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Double blind parallel trial of Continuous Positive Airway Pressure versus CFLEX-a form of CPAP with exhalation pressure reduction: Effects on objective compliance, reaction time and objective alertness in patients with obstructive sleep apnoea

Double blind parallel trial of Continuous Positive Airway Pressure versus CFLEX-a form of CPAP with exhalation pressure reduction: Effects on objective compliance, reaction time and objective alertness in patients with obstructive sleep apnoea

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000359437
Enrollment
76
Registered
2007-07-04
Start date
2007-03-01
Completion date
2008-09-15
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

The aim of the study is to determine whether CFLEX, a type of CPAP treatment with exhalation pressure reduction, is used more by patients with obstructive sleep apnoea than standard CPAP. The hypothesis of the study is that CFLEX will be used on average more than CPAP over a 3 month period in patients with obstructive sleep apnoea.

Interventions

Continuous positive airway pressure (CPAP- control ) versus C-FLEX -a form of CPAP with exhalation pressure reduction (intervention). The subjects will use the treatment over a 3 month period each time they sleep.

Sponsors

Research and Enterprise, Otago University
Lead SponsorUniversity

Study design

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

Eligibility

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

Inclusion criteria

Adults (males and females) with polysomnographically confirmed obstructive sleep apnoea with an apnoea hypopnoea index of > 30 or >20 plus severe daytime sleepiness. Written and oral english language comprehension.

Exclusion criteria

Presence of another sleep disorderSignificant co-morbidityUpper airway surgery since diagnostic study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026