None listed
Conditions
Brief summary
This study is designed to investigate nasal Continuous Positive Airway Pressure (CPAP) therapy’s efficacy to improve important intermediate markers of cardio-metabolic health (visceral fat, insulin sensitivity, central blood pressure, arterial stiffness).
Interventions
Blinded Continuous Positive Airway Pressure for 12 weeks followed by open-label CPAP treatment for 12 weeks. The subjects will undergo a 3 night home-titration using an auto-titrating machine. The machine will then be set to the 90th percentile on a fixed pressure for the remainder of the study. We are using an identical Sham machine. A trained CPAP technologist who had been involved in other similar sham-controlled trials is responsible for the allocation of the CPAP machines for this and all other studies. Only this person has access to the sham machines, which she stores separately from the effective CPAP machines. This person will have no direct contact with the subjects. This is a 24 week study. For the first 12 weeks of the study, Week 0 to Week 12, the subject is randomised to use either therapeutic CPAP or sham CPAP every night for the entire 12 weeks. This first 12 weeks is blinded. From Week 12 to Week 24 every subject is changed to receive open-label therapeutic CPAP every night for the entire 12 weeks. They will return the blinded machine they used from Week 0 to Week 12 and will receive a new therapeutic machine.
Sponsors
Study design
Eligibility
Inclusion criteria
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.
Exclusion criteria
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