Home Diagnosis and Treatment of Obstructive Sleep Apnea

• Sponsor: University of Saskatchewan (Other)
• Overall Status: Completed
• CT.gov ID: NCT00139022
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Duration (Months): 30.9
• Patients Per Site Per Month: 1.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Device: Continuous Positive Airway Pressure	N/A

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

• Study Type: Interventional
• Anticipated 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: Nov 1, 2004
• Actual Study Completion Date: Jun 1, 2007

Outcome Measures

Primary Outcome Measures

1. Sleepiness score []

Secondary Outcome Measures

1. Quality of life []

2. Vigilance tests []

3. Sleep quality []

4. CPAP compliance []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	Sleep Disorders Center, Royal Univerisity Hospital	Saskatoon	Saskatchewan	Canada	S7N 0W0

Sponsors and Collaborators

• University of Saskatchewan

Investigators

• Principal Investigator: Robert P Skomro, MD, Univerisity of Saskatchewan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00139022
• Other Study ID Numbers: BIO-REB# 04-91
• First Posted: Aug 30, 2005
• Last Update Posted: Oct 10, 2007
• Last Verified: Feb 1, 2007

• Keywords provided by , ,: sleep apnea, home monitoring, CPAP
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Study Results

No Results Posted as of Oct 10, 2007