Study to Investigate Sleep Apnea Patients at Altitude

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:

Study to Investigate Sleep Apnea Patients at Altitude

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00514826
• Other study ID #: EK1413
• Status: Completed
• Phase: N/A
• First received: August 9, 2007
• Last updated: May 25, 2010
• Start date: August 2007
• Est. completion date: October 2007

Study information

• Verified date: May 2010
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to investigate the effect of an altitude sojourn on patients with the obstructive sleep apnea syndrome

Description:

Previous observations do not allow to draw firm conclusions on the effect of altitude sojourn on sleep, breathing and daytime performance in patients with the obstructive sleep apnea syndrome. Furthermore, the susceptibility of sleep apnea patients to high altitude related illness is not known. Therefore, the purpose is to study untreated patients with obstructive sleep apnea syndrome living at low altitude during a sojourn of a few days at moderate altitude in order to evaluate the physiologic effects of hypobaric hypoxia in these patients. We hypothesize that: 1. Sleep and nocturnal breathing disturbances in untreated OSA patients are more pronounced at moderate altitude compared to low altitude. 2. The increase in sleep related breathing disturbances at moderate altitude is due to an increase in central apnea/hypopnea

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Obstructive sleep apnea syndrome based on symptoms and a sleep study

Exclusion Criteria:

• Sleep disorders other than obstructive sleep apnea syndrome

• Other than mild, stable cardiovascular disease

• Other than mild lung disease

• Chronic rhinitis, previous uvulopalatopharyngoplasty

• Treatment with drugs that affect respiratory center drive

• Internal, neurologic or psychiatric disease that interferes with sleep quality

• Previous intolerance to moderate or low altitude < 2600m

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• altitude exposure
sojourn at moderate altitude (1860m and 2590m) during 2 days/nights each

Locations

Country	Name	City	State
Switzerland	Pulmonary Division, University Hospital Zurich, Switzerland	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Nussbaumer-Ochsner Y, Schuepfer N, Ulrich S, Bloch KE. Exacerbation of sleep apnoea by frequent central events in patients with the obstructive sleep apnoea syndrome at altitude: a randomised trial. Thorax. 2010 May;65(5):429-35. doi: 10.1136/thx.2009.125 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence and severity of sleep disordered breathing		during altitude sojourn	No
Secondary	alterations in sleep structure and vigilance; high altitude related illness		during altitude sojourn	No