Home Diagnosis and Treatment of Obstructive Sleep Apnea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-06-30

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea

Keywords

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sleep apnea, home monitoring, CPAP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Continuous Positive Airway Pressure

Intervention Type DEVICE

Eligibility Criteria

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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

\-

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Robert P Skomro, MD

Role: PRINCIPAL_INVESTIGATOR

Univerisity of Saskatchewan

Locations

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Sleep Disorders Center, Royal Univerisity Hospital

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED

PMID: 20173052 (View on PubMed)

Other Identifiers

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BIO-REB# 04-91

Identifier Type: -

Identifier Source: org_study_id