- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02451020
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
Conditions
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
-
-
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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
Keywords
Additional Relevant MeSH Terms
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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