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Home Diagnosis and Treatment of Obstructive Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring sleep apnea, home monitoring, CPAP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sleep Disorders Center, Royal Univerisity Hospital

Outcomes

Primary Outcome Measures

Sleepiness score

Secondary Outcome Measures

Quality of life
Vigilance tests
Sleep quality
CPAP compliance

Full Information

First Posted
August 26, 2005
Last Updated
October 4, 2007
Sponsor
University of Saskatchewan
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1. Study Identification

Unique Protocol Identification Number
NCT00139022
Brief Title
Home Diagnosis and Treatment of Obstructive Sleep Apnea
Official Title
Can Obstructive Sleep Apnea be Diagnosed at Home? A Randomised Trial of Home vs.in-Lab Diagnosis and Treatment of OSA.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Saskatchewan

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
sleep apnea, home monitoring, CPAP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure
Primary Outcome Measure Information:
Title
Sleepiness score
Secondary Outcome Measure Information:
Title
Quality of life
Title
Vigilance tests
Title
Sleep quality
Title
CPAP compliance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult ( age > 18) suspected OSA no coexisting heart or lung disease not in a safety-sensitive occupation Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P Skomro, MD
Organizational Affiliation
Univerisity of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Disorders Center, Royal Univerisity Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W0
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20173052
Citation
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.
Results Reference
derived

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Home Diagnosis and Treatment of Obstructive Sleep Apnea

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