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

ISRCTN	ISRCTN08065291
DOI	https://doi.org/10.1186/ISRCTN08065291
Protocol serial number	EAMECFLEX2005
Sponsor	Respironics International, Inc. (France)
Funders	Respironics International, Inc. (France), French Committee of Respiratory Diseases (Comité National contre les Maladies Respiratoires CNMR]) (France)

Submission date: 15/09/2008
Registration date: 09/10/2008
Last edited: 30/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Steven Coughlin
Scientific

20, rue Jacques Daguerre
Rueil Malmaison
Paris
92565
France

Study information

Primary study design	Interventional
Study design	Randomised, single blind, controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Pressure reduction during exhalation in sleep apnoea patients treated by continuous positive airway pressure (CPAP)
Study acronym	C-Flex Web
Study objectives	This French, multicentre, randomised controlled trial tested the hypothesis that pressure reduction during exhalation (C-Flex™) would improve continuous positive airway pressure (CPAP) compliance, comfort and quality of life.
Ethics approval(s)	Grenoble Ethics Committee granted approval on the 11th May 2005.
Health condition(s) or problem(s) studied	Obstructive sleep apnoea
Intervention	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. Those on C-Flex™ during the first 3 months will remain on C-Flex™ for the second 3 months. Total duration will therefore be six months for all patients.
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/11/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	200
Total final enrolment	218
Key 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
Key exclusion criteria	1. Pregnant 2. Medically unstable 3. Predominantly central sleep apnoea
Date of first enrolment	15/06/2005
Date of final enrolment	30/11/2006

Locations

Countries of recruitment

France

Study participating centre

20, rue Jacques Daguerre

Paris
92565
France

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2009	30/12/2020	Yes	No

Editorial Notes

30/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.