Therapy-efficacy of automatic positive airways pressure therapy with A-Flex compared to standard automatic positive airways pressure therapy in obstructive sleep apnoea (OSA) patients

ISRCTN ISRCTN93709209
DOI https://doi.org/10.1186/ISRCTN93709209
Secondary identifying numbers EAME07AFLEX01/02
Submission date
18/04/2008
Registration date
15/05/2008
Last edited
15/05/2008
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 Ingo Fietze
Scientific

Charité-Universitätsmedizin Berlin
Campus Mitte
Schlafmedizinisches Zentrum
Zentrale Poliklinik, BT2591
Ebene 02, Zimmer 044
Luisenstr. 13
Berlin
10117
Germany

Study information

Study designRandomised, controlled, double-blind, cross-over study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymA-Flex Validation
Study objectivesA-Flex is as effective as automatic positive airways pressure (APAP) in reducing respiratory events and arousals in patients with obstructive sleep apnoea (OSA).
Ethics approval(s)Ethics approval received from:
1. France: Ethics of Lille on the 11th February 2008
2. Germany: Charite Ethikkommission, Mitte Campus on the 30th July 2008
Health condition(s) or problem(s) studiedObstructive sleep apnoea
InterventionA-Flex: automatic positive airways pressure device featuring pressure relief technology
APAP: standard automatic positive airways pressure device

The duration of treatment and follow up during the fixed follow-up period will be three months in both arms.
Intervention typeOther
Primary outcome measureA-Flex is as effective as APAP in reducing respiratory events and arousals in patients with OSA, measured with the Apnoea-Hypopnea Index at baseline.
Secondary outcome measures1. A-Flex is more comfortable than APAP, measured using the Visual Analogue Scale [VAS] at baseline
2. Compliance (internal clock within the device) is higher on A-Flex compared to APAP, measured at one and three months
3. Subjective daytime sleepiness is improved on A-Flex compared to APAP, measured using the Epworth Sleepiness Scale at baseline, one and three months
4. Quality of life is improved on A-Flex compared to APAP, measured using the Functional Outcomes of Sleep Questionnaire at baseline, one and three months
Overall study start date01/08/2007
Completion date30/09/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40
Key inclusion criteria1. Apnoea-Hypopnoea Index (AHI) greater than 15/h confirmed by full polysomnograph (PSG)
2. Aged greater than or equal to 21 to 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
Key exclusion criteria1. Acute upper respiratory infection, encephalitis, sinusitis or middle ear infection
2. Drug abuse
3. Intake of central relevant drugs, sedatives, or other drugs which impair sleep
4. Alcohol abuse
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 continuous positive airways pressure (CPAP) or bi-level therapy
13. Patients experiencing acute dermatitis or other skin lesions or trauma interfering with the application of a mask
14. Participation in another clinical study in the past four weeks
Date of first enrolment01/08/2007
Date of final enrolment30/09/2008

Locations

Countries of recruitment

  • France
  • Germany

Study participating centre

Charité-Universitätsmedizin Berlin
Berlin
10117
Germany

Sponsor information

Respironics International Inc. (France)
Industry

20 Rue Hacques Daguerre
Rueil-Malmaison
Paris
92500
France

Website http://www.respironics.com/
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan