The effect of Oral Appliance Therapy (OAT) for Obstructive Sleep Apnoea (OSA) on markers of cardiovascular risk
Not Applicable
- Conditions
- Obstructive Sleep ApnoeaCardiovascular DiseaseRespiratory - Sleep apnoeaCardiovascular - Coronary heart disease
- Registration Number
- ACTRN12620000014954
- Lead Sponsor
- orthern Sydney Local Health District
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 105
Inclusion Criteria
Obstructive Sleep Apnoea (with ODI(4%) > 15 events/hour)
Framingham risk score >15%
BMI < 35 kgm2
Exclusion Criteria
Previous use of OAT for OSA
Use of any OSA therapy in the prior 3 months
Contra-indications to OAT (as determined by dentist (e.g. periodontal disease, insufficient number of teeth to retain the device)
Need for immediate OSA therapy as assessed by a sleep physician (e.g. commercial drivers)
Women who are lactating or pregnant
Established cardio- or cerebro-vascular disease (e.g. stroke, coronary heart disease, heart failure, cardiomyopathy, congenital heart disease)
Central Sleep Apnoea (>10% central events)
Co-existing sleep disorder or lung disease (e.g. COPD)
Inability to provide informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method