BiPAP Auto with BiFlex® as a rescue therapy for optimally treated obstructive sleep apnoea patients who demonstrate poor compliance to continuous positive airway pressure therapy

ISRCTN	ISRCTN88398555
DOI	https://doi.org/10.1186/ISRCTN88398555
Protocol serial number	EAME06AUTOBILEVEL01
Sponsor	Respironics International Inc. (France)
Funder	Respironics International Inc. (France)

Submission date: 05/11/2008
Registration date: 11/12/2008
Last edited: 14/11/2013

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Thibault Gentina
Scientific

Laboratoire du Sommeil
Clinique De La Louviere
69 Rue de la Louviere
59800
Lille
59800
France

Email	t.gentina@wanadoo.fr

Study information

Primary study design	Observational
Study design	Observational study
Secondary study design	Other
Scientific title
Study acronym	AUTOBILEVEL
Study objectives	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(s)	Ethics Committee for Protection of Human Subjects in Biomedical Research (CCPPRB), Lille, 02/05/2006, ref: CP 06/57
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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.
Completion date	26/02/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	30
Key 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
Key exclusion criteria	1. Wrong mask choice 2. Wrong mask size 3. Nasal congestion 4. Other symptoms requiring humidification
Date of first enrolment	21/08/2006
Date of final enrolment	26/02/2008

Locations

Countries of recruitment

France

Study participating centre

Laboratoire du Sommeil

Lille
59800
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