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25 July 2008
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| [ Print-friendly version ] |
| 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 |
| ClinicalTrials.gov identifier | |
| Public title | 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 |
| Scientific title | |
| Acronym | A-Flex Validation |
| Serial number at source | EAME07AFLEX01/02 |
| Study hypothesis | 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 |
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 |
| Study design | Randomised, controlled, double-blind, cross-over study |
| Countries of recruitment | France, Germany |
| Disease/condition/study domain | Obstructive sleep apnoea |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/08/2007 |
| Anticipated end date | 30/09/2008 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 40 |
| Interventions |
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. |
| Primary outcome measure(s) | 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 measure(s) |
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 |
| Sources of funding | Respironics International, Inc. (France) |
| Trial website | |
| Publications | |
| Contact name | Dr Ingo Fietze |
| Address |
Charité-Universitätsmedizin Berlin
Campus Mitte Schlafmedizinisches Zentrum Zentrale Poliklinik, BT2591 Ebene 02, Zimmer 044 Luisenstr. 13 |
| City/town | Berlin |
| Zip/Postcode | 10117 |
| Country | Germany |
| Sponsor | Respironics International Inc. (France) |
| Address |
20 Rue Hacques Daguerre
Rueil-Malmaison |
| City/town | Paris |
| Zip/Postcode | 92500 |
| Country | France |
| Sponsor website: | http://www.respironics.com/ |
| Date applied | 18/04/2008 |
| Last edited | 15/05/2008 |
| Date ISRCTN assigned | 15/05/2008 |
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