Home Diagnosis and Treatment of Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by:
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT00139022
First received: August 26, 2005
Last updated: October 4, 2007
Last verified: February 2007

August 26, 2005
October 4, 2007
November 2004
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Sleepiness score
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Complete list of historical versions of study NCT00139022 on ClinicalTrials.gov Archive Site
  • Quality of life
  • Vigilance tests
  • Sleep quality
  • CPAP compliance
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Home Diagnosis and Treatment of Obstructive Sleep Apnea
Can Obstructive Sleep Apnea be Diagnosed at Home? A Randomised Trial of Home vs.in-Lab Diagnosis and Treatment of OSA.

Obstructive Sleep Apnea (OSA) is a common and underrecognised condition. The diagnosis of OSA is typically made after an in-lab polysomnography (PSG) which requires an overnight stay in a sleep laboratory. Many sleep laboratories have long waiting lists for PSG. There are a number of portable devices which may be useful in home diagnosis of OSA, however there is limited data on outcomes of OSA diagnosed and treated at home. In this study we propose to compare diagnostic accuracy of a home monitoring device with a PSG and outcomes of OSA therapy when implemented at home vs in the sleep laboratory.

We will randomise patients suspected to have OSA to either home evaluation and treatment (using a portable monitor and auto-CPAP) or in-lab evaluation with a PSG and manually-titrated CPAP. We will obtain sleep, sleepiness and quality of life questionnaires, vigilance testing and blood pressure at baseline and after 1, 2, 4 and 12 weeks of therapy. We will also assess and compare compliance with CPAP therapy in each arm of the study.

Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obstructive Sleep Apnea
Device: Continuous Positive Airway Pressure
Not Provided
Skomro RP, Gjevre J, Reid J, McNab B, Ghosh S, Stiles M, Jokic R, Ward H, Cotton D. Outcomes of home-based diagnosis and treatment of obstructive sleep apnea. Chest. 2010 Aug;138(2):257-63. doi: 10.1378/chest.09-0577. Epub 2010 Feb 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2007
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Inclusion Criteria:

  • adult ( age > 18)
  • suspected OSA
  • no coexisting heart or lung disease
  • not in a safety-sensitive occupation

Exclusion Criteria:

-

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00139022
BIO-REB# 04-91
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University of Saskatchewan
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Principal Investigator: Robert P Skomro, MD Univerisity of Saskatchewan
University of Saskatchewan
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP