System One™ study: evaluation of the System One™ REMstar® Auto A-Flex for the treatment of obstructive sleep apnoea (OSA)

ISRCTN	ISRCTN19824122
DOI	https://doi.org/10.1186/ISRCTN19824122
Secondary identifying numbers	EAME09PRSTS01

Submission date: 24/11/2010
Registration date: 14/01/2011
Last edited: 14/01/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

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 Frédéric Gagnadoux
Scientific

Départment de Pneumologie
CHU, 4 rue Larrey
Angers
49033
France

Study information

Study design	Multicentre randomised controlled crossover group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
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
Study acronym	System One™ study
Study objectives	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(s)	Currently being applied for in Denmark, Netherlands and France
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	04/04/2011
Completion date	19/10/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	60
Key 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
Key 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
Date of first enrolment	04/04/2011
Date of final enrolment	19/10/2012

Locations

Countries of recruitment

Denmark
France
Netherlands

Study participating centre

Départment de Pneumologie

Angers
49033
France

Sponsor information

Respironics International Inc (France)
Industry

c/o Dr S Coughlin / Jane Korbey
Philips France Comptabilité Fournisseurs
33 rue de Verdun
Paris
92156
France

Phone	+44(0)776 6025526
Email	jane.korbey@philips.com
Website	http://www.respironics.com
"ROR"	https://ror.org/05jz46060

Funders

Funder type

Industry

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan