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
Protocol serial number	EAME07AFLEX01/02
Sponsor	Respironics International Inc. (France)
Funder	Respironics International, Inc. (France)

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

Primary study design	Interventional
Study design	Randomised, controlled, double-blind, cross-over study
Secondary study design	Randomised controlled trial
Study type	Participant 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(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.
Key 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
Completion date	30/09/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes