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
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