ACTRN12608000514303
Completed
Not Applicable
A randomised controlled trial to evaluate a simplified management strategy for moderate-to-severe obstructive sleep apnea comparing improvements in daytime sleepiness in patients managed in primary care (general practitioner assisted by a sleep specialist nurse) versus usual care in a sleep specialist centre
ational Health and Medical Research Council0 sites250 target enrollmentOctober 2, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstructive sleep apnea
- Sponsor
- ational Health and Medical Research Council
- Enrollment
- 250
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Moderate\-to\-severe obstructive sleep apnea (OSA) \- positive on OSA50 screening questionnaire; Epworth sleepiness scale (ESS)\>\=8 or poorly\-controlled hypertension despite 2 or more antihypertensive agents; ApneaLink 3% oxygen desturation index (ODI)\>\=16
Exclusion Criteria
- •Body mass index (BMI)\>50
- •Neuromuscular disease
- •Significant psychiatric disease which would affect patient's ability to comply with study protocol
- •Cognitive disability that would prevent self management of CPAP
- •Recent hospitalisation for myocardial infarction (MI), unstable angina, cardiac failure, cerebrovascular accident (CVA) or transient ischemic attack (TIA) in past 3 months, and/or New York Heart Association (NYHA) Class 3 or 4
- •Moderate\-to\-severe respiratory disease (documented hypoxia or awake oxygen saturation \<92%)
Outcomes
Primary Outcomes
Not specified
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