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 |
| Secondary identifying numbers | EAME06AUTOBILEVEL01 |
- 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
Scientific
Laboratoire du Sommeil
Clinique De La Louviere
69 Rue de la Louviere
59800
Lille
59800
France
| t.gentina@wanadoo.fr |
Study information
| Study design | Observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Other |
| Study setting(s) | Other |
| Study type | Treatment |
| 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 | 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 study start date | 21/08/2006 |
| Completion date | 26/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
59800
France
Sponsor information
Respironics International Inc. (France)
Industry
Industry
20 Rue-Jacques Daguerre
Rueil-Malmaison
Paris
92500
France
| steven.coughlin@respironics.com | |
| Website | http://www.respironics.com |
"ROR" |
https://ror.org/05jz46060 |
Funders
Funder type
Industry
Respironics International Inc. (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
