identification Number
NCT02451020
Brief Title
Acclimatization of Healthy Subjects During a Stay at 3200 m
Official Title
Acclimatization of Healthy Subjects During a Stay at 3200 m
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 8, 2015 (Actual)
Primary Completion Date
August 9, 2015 (Actual)
Study Completion Date
August 9, 2015 (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

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study evaluates respiratory acclimatization in healthy lowlanders staying for 3 weeks at 3200 m.
Detailed Description
This study evaluates the effect of 3 weeks altitude acclimatization on sleep related breathing disturbances in healthy subjects staying at 3200 m. Participants living in Bishkek, Kyrgyzstan (700 m), will be transferred by car within 4 h to the Tuja Ashu high altitude clinic (3200 m). Outcomes will be assessed repeatedly during the stay at 3200 m.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effects of High Altitude
Keywords
healthy volunteers, acclimatization, sleep, hypoxia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Altitude exposure
Arm Type
Experimental
Arm Description
Stay at 3200 m for 3 weeks
Intervention Type
Other
Intervention Name(s)
Altitude exposure
Intervention Description
Participants will stay for 3 weeks at an altitude of 3200 m
Primary Outcome Measure Information:
Title
Mean nocturnal oxygen saturation measured by pulse oximetry
Description
Difference in mean nocturnal oxygen saturation between night 1 and night 7
Time Frame
night 7 at 3200 m
Secondary Outcome Measure Information:
Title
Mean nocturnal oxygen saturation measured by pulse oximetry
Description
Difference in mean nocturnal oxygen saturation between night 1 at 3200 and night 1 at 700 m
Time Frame
night 1 at 3200 m
Title
Mean nocturnal oxygen saturation measured by pulse oximetry
Description
Difference in mean nocturnal oxygen saturation between night 21 and night 1 at 3200 m
Time Frame
night 21 at 3200 m
Title
Mean nocturnal oxygen saturation measured by pulse oximetry
Description
Mean nocturnal oxygen saturation during night 1 at 700 m
Time Frame
night 1 at 700 m (low altitude baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Perfect health Born, raised and currently living at low altitude (<800m) Informed consent. Exclusion Criteria: Any acute or chronic disease heavy smoking (>20 cigarettes per day).
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
Facility Information:
Facility Name
National Center of Cardiology and Internal Medicine
City
Bishkek
ZIP/Postal Code
720040
Country
Kyrgyzstan

12. IPD Sharing Statement

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Acclimatization of Healthy Subjects During a Stay at 3200 m

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