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Randomised trial of compliance with flexible (C-Flex) and standard continuous positive airway pressure for severe obstructive sleep apnea

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Abstract

Introduction

Obstructive sleep apnea (OSA) is often treated with continuous positive airway pressure (CPAP) but the effectiveness of treatment is probably limited by poor compliance. CPAP manufacturers are thus attempting to devise more comfortable PAP devices in an effort to improve compliance. An example of such a novel device is Flexible expiratory-modulated PAP (C-Flex mode Respironics REMstar Pro, Murraysville, PA, USA).

Materials and methods

We aimed to compare compliance between C-Flex and standard CPAP in patients with severe OSA in a randomised controlled trial. Nineteen patients with severe OSA (mean ± SD Apnea Hypopnea Index = 78 ± 33/h, Epworth 14 ± 4, PAP 8–17 cm H2O, BMI = 39 ± 10 kg/m2) and aged 20–63 years were randomly assigned to 4 weeks of either C-Flex (setting II, n = 9) or CPAP (n = 10).

Results

Patients treated with C-Flex exhibited a trend toward higher compliance with their PAP devices compared to patients treated with standard CPAP (4.7 ± 2.9 vs. 3.0 ± 2.1 h/night, p = 0.15, effect size = 0.68). Paradoxically, improvements in subjective sleepiness (Epworth Sleepiness Scale) were greater in those who received CPAP than C-Flex (8.1 + 4.9 vs. 2.1 + 4.0 points, p = 0.014, effect size = 1.46). Improvements in objective wakefulness (Modified Maintenance of Wakefulness Test) and simple reaction times (Psychomotor Vigilance Task) were not significantly different between treatments. This randomised trial provides some evidence that C-Flex might increase initial treatment compliance, compared to CPAP, in patients with severe OSA. However, this trend toward greater compliance was not associated with better short-term treatment outcomes for patients. These findings need to be confirmed in a larger, longer-term trial.

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Authors and Affiliations

  1. Sleep/Wake Research Centre, Massey University, Wellington, New Zealand

    Nathaniel S. Marshall

  2. Department of Medicine, WellSleep, University of Otago at Wellington, Wellington, New Zealand

    Nathaniel S. Marshall, Alister M. Neill & Angela J. Campbell

  3. Sleep and Circadian Research Group, Woolcock Institute of Medical Research, P.O. Box M77, Missenden Road, Camperdown, New South Wales, 2050, Australia

    Nathaniel S. Marshall

Authors
  1. Nathaniel S. Marshall
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  2. Alister M. Neill
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  3. Angela J. Campbell
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Corresponding author

Correspondence to Nathaniel S. Marshall.

Additional information

Stipend from Massey University (to NSM).

None of the authors have had any financial relationships with Respironics Inc., who are the manufacturers of the device tested. Respironics International Inc., through their New Zealand suppliers Care Medical, provided six C-Flex machines for the purposes of this trial.

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Marshall, N.S., Neill, A.M. & Campbell, A.J. Randomised trial of compliance with flexible (C-Flex) and standard continuous positive airway pressure for severe obstructive sleep apnea. Sleep Breath 12, 393–396 (2008). https://doi.org/10.1007/s11325-008-0189-3

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  • DOI: https://doi.org/10.1007/s11325-008-0189-3

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