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Home Diagnosis and Treatment of Obstructive Sleep Apnea

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

Condition Intervention
Obstructive Sleep Apnea Device: Continuous Positive Airway Pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Can Obstructive Sleep Apnea be Diagnosed at Home? A Randomised Trial of Home Diagnosis and Treatment of OSA.

Resource links provided by NLM:

Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Sleepiness score

Secondary Outcome Measures:
  • Quality of life
  • Vigilance tests
  • Sleep quality
  • CPAP compliance

Estimated Enrollment: 50
Study Start Date: November 2004
Study Completion Date: June 2007
Detailed Description:
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT00139022

Canada, Saskatchewan
Sleep Disorders Center, Royal Univerisity Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W0
Sponsors and Collaborators
University of Saskatchewan
Principal Investigator: Robert P Skomro, MD Univerisity of Saskatchewan
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00139022     History of Changes
Other Study ID Numbers: BIO-REB# 04-91
Study First Received: August 26, 2005
Last Updated: October 4, 2007

Keywords provided by University of Saskatchewan:
sleep apnea, home monitoring, CPAP

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases processed this record on August 18, 2017