None listed
Conditions
Brief summary
This study will compare health outcomes and costs for patients diagnosed with moderate to severe obstructive sleep apnea managed by either their general practitioner assisted by a sleep-trained nurse in the community or by a sleep physician in a hospital outpatient setting.
Interventions
General practice-based management for a total of 6 months. Patients will have an auto-continuous positive airway pressure (CPAP) titration study at home over 3 nights to determine their CPAP treatment pressure. CPAP therapy will be worn by patients at night for the 6 month duration of the study and followed up by a sleep nurse based in the community at 1, 3 and 6 months and their general practitioner at 3 and 6 months. Each follow-up visit with the nurse will be of 30 minutes duration, and 15-20
General practice-based management for a total of 6 months. Patients will have an auto-continuous positive airway pressure (CPAP) titration study at home over 3 nights to determine their CPAP treatment pressure. CPAP therapy will be worn by patients at night for the 6 month duration of the study and followed up by a sleep nurse based in the community at 1, 3 and 6 months and their general practitioner at 3 and 6 months. Each follow-up visit with the nurse will be of 30 minutes duration, and 15-20 minutes for general practitioner review.
Sponsors
National Health and Medical Research Council
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
25 Years to 70 Years
Healthy volunteers
No
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%)
Outcome results
None listed