Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EAME07AFLEX01/02
Study information
Scientific title
Acronym
A-Flex Validation
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
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
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/08/2007
Overall trial end date
30/09/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/08/2007
Recruitment end date
30/09/2008
Locations
Countries of recruitment
France, Germany
Trial participating centre
Charité-Universitätsmedizin Berlin
Berlin
10117
Germany
Sponsor information
Organisation
Respironics International Inc. (France)
Sponsor details
20 Rue Hacques Daguerre
Rueil-Malmaison
Paris
92500
France
Sponsor type
Industry
Website
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