Evaluation of fixed continuous positive airway pressure (CPAP) with C-Flex+ against fixed CPAP

Evaluation of fixed continuous positive airway pressure (CPAP) with C-Flex+ against fixed CPAP in patients with obstructive sleep apnoea

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN04363711

Enrollment

Registered

2011-01-13

Start date

2011-01-10

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 Nervous System Diseases Sleep disorders

Interventions

Following the standard education and acclimatisation program of the centre, in which subjects will undergo a daytime CPAP session at a constant pressure of 5 cmH2O using several different interface mo

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 15.0/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 sleep disorders, including but not limited to; insomnia, periodic leg movements (PLM)/restless legs syndrome (RLS) 5. Treated insomnia 6. Intake of central relevant drugs, sedatives, or other drugs which impair sleep 7. Previous exposure to positive airways pressure therapy 8. Acute dermatitis or other skin lesions or trauma interfering with the application of a mask 9. Unwilling to participate in the study 10. Participation in another clinical study in the past 4 weeks 11. Shift worker

Design outcomes

Primary

Measure	Time frame
In order to test the primary hypothesis the following PSG variables will be assessed: 1. AHI (total, REM and NREM) - total, obstructive, central, mixed and hypopnoea Comparisons will be made using the above data. These continuous variables will be summarised using means (and standard deviations) or median (interquartile range), depending on the distribution. The within-patient differences between the modes will be presented for each of these variables using mean differences and 95% confidence intervals. The 95% confidence bounds (one sided) will be scrutinised to determine whether or not non-inferiority of the fixed CPAP with C-Flex+ can be declared.	—

Measure

Time frame

In order to test the primary hypothesis the following PSG variables will be assessed: 1. AHI (total, REM and NREM) - total, obstructive, central, mixed and hypopnoea Comparisons will be made using the above data. These continuous variables will be summarised using means (and standard deviations) or median (interquartile range), depending on the distribution. The within-patient differences between the modes will be presented for each of these variables using mean differences and 95% confidence intervals. The 95% confidence bounds (one sided) will be scrutinised to determine whether or not non-inferiority of the fixed CPAP with C-Flex+ can be declared.

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Secondary

Measure	Time frame
In order to test the secondary hypotheses the following variables will be assessed: 1. SpO2 - Nocturnal oxygenation 1.1. Total time spent less than 90% 1.2. Lowest SpO2 during the night 1.3. Average SpO2 during the night 2. TST - Total sleep time 3. SE% Sleep efficiency 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/% R sleep 4.3. Min/% Wake After Sleep Onset (WASO) 4.4. Arousals: 4.4.1. # of arousals/awakenings (all cause) 4.4.2. Arousals due to PLMS 4.4.3. Arousal Index (AI) 4.4.4. Arousals due to Respiratory Disturbance (RDI) Comparisons will be made using the above data. These continuous variables will be summarised using means (and standard deviations) or median (interquartile range), depending on the distribution. The within-patient differences between the modes will be presented for each of these variables using mean differences and 95% confidence intervals. The 95% confidence bounds (one sided) will be scrutinised to determine whether or not non-inferiority of fixed CPAP with C-Flex+ can be declared. 5. Average Pressure Outputs will be summarised using means (and standard deviations) or median (interquartile range), depending on the distribution. The pairwise within-patient differences between the modes will be presented as mean differences and 95% confidence intervals, and the single sample t-test will be used to assess whether the differences between the modes are statistically significant. 6. Comfort - The 10cm comfort visual analogue scale will be summarised for each of the modes from data collected on nights 1 and 2 of the study using means (and standard deviations) or median (interquartile range), depending on the distribution of the data. The pairwise within-patient differences between the modes will be presented as mean differences and 95% confidence intervals, and the single sample t-test will be used to assess whether the differences between the modes are statistically significant. 7.	—

Measure

Time frame

In order to test the secondary hypotheses the following variables will be assessed: 1. SpO2 - Nocturnal oxygenation 1.1. Total time spent less than 90% 1.2. Lowest SpO2 during the night 1.3. Average SpO2 during the night 2. TST - Total sleep time 3. SE% Sleep efficiency 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/% R sleep 4.3. Min/% Wake After Sleep Onset (WASO) 4.4. Arousals: 4.4.1. # of arousals/awakenings (all cause) 4.4.2. Arousals due to PLMS 4.4.3. Arousal Index (AI) 4.4.4. Arousals due to Respiratory Disturbance (RDI) Comparisons will be made using the above data. These continuous variables will be summarised using means (and standard deviations) or median (interquartile range), depending on the distribution. The within-patient differences between the modes will be presented for each of these variables using mean differences and 95% confidence intervals. The 95% confidence bounds (one sided) will be scrutinised to determine whether or not non-inferiority of fixed CPAP with C-Flex+ can be declared. 5. Average Pressure Outputs will be summarised using means (and standard deviations) or median (interquartile range), depending on the distribution. The pairwise within-patient differences between the modes will be presented as mean differences and 95% confidence intervals, and the single sample t-test will be used to assess whether the differences between the modes are statistically significant. 6. Comfort - The 10cm comfort visual analogue scale will be summarised for each of the modes from data collected on nights 1 and 2 of the study using means (and standard deviations) or median (interquartile range), depending on the distribution of the data. The pairwise within-patient differences between the modes will be presented as mean differences and 95% confidence intervals, and the single sample t-test will be used to assess whether the differences between the modes are statistically significant. 7.

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Countries

Germany

Outcome results

None listed

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