Pressure reduction during exhalation in sleep apnoea patients treated by continuous positive airway pressure (CPAP)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN08065291

Enrollment

200

Registered

2008-10-09

Start date

2005-06-15

Completion date

Unknown

Last updated

2021-01-11

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

Conditions

Obstructive sleep apnoea Nervous System Diseases Sleep disorders

Interventions

Experimental: C-Flex™ Control: CPAP The initial intervention will last for three months, after which patients on CPAP will be moved to C-Flex™ for a further 3 months.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed sleep apnoea patients 2. Over 18 years of age, either sex 3. Referred for CPAP treatment by their consulting physician

Exclusion criteria

Exclusion criteria: 1. Pregnant 2. Medically unstable 3. Predominantly central sleep apnoea

Design outcomes

Primary

Measure	Time frame
Compliance, measured at baseline and after 3 and 6 months. Compliance was monitored by the machine and reported via a Smartcard and reader using the Encore pro system.	—

Secondary

Measure	Time frame
1. Daytime sleepiness, assessed using the Epworth Sleepiness Scale 2. Quality of life, assessed using a generic questionnaire (36-item short form health survey [SF-36]) and a questionnaire specific to obstructive sleep apnoea syndrome (Grenoble Sleep Apnoea Quality of Life [GrenobleSAQOL]) Measured at baseline and after 3 and 6 months.	—

Countries

France

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026