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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN19824122

Enrollment

Registered

2011-01-14

Start date

2011-04-04

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive sleep apnoea (OSA) Respiratory Sleep disorders

Interventions

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 S

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Apnoea-hypopnoea index (AHI)	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Denmark, France, Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026