Therapy efficacy, compliance and long-term outcome of Auto-bilevel therapy compared to continuous positive airway pressure (CPAP) therapy in obstructive sleep apnoea (OSA) patients
| ISRCTN | ISRCTN53816305 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53816305 |
| Secondary identifying numbers | EAME05AUTOBILEVEL01 |
- Submission date
- 29/10/2008
- Registration date
- 11/12/2008
- Last edited
- 20/11/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ingo Fietze
Scientific
Scientific
Center of Sleep Medicine
Department of Internal Medicine
Charité-Universitätsmedizin Berlin, CCM
Luisenstr. 13
Berlin
10117
Germany
| ingo.fietze@charite.de |
Study information
| Study design | Controlled, double-blind randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | |
| Study acronym | AUTOBILEVEL |
| Study objectives | We hypothesised that auto-bilevel therapy would be equivalant to fixed continuous positive airway pressure (CPAP) therapy on parameters of objective and subjective compliance and therapeutic effectiveness in patients with moderate to severe obstructive sleep apnoea. |
| Ethics approval(s) | Ethikkommission of Charite Campus-Mitte gave approval on the 1st March 2006 (ref: EA1/044/08) |
| Health condition(s) or problem(s) studied | Obstructive sleep apnoea |
| Intervention | After a CPAP titration night patients will be randomised to three months of either BiPAP auto with Biflex or fixed level CPAP. Patients will be followed up at 1, 4, 8 and 12 weeks. |
| Intervention type | Other |
| Primary outcome measure | Treatment and therapeutic efficacy will be measured by polysomnography (PSG) at diagnosis, titration and 12 weeks (end of study). |
| Secondary outcome measures | 1. Objective compliance measured by device memory download at one week and the end of the study 2. Subjective compliance and parameters of wellbeing measured at baseline, 4, 8, 12 weeks 3. Epworth Sleepiness Scale measured at baseline (after diagnostic PSG and after titration PSG), 4, 8 and 12 weeks 4. Pittsburgh Sleep Quality Index measured at baseline (after diagnostic PSG only), 4, 8 and 12 weeks 5. Functional Outcomes of Sleep Questionnaire measured at baseline (after diagnostic PSG only), 4, 8 and 12 weeks 6. Calgary Sleep Apnoea Quality of Life Index measured at baseline (after diagnostic PSG only), 4, 8 and 12 weeks 7. 12-item Short Form (SF-12) measured at baseline (after diagnostic PSG only), 4, 8 and 12 weeks 8. Visual Analogue Scale measured in the morning and evening at baseline (after diagnostic PSG and after titration PSG), 4, 8 and 12 weeks 9. Treatment Satisfaction Visual Analogue Scale measured at baseline (after titration PSG only), 4, 8 and 12 weeks 10. Treatment Comfort Visual Analogue Scale measured at baseline (after titration PSG only), 4, 8 and 12 weeks 11. Mask/Interface Comfort Visual Analogue Scale measured at baseline (after titration PSG only), 4, 8 and 12 weeks |
| Overall study start date | 05/06/2006 |
| Completion date | 09/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 32 |
| Key inclusion criteria | 1. Apnoea/Hypopnoea Index (AHI) greater than 15/h 2. Aged greater than or equal to 21 years and less than or equal to 65 years, either sex 3. Body mass index (BMI) less than 40 kg/m^2 4. Able to follow the study protocol 5. Successful CPAP titration |
| Key exclusion criteria | 1. Drug abuse 2. Intake of central relevant drugs, sedatives, or other drugs with impairment of sleep 3. Alcohol abuse; consume more than 30 g/d 4. Participation in other clinical-pharmacological studies up to 4 weeks prior of study begin 5. Psychiatric or neurological diseases resulting in impairment of sleep, therapy or compliance 6. Thyroidal dysfunction 7. Chronic pain syndromes 8. Acute cardiac, pulmonary, and other internal diseases 9. Chronic cardiac, pulmonary and other internal diseases resulting in impairment of sleep 10. Central sleep-related breathing disorders or other disorders resulting in hypoventilation 11. Periodic leg movements (PLM)/restless legs syndrome (RLS) 12. Previous exposure to either CPAP or bilevel therapy |
| Date of first enrolment | 05/06/2006 |
| Date of final enrolment | 09/06/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
Center of Sleep Medicine
Berlin
10117
Germany
10117
Germany
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2012 | Yes | No |
