Condition category
Nervous System Diseases
Date applied
15/09/2008
Date assigned
09/10/2008
Last edited
09/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Steven Coughlin

ORCID ID

Contact details

20
rue Jacques Daguerre
Rueil Malmaison
Paris
92565
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EAMECFLEX2005

Study information

Scientific title

Acronym

C-Flex Web

Study hypothesis

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

Grenoble Ethics Committee granted approval on the 11th May 2005.

Study design

Randomised, single blind, controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 outcome measures

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.

Overall trial start date

15/06/2005

Overall trial end date

30/11/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Pregnant
2. Medically unstable
3. Predominantly central sleep apnoea

Recruitment start date

15/06/2005

Recruitment end date

30/11/2006

Locations

Countries of recruitment

France

Trial participating centre

20, rue Jacques Daguerre
Paris
92565
France

Sponsor information

Organisation

Respironics International, Inc. (France)

Sponsor details

20
rue Jacques Daguerre
Rueil Malmaison
Paris
92565
France

Sponsor type

Industry

Website

http://www.respironics.com/

Funders

Funder type

Industry

Funder name

Respironics International, Inc. (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

French Committee of Respiratory Diseases (Comité National contre les Maladies Respiratoires CNMR]) (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes