Study to Investigate Sleep Apnea Patients at Altitude
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of the study is to investigate the effect of an altitude sojourn on patients with the obstructive sleep apnea syndrome
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2007
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 9, 2007
CompletedFirst Posted
Study publicly available on registry
August 10, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedMay 26, 2010
May 1, 2010
2 months
August 9, 2007
May 25, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Prevalence and severity of sleep disordered breathing
during altitude sojourn
Secondary Outcomes (1)
alterations in sleep structure and vigilance; high altitude related illness
during altitude sojourn
Interventions
sojourn at moderate altitude (1860m and 2590m) during 2 days/nights each
Eligibility Criteria
You may qualify if:
- Obstructive sleep apnea syndrome based on symptoms and a sleep study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pulmonary Division, University Hospital Zurich, Switzerland
Zurich, CH-8091, Switzerland
Related Publications (2)
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.
PMID: 20435865RESULTBloch 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.
PMID: 20442435DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Konrad E. Bloch, MD
Pulmonary Division, University Hospital Zurich, Switzerland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 9, 2007
First Posted
August 10, 2007
Study Start
August 1, 2007
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
May 26, 2010
Record last verified: 2010-05