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Completed

NCT Number: NCT02730143

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

Prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure of high altitude on nocturnal breathing pattern.

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Key information

Conditions

Effect of High Altitude

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Zurich

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Altitude exposure

Other

Altitude exposure

Primary outcomes

  1. 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

  1. Apnea-/hypopnea index measured by respiratory polygraphy

    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 apnea-/hypopnea index over the course of high altitude exposure during 2 sojourns at 5050 m compared to low altitude

  2. Oxygen desaturation index measured by respiratory polygraphy

    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 oxygen desaturation index over the course of high altitude exposure during 2 sojourns at 5050 m compared to low altitude

  3. Acute mountain sickness measured by the Environmental Symptom questionnaire cerebral score (AMSc)

    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

    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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • University of Calgary

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 6, 2016
Registry last updated
Nov 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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