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Home Diagnosis and Treatment of Obstructive Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00139022
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : October 10, 2007
Sponsor:
Information provided by:
University of Saskatchewan

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Continuous Positive Airway Pressure Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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 vs.in-Lab Diagnosis and Treatment of OSA.
Study Start Date : November 2004
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Sleepiness score

Secondary Outcome Measures :
  1. Quality of life
  2. Vigilance tests
  3. Sleep quality
  4. CPAP compliance

Eligibility Criteria
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Information from the National Library of Medicine

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

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139022


Locations
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Canada, Saskatchewan
Sleep Disorders Center, Royal Univerisity Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W0
Sponsors and Collaborators
University of Saskatchewan
Investigators
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Principal Investigator: Robert P Skomro, MD Univerisity of Saskatchewan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00139022    
Other Study ID Numbers: BIO-REB# 04-91
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: October 10, 2007
Last Verified: February 2007
Keywords provided by University of Saskatchewan:
sleep apnea, home monitoring, CPAP
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases