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

Effect of High Altitude Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730143
• Other study ID #: REB15-2709_V1
• Status: Completed
• Phase: N/A
• Start date: April 4, 2016
• Est. completion date: May 7, 2016

Study information

• Verified date: November 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 7, 2016
• Est. primary completion date: May 7, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Altitude Sickness
• Effect of High Altitude
• Respiratory Aspiration

Intervention

Other:
• Altitude exposure
Altitude exposure

Locations

Country	Name	City	State
Switzerland	University of Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	University of Calgary

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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	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	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	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	first sojourn at 5050 m, day 2, 7; second sojourn at 5050 m, day 2,7; low altitude sojourn at 520 m, day 2