Condition category
Respiratory
Date applied
24/11/2010
Date assigned
14/01/2011
Last edited
14/01/2011
Prospective/Retrospective
Prospectively 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 Frédéric Gagnadoux

ORCID ID

Contact details

Départment de Pneumologie
CHU
4 rue Larrey
Angers
49033
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EAME09PRSTS01

Study information

Scientific title

Evaluation of the System One™ REMstar® Auto A-Flex for the treatment of obstructive sleep apnoea (OSA): an international, randomised, controlled, crossover trial

Acronym

System One™ study

Study hypothesis

1. Automatic positive airway pressure (APAP) delivered throughout the night by the System One™ REMstar® Auto A-Flex, to subjects with obstructive sleep apnoea (OSA) is as effective as fixed continuous positive airway pressure (CPAP) delivered by the same device
2. The breathing event output (total and by epoch) from the System One™ REMstar® Auto A-Flex will result in a number of events (clear airway apnoea, obstructed airway apnoea, hypopnoea, apnoea hypopnoea index [AHI], respiratory effort related arousals and Cheyne Stokes Respiration) that is in agreement with those obtained from a full clinical polysomnography (PSG).

Ethics approval

Currently being applied for in Denmark, Netherlands and France

Study design

Multicentre randomised controlled crossover group trial

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 contact details below to request a patient information sheet

Condition

Obstructive sleep apnoea (OSA)

Intervention

Following the CPAP titration study, subjects will be randomly assigned to one night of APAP and one night of fixed CPAP delivered by the System One™ REMstar® Auto A-Flex on consecutive nights in the Sleep Laboratory by the PSG technician with full PSG monitoring. The therapeutic pressure from the CPAP titration study will be applied on the fixed CPAP night and the APAP system will be allowed to determine the PAP level on the auto night. These studies should be performed within 14 days of the CPAP determination study. Humidification will be standardised at the level from the CPAP determination study. The same interface will also be used on each occasion.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Apnoea-hypopnoea index (AHI)

Secondary outcome measures

1. Nocturnal oxygenation (SpO2)
1.1. Total time spent less than 90%
1.2. Lowest SpO2 during the night
1.3. Average SpO2 during the night
2. Total sleep time (TST)
3. Sleep efficiency (SE) %
4. Sleep architecture:
4.1. Min/% Non-REM sleep
4.1.1. Min/% N1
4.1.2. Min/% N2
4.1.3. Min/% N3
4.2. Min/% REM sleep
4.3. Min/% wake after sleep onset (WASO)
4.4. Arousals
4.4.1. No. of arousals/awakenings (all cause)
4.4.2. Arousals due to periodic limb movements in sleep (PLMS)
4.4.3. Arousal Index (AI)
4.4.5. Arousals due to respiratory disturbance (RDI)
5. Average pressure outputs
6. 90% pressure outputs

Overall trial start date

04/04/2011

Overall trial end date

19/10/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. AHI greater than 15 confirmed (greater than than 50% obstructive events) by full PSG within last 14 days
2. Age greater than or equal to 21 years of age
3. Able to provide consent
4. Able to follow the instructions given by the investigator regarding using their CPAP device and their participation in this study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Inability to tolerate CPAP during the daytime CPAP session
2. Failure of CPAP to adequately treat OSA during titration (AHI greater than or equal to 10.0 /h under the determined optimal pressure)
3. PAP therapy is otherwise medically contraindicated: acute upper respiratory infection, encephalitis, sinusitis or middle ear infection or surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
4. Untreated, non-OSA/CSA sleep disorders, including but not limited to; insomnia, periodic leg movements (PLM)/restless legs syndrome (RLS)
5. Intake of central relevant drugs, sedatives, or other drugs which impair sleep
6. Previous exposure to positive airways pressure therapy
7. Acute dermatitis or other skin lesions or trauma interfering with the application of a mask
8. Unwilling to participate in the study
9. Participation in another clinical study in the past 4 weeks
10. Shift worker
11. Other major medical disease/disorder that, at the discretion of the Primary Investigator (PI), renders the subject inappropriate for this study

Recruitment start date

04/04/2011

Recruitment end date

19/10/2012

Locations

Countries of recruitment

Denmark, France, Netherlands

Trial participating centre

Départment de Pneumologie
Angers
49033
France

Sponsor information

Organisation

Respironics International Inc (France)

Sponsor details

c/o Dr S Coughlin / Jane Korbey
Philips France Comptabilité Fournisseurs
33 rue de Verdun
Paris
92156
France
+44(0)776 6025526
jane.korbey@philips.com

Sponsor type

Industry

Website

http://www.respironics.com

Funders

Funder type

Industry

Funder name

Respironics International Inc (France) - an Activity of Philips, 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