Condition category
Nervous System Diseases
Date applied
29/10/2008
Date assigned
11/12/2008
Last edited
20/11/2012
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 Ingo Fietze

ORCID ID

Contact details

Center of Sleep Medicine
Department of Internal Medicine
Charité-Universitätsmedizin Berlin
CCM
Luisenstr. 13
Berlin
10117
Germany
ingo.fietze@charite.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EAME05AUTOBILEVEL01

Study information

Scientific title

Acronym

AUTOBILEVEL

Study hypothesis

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

Ethikkommission of Charite Campus-Mitte gave approval on the 1st March 2006 (ref: EA1/044/08)

Study design

Controlled, double-blind randomised study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

05/06/2006

Overall trial end date

09/06/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

32

Participant 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

Recruitment start date

05/06/2006

Recruitment end date

09/06/2007

Locations

Countries of recruitment

Germany

Trial participating centre

Center of Sleep Medicine
Berlin
10117
Germany

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21874370

Publication citations

  1. Results

    Blau A, Minx M, Peter JG, Glos M, Penzel T, Baumann G, Fietze I, Auto bi-level pressure relief-PAP is as effective as CPAP in OSA patients--a pilot study., Sleep Breath, 2012, 16, 3, 773-779, doi: 10.1007/s11325-011-0574-1.

Additional files

Editorial Notes