Metabolic and Neurobiological changes after Continuous Positive Airway Pressure treatment for Obstructive Sleep Apnea
- Conditions
- Obstructive Sleep ApneaRespiratory - Sleep apnoea
- Registration Number
- ACTRN12608000301369
- Lead Sponsor
- Sydney South West Area Health Service
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 60
1. Males aged 18 years or above.
2. Moderate to severe obstructive sleep apnea with respiratory disturbance Index (RDI) =20/hr and inclusive of =3% desaturation (RDI >=20 and ODI >=15)
3. Written informed consent
4. Good general health as defined as men who are community dwelling, with no significant uncontrolled medical problems who are independent in activities of daily living.
5. Medical history and physical examination indicating no clinical evidence for significant and uncontrolled cardiovascular (ischemic, hypertension), diabetes, renal, liver, prostate or any other disease.
1. Severe OSA (minimum oxygen saturation < 65% or RDI > 80) requiring immediate treatment due to severity or increased associated risk (eg Transport worker)
2. Psychiatric disorders or drug abuse unless well controlled
3. Chronic medical conditions likely to interfere with or influence study treatment or safety unless well controlled
4. Contradictions to CPAP therapy
5. Any other condition likely, in the judgment of the investigator, that makes the patient unable to complete safely, or otherwise unsuitable for the study
6. Shift workers
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Abdominal Visceral Fat<br>Single slice 3D Computerised Tomography (CT) scan of the abdomen. The single slice is taken in relation to a bony landmark (eg T12/L1 or L4/L5 in the axial plane) and hence is reproducible serially.[12 weeks after Randomisation]
- Secondary Outcome Measures
Name Time Method