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Variable-pressure versus fixed-pressure continuous positive airway pressure (CPAP) treatment for patients with obstructive sleep apnoea/hypopnoea syndrome (OSAHS)

Randomised controlled trial of variable-pressure versus fixed-pressure continuous positive airway pressure (CPAP) treatment for patients with obstructive sleep apnoea/hypopnoea syndrome (OSAHS)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN43085025
Enrollment
200
Registered
2009-05-11
Start date
2005-03-14
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Obstructive sleep apnoea/hypopnoea syndrome (OSAHS) Nervous System Diseases Sleep disorders

Interventions

This is a randomised double-blind cross-over trial with 6 weeks of fixed-pressure continuous positive airways pressure (CPAP) and 6 weeks of variable-pressure CPAP. The first two weeks of each treatme

Sponsors

Lothian NHS Board (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Both males and females, between 18 and 70 years of age 2. CPAP naïve patients 3. Epworth Sleepiness Scale (ESS) >10 OR history of troublesome sleepiness when driving 4. AHI >15 on polysomnography or AHI/respiratory disturbance index (RDI) >25 on limited sleep study

Exclusion criteria

Exclusion criteria: 1. Severe neurological deficit sufficient to compromise CPAP usability or understanding 2. Significant co-morbidity (severe or unstable respiratory, neurological, metabolic or cardiac disease) 3. Co-existing sleep disorder such as narcolepsy, periodic limb movement syndrome 4. Contra-indications to CPAP use including recent pneumothorax

Design outcomes

Secondary

MeasureTime frame
1. Patient-orientated effectiveness of treatment (sleepiness, symptoms, side-effects) 2. Physiologically-orientated effectiveness of CPAP (AHI, CPAP pressure, CPAP use)

Primary

MeasureTime frame
Patient preference, recorded once at trial end and assessed using a chi-square test.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026