Acclimatization of Healthy Subjects During a Stay at 3200 m

October 29, 2018 updated by: University of Zurich
The study evaluates respiratory acclimatization in healthy lowlanders staying for 3 weeks at 3200 m.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bishkek, Kyrgyzstan, 720040
        • National Center of Cardiology and Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Altitude exposure
Stay at 3200 m for 3 weeks
Participants will stay for 3 weeks at an altitude of 3200 m

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean nocturnal oxygen saturation measured by pulse oximetry
Time Frame: night 7 at 3200 m
Difference in mean nocturnal oxygen saturation between night 1 and night 7
night 7 at 3200 m

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean nocturnal oxygen saturation measured by pulse oximetry
Time Frame: night 1 at 3200 m
Difference in mean nocturnal oxygen saturation between night 1 at 3200 and night 1 at 700 m
night 1 at 3200 m
Mean nocturnal oxygen saturation measured by pulse oximetry
Time Frame: night 21 at 3200 m
Difference in mean nocturnal oxygen saturation between night 21 and night 1 at 3200 m
night 21 at 3200 m
Mean nocturnal oxygen saturation measured by pulse oximetry
Time Frame: night 1 at 700 m (low altitude baseline)
Mean nocturnal oxygen saturation during night 1 at 700 m
night 1 at 700 m (low altitude baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2015

Primary Completion (Actual)

August 9, 2015

Study Completion (Actual)

August 9, 2015

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

May 20, 2015

First Posted (Estimate)

May 21, 2015

Study Record Updates

Last Update Posted (Actual)

October 30, 2018

Last Update Submitted That Met QC Criteria

October 29, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • EK15-2015_V2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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