Clinical Trial: Home Diagnosis and Treatment of Obstructive Sleep Apnea
This study is currently recruiting patients.
Verified by University of Saskatchewan July 2005
| Sponsored by: | University of Saskatchewan | | Information provided by: | University of Saskatchewan | | ClinicalTrials.gov Identifier: | NCT00139022 | |
Purpose
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 |
Obtructive Sleep Apnea
| Device: Continuous Positive Airway Pressure
|
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Can Obstructive Sleep Apnea Be Diagnosed at Home? A Randomised Trial of Home Vs.in-Lab Diagnosis and Treatment of OSA.
Further Study Details:
Expected Total Enrollment: 50
We will randomise patients suspected to have OSA to either home evaulation and treatment ( using a portbale monitor and auto-CPAP)or in-lab evaluation with a PSG and manually-titrated CPAP. We will obtain sleep, sleepiness and
quality of life questionnires, 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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- adult ( age > 18)
- suspected OSA
- no coexiting heart or lung disease
- not in a safety-sensitive occupation
Exclusion Criteria:
-
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00139022
Robert P Skomro, MD 306-966-2475 r.skomro@usask.ca
Canada, Saskatchewan Sleep Disorders Center, Royal Univerisity Hospital, Saskatoon, Saskatchewan, S7N 0W0, Canada; Recruiting
Robert P Skomro, MD 306-966-2475 r.skomro@usask.ca
Study chairs or principal investigators
Robert P Skomro, MD, Principal Investigator, Univerisity of Saskatchewan
More Information
Study ID Numbers: REB# 04-91
Last Updated: August 29, 2005
Record first received: August 26, 2005
ClinicalTrials.gov Identifier: NCT00139022
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-08-30
Source: ClinicalTrials.gov
Cache Date: August 31, 2005