Study to Investigate Sleep Apnea Patients at Altitude

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00514826
First received: August 9, 2007
Last updated: May 25, 2010
Last verified: May 2010
  Purpose

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


Condition Intervention
Obstructive Sleep Apnea Syndrome
Other: altitude exposure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Study to Investigate Sleep Apnea Patients at Altitude

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Prevalence and severity of sleep disordered breathing [ Time Frame: during altitude sojourn ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • alterations in sleep structure and vigilance; high altitude related illness [ Time Frame: during altitude sojourn ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: altitude exposure
    sojourn at moderate altitude (1860m and 2590m) during 2 days/nights each
Detailed 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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514826

Locations
Switzerland
Pulmonary Division, University Hospital Zurich, Switzerland
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: Konrad E. Bloch, MD Pulmonary Division, University Hospital Zurich, Switzerland
  More Information

Publications:
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Konrad E. Bloch, Professor, MD, University Hospital of Zurich, Switzerland
ClinicalTrials.gov Identifier: NCT00514826     History of Changes
Other Study ID Numbers: EK1413
Study First Received: August 9, 2007
Last Updated: May 25, 2010
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 23, 2014