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Effect of High Altitude Exposure, Acclimatization and Re-exposure on Nocturnal Breathing Pattern in Lowlanders

Primary Purpose

Effect of High Altitude

Status
Completed
Phase
Not Applicable
Locations
Switzerland
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 prevention trial for Effect of High Altitude focused on measuring Altitude, Nocturnal breathing pattern

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • born, raised and currently living <800m
  • No overnight stay at altitudes >1500 m 4 weeks before the study

Exclusion Criteria:

  • Previous altitude intolerance to altitude <3000 m
  • Pregnancy
  • Health impairment, which requires regular treatment

Sites / Locations

  • University of Zurich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Altitude exposure

Arm Description

Acute high altitude exposure followed by 8 day acclimatization and re-exposure after 6 days at low altitude

Outcomes

Primary Outcome Measures

Mean nocturnal oxygen saturation measured by pulse oximetry
Change in mean nocturnal oxygen saturation over the course of high altitude exposure during 2 sojourns at 5050 m compared to low altitude

Secondary Outcome Measures

Apnea-/hypopnea index measured by respiratory polygraphy
Change in apnea-/hypopnea index over the course of high altitude exposure during 2 sojourns at 5050 m compared to low altitude
Oxygen desaturation index measured by respiratory polygraphy
Change in oxygen desaturation index over the course of high altitude exposure during 2 sojourns at 5050 m compared to low altitude
Acute mountain sickness measured by the Environmental Symptom questionnaire cerebral score (AMSc)
Incidence of acute mountain sickness (AMSc score >= 0.7) over the course of high altitude exposure during 2 sojourns at 5050 m compared to low altitude

Full Information

First Posted
March 31, 2016
Last Updated
November 8, 2018
Sponsor
University of Zurich
Collaborators
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT02730143
Brief Title
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Nocturnal Breathing Pattern in Lowlanders
Official Title
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Nocturnal Breathing Pattern in Lowlanders
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 4, 2016 (Actual)
Primary Completion Date
May 7, 2016 (Actual)
Study Completion Date
May 7, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
University of Calgary

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure of high altitude on nocturnal breathing pattern.
Detailed Description
Respiratory polygraphies will be performed in Santiago de Chile, 520 m, over the course of 3 days. Participants will then travel by commercial airline (5 h flight) and by bus (3 h ride) to the ALMA base camp located at 2900 m near San Pedro de Atacama, northern Chile. Participants will stay there for the next 7 nights and respiratory polygraphies will be performed on night 1 and 6. They will be spend the days (6-8 h daily) at the telescope station at 5050 m while undergoing physiological testing. Daily transports from 2900 to 5050 m will be by car (1 h ride, one way). After the first 8 day altitude sojourn participants will return to the Santiago area (520 m) for a 6 day recovery period. A second altitude sojourn with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of High Altitude
Keywords
Altitude, Nocturnal breathing pattern

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Altitude exposure
Arm Type
Experimental
Arm Description
Acute high altitude exposure followed by 8 day acclimatization and re-exposure after 6 days at low altitude
Intervention Type
Other
Intervention Name(s)
Altitude exposure
Intervention Description
Altitude exposure
Primary Outcome Measure Information:
Title
Mean nocturnal oxygen saturation measured by pulse oximetry
Description
Change in mean nocturnal oxygen saturation over the course of high altitude exposure during 2 sojourns at 5050 m compared to low altitude
Time Frame
first sojourn at 5050 m, night 1, 6; second sojourn at 5050 m, night 1, 6; low altitude sojourn at 520 m, night 1
Secondary Outcome Measure Information:
Title
Apnea-/hypopnea index measured by respiratory polygraphy
Description
Change in apnea-/hypopnea index over the course of high altitude exposure during 2 sojourns at 5050 m compared to low altitude
Time Frame
first sojourn at 5050 m, night 1, 6; second sojourn at 5050 m, night 1, 6; low altitude sojourn at 520 m, night 1
Title
Oxygen desaturation index measured by respiratory polygraphy
Description
Change in oxygen desaturation index over the course of high altitude exposure during 2 sojourns at 5050 m compared to low altitude
Time Frame
first sojourn at 5050 m, night 1, 6; second sojourn at 5050 m, night 1, 6; low altitude sojourn at 520 m, night 1
Title
Acute mountain sickness measured by the Environmental Symptom questionnaire cerebral score (AMSc)
Description
Incidence of acute mountain sickness (AMSc score >= 0.7) over the course of high altitude exposure during 2 sojourns at 5050 m compared to low altitude
Time Frame
first sojourn at 5050 m, day 2, 7; second sojourn at 5050 m, day 2,7; low altitude sojourn at 520 m, day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: born, raised and currently living <800m No overnight stay at altitudes >1500 m 4 weeks before the study Exclusion Criteria: Previous altitude intolerance to altitude <3000 m Pregnancy Health impairment, which requires regular treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad E Bloch, MD
Organizational Affiliation
University of Zurich
Official's Role
Study Chair
Facility Information:
Facility Name
University of Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of High Altitude Exposure, Acclimatization and Re-exposure on Nocturnal Breathing Pattern in Lowlanders

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