Condition category
Nervous System Diseases
Date applied
05/11/2008
Date assigned
11/12/2008
Last edited
14/11/2013
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

Dr Thibault Gentina

ORCID ID

Contact details

Laboratoire du Sommeil
Clinique De La Louviere
69 Rue de la Louviere
59800
Lille
59800
France
t.gentina@wanadoo.fr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EAME06AUTOBILEVEL01

Study information

Scientific title

Acronym

AUTOBILEVEL

Study hypothesis

BiPAP Auto with Bi-Flex® therapy will improve compliance, subjective sleepiness and quality of life in obstructive sleep apnoea patients who demonstrate poor compliance to standard fixed pressure therapy.

Ethics approval

Ethics Committee for Protection of Human Subjects in Biomedical Research (CCPPRB), Lille, 02/05/2006, ref: CP 06/57

Study design

Observational study

Primary study design

Observational

Secondary study design

Other

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Obstructive sleep apnoea

Intervention

After a full polysomnography (PSG) patients will be given a BiPAP Auto with Bi-Flex® device. Patients will be followed up at 15 days and 10 weeks.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To determine whether rescuing optimally treated OSA patients who demonstrate poor compliance to PAP therapy by transitioning them onto BiPAP Auto with Bi-Flex improves compliance, subjective sleepiness and quality of life.

1. Compliance will be measured at 15 days and 10 weeks by retrieving device data
2. Subjective compliance and quality of life will be measured by Epworth Sleepiness Questionnaire and Functional Outcomes of Sleep Therapy questionnaire at baseline, 15 days and 10 weeks

Secondary outcome measures

1. Determination of comfort between BiPAP Auto with Bi-Flex® and previous device used. Measured by Device Comfort scale at baseline, 15 days and 10 weeks.
2. Identify barriers to successful transition onto BiPAP Auto with Bi-Flex®. Patients' previous machine type and mask will be noted and effect on transition assessed.
3. To determine the machine types used by patients who demonstrate poor compliance to fixed PAP therapy and their treatment efficacy during sleep. Previous machine type will be noted at baseline and treatment efficiency during baseline PSG.

Tertiary objective:
4. To investigate the level of agreement between Apnoea-Hypopnea Index (AHI) measured at Visit 1 (15 days) by PSG and an autotitrating PAP device in a subgroup of patients. Carried out at Visit 1 by PSG.

Overall trial start date

21/08/2006

Overall trial end date

26/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female patients 18+
2. Compliance to positive airway pressure (PAP) below the minimally acceptable level of 4 hours use on >=70% of nights over the past 4 weeks
3. Ability to provide written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Wrong mask choice
2. Wrong mask size
3. Nasal congestion
4. Other symptoms requiring humidification

Recruitment start date

21/08/2006

Recruitment end date

26/02/2008

Locations

Countries of recruitment

France

Trial participating centre

Laboratoire du Sommeil
Lille
59800
France

Sponsor information

Organisation

Respironics International Inc. (France)

Sponsor details

20 Rue-Jacques Daguerre
Rueil-Malmaison
Paris
92500
France
steven.coughlin@respironics.com

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

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