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Clinical Trials/NCT02730143
NCT02730143CompletedNot Applicable

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

University of Zurich1 site in 1 country21 target enrollmentStarted: April 4, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
Mean nocturnal oxygen saturation measured by pulse oximetry

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Altitude exposure

Experimental

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

Intervention: Altitude exposure (Other)

Outcomes

Primary Outcomes

Mean nocturnal oxygen saturation measured by pulse oximetry

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

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

Secondary Outcomes

  • Acute mountain sickness measured by the Environmental Symptom questionnaire cerebral score (AMSc)(first sojourn at 5050 m, day 2, 7; second sojourn at 5050 m, day 2,7; low altitude sojourn at 520 m, day 2)
  • Oxygen desaturation index measured by respiratory polygraphy(first sojourn at 5050 m, night 1, 6; second sojourn at 5050 m, night 1, 6; low altitude sojourn at 520 m, night 1)
  • Apnea-/hypopnea index measured by respiratory polygraphy(first sojourn at 5050 m, night 1, 6; second sojourn at 5050 m, night 1, 6; low altitude sojourn at 520 m, night 1)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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