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
Scientific
Charité-Universitätsmedizin Berlin
Campus Mitte
Schlafmedizinisches Zentrum
Zentrale Poliklinik, BT2591
Ebene 02, Zimmer 044
Luisenstr. 13
Berlin
10117
Germany
Study information
Study design | Randomised, controlled, double-blind, cross-over 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 | A-Flex Validation |
Study objectives | A-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) studied | Obstructive sleep apnoea |
Intervention | A-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 type | Other |
Primary outcome measure | A-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 measures | 1. 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 date | 01/08/2007 |
Completion date | 30/09/2008 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Sex | Both |
Target number of participants | 40 |
Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 01/08/2007 |
Date of final enrolment | 30/09/2008 |
Locations
Countries of recruitment
- France
- Germany
Study participating centre
Charité-Universitätsmedizin Berlin
Berlin
10117
Germany
10117
Germany
Sponsor information
Respironics International Inc. (France)
Industry
Industry
20 Rue Hacques Daguerre
Rueil-Malmaison
Paris
92500
France
Website | http://www.respironics.com/ |
---|---|
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 |