Study to Investigate Sleep Apnea Patients at Altitude

NCT ID: NCT00514826

Last Updated: 2010-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2007-10-31

Brief Summary

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

Detailed Description

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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

Conditions

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Obstructive Sleep Apnea Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

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altitude exposure

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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University Hospital of Zurich, Switzerland

Principal Investigators

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Konrad E. Bloch, MD

Role: STUDY_DIRECTOR

Pulmonary Division, University Hospital Zurich, Switzerland

Locations

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Pulmonary Division, University Hospital Zurich, Switzerland

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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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.2009.125849.

Reference Type RESULT
PMID: 20435865 (View on PubMed)

Bloch KE, Latshang TD, Turk AJ, Hess T, Hefti U, Merz TM, Bosch MM, Barthelmes D, Hefti JP, Maggiorini M, Schoch OD. Nocturnal periodic breathing during acclimatization at very high altitude at Mount Muztagh Ata (7,546 m). Am J Respir Crit Care Med. 2010 Aug 15;182(4):562-8. doi: 10.1164/rccm.200911-1694OC. Epub 2010 May 4.

Reference Type DERIVED
PMID: 20442435 (View on PubMed)

Other Identifiers

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EK1413

Identifier Type: -

Identifier Source: org_study_id

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