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Metabolic and Neurobiological changes after Continuous Positive Airway Pressure treatment for Obstructive Sleep Apnea

Metabolic and Neurobiological changes after Continuous Positive Airway Pressure (CPAP) treatment for Obstructive Sleep Apnea (OSA)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000301369
Acronym
MANPAP
Enrollment
60
Registered
2008-06-17
Start date
2008-06-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

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

Sydney South West Area Health Service
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 26, 2026