Condition category
Nervous System Diseases
Date applied
18/04/2008
Date assigned
15/05/2008
Last edited
15/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ingo Fietze

ORCID ID

Contact details

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

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

http://www.respironics.com/

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

Publication citations

Additional files

Editorial Notes