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Validation of the System One RemStar Auto A-Flex for Obstructive Sleep Apnea Treatment and Detection of Residual Apnea-Hypopnea Index: A European Randomized Trial

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Abstract
Study Objectives: Autotitrating continuous positive airway pressure (CPAP) devices adjust pressure in response to changes in airflow and are an alternative to attended in-laboratory titration polysomnography (PSG) to determine optimal pressure levels. The aim of this study was to compare the performance of the System One RemStar Auto A-Flex (Philips Respironics, Murrysville, PA, USA) automatically adjusted positive airway pressure (APAP) mode to manually titrated, fixed pressure CPAP and to validate the device's breathing event detection capabilities against attended in-laboratory PSG. Methods: Sixty-one patients investigated in five centers for moderate to severe obstructive sleep apnea between May 2012 and June 2013 were invited to participate. Participants underwent two full-night attended polysomnograms in random order with manually titrated, fixed pressure CPAP versus APAP. Results: Fifty-three participants with a mean apnea-hypopnea index (AHI) of 45.9 +/- 23 completed two sleep studies and were included in the analysis. There were significant but not clinically relevant differences between APAP and CPAP respectively: Apnea index [1.0 (2.8 +/- 0.8), median (mean +/- standard deviation)] versus [1.8 (5.3 +/- 11.5)], p = 0.004; percentage of N1 sleep [12.3 (15.9 +/- 0.5)] versus [14.3 (18.9 +/- 12.7)], p = 0.028. AHI values differed between PSG [2.8 (5.5. +/- 9.3)] and device [3.7 (6.0 +/- 8.6)], p = 0.003). Regarding residual events detection, intraclass correlation coefficients for AHI were strong (0.956, p < 0.001) and the area under the curve was 0.988 (AHI cut-off value of 10). Conclusions: The new APAP modality was effective and residual apnea-hypopnea indices calculated by the device strongly correlated to those assessed by PSG.
Keywords
POSITIVE AIRWAY PRESSURE, DEVICES, PREVALENCE, TITRATION, MEDICINE, STANDARD, CPAP, APAP, CPAP, residual event detection, sleep apnea

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MLA
Gagnadoux, Frederic, et al. “Validation of the System One RemStar Auto A-Flex for Obstructive Sleep Apnea Treatment and Detection of Residual Apnea-Hypopnea Index: A European Randomized Trial.” JOURNAL OF CLINICAL SLEEP MEDICINE, vol. 13, no. 2, 2017, pp. 283–90, doi:10.5664/jcsm.6464.
APA
Gagnadoux, F., Pevernagie, D., Jennum, P., Lon, N., Loiodice, C., Tamisier, R., … Pepin, J. L. (2017). Validation of the System One RemStar Auto A-Flex for Obstructive Sleep Apnea Treatment and Detection of Residual Apnea-Hypopnea Index: A European Randomized Trial. JOURNAL OF CLINICAL SLEEP MEDICINE, 13(2), 283–290. https://doi.org/10.5664/jcsm.6464
Chicago author-date
Gagnadoux, Frederic, Dirk Pevernagie, Poul Jennum, Nina Lon, Corinne Loiodice, Renaud Tamisier, Petra van Mierlo, et al. 2017. “Validation of the System One RemStar Auto A-Flex for Obstructive Sleep Apnea Treatment and Detection of Residual Apnea-Hypopnea Index: A European Randomized Trial.” JOURNAL OF CLINICAL SLEEP MEDICINE 13 (2): 283–90. https://doi.org/10.5664/jcsm.6464.
Chicago author-date (all authors)
Gagnadoux, Frederic, Dirk Pevernagie, Poul Jennum, Nina Lon, Corinne Loiodice, Renaud Tamisier, Petra van Mierlo, Wojciech Trzepizur, Martina Neddermann, Annika Machleit, Jeffrey Jasko, and Jean Louis Pepin. 2017. “Validation of the System One RemStar Auto A-Flex for Obstructive Sleep Apnea Treatment and Detection of Residual Apnea-Hypopnea Index: A European Randomized Trial.” JOURNAL OF CLINICAL SLEEP MEDICINE 13 (2): 283–290. doi:10.5664/jcsm.6464.
Vancouver
1.
Gagnadoux F, Pevernagie D, Jennum P, Lon N, Loiodice C, Tamisier R, et al. Validation of the System One RemStar Auto A-Flex for Obstructive Sleep Apnea Treatment and Detection of Residual Apnea-Hypopnea Index: A European Randomized Trial. JOURNAL OF CLINICAL SLEEP MEDICINE. 2017;13(2):283–90.
IEEE
[1]
F. Gagnadoux et al., “Validation of the System One RemStar Auto A-Flex for Obstructive Sleep Apnea Treatment and Detection of Residual Apnea-Hypopnea Index: A European Randomized Trial,” JOURNAL OF CLINICAL SLEEP MEDICINE, vol. 13, no. 2, pp. 283–290, 2017.
@article{8690444,
  abstract     = {{Study Objectives: Autotitrating continuous positive airway pressure (CPAP) devices adjust pressure in response to changes in airflow and are an alternative to attended in-laboratory titration polysomnography (PSG) to determine optimal pressure levels. The aim of this study was to compare the performance of the System One RemStar Auto A-Flex (Philips Respironics, Murrysville, PA, USA) automatically adjusted positive airway pressure (APAP) mode to manually titrated, fixed pressure CPAP and to validate the device's breathing event detection capabilities against attended in-laboratory PSG. Methods: Sixty-one patients investigated in five centers for moderate to severe obstructive sleep apnea between May 2012 and June 2013 were invited to participate. Participants underwent two full-night attended polysomnograms in random order with manually titrated, fixed pressure CPAP versus APAP. Results: Fifty-three participants with a mean apnea-hypopnea index (AHI) of 45.9 +/- 23 completed two sleep studies and were included in the analysis. There were significant but not clinically relevant differences between APAP and CPAP respectively: Apnea index [1.0 (2.8 +/- 0.8), median (mean +/- standard deviation)] versus [1.8 (5.3 +/- 11.5)], p = 0.004; percentage of N1 sleep [12.3 (15.9 +/- 0.5)] versus [14.3 (18.9 +/- 12.7)], p = 0.028. AHI values differed between PSG [2.8 (5.5. +/- 9.3)] and device [3.7 (6.0 +/- 8.6)], p = 0.003). Regarding residual events detection, intraclass correlation coefficients for AHI were strong (0.956, p < 0.001) and the area under the curve was 0.988 (AHI cut-off value of 10). Conclusions: The new APAP modality was effective and residual apnea-hypopnea indices calculated by the device strongly correlated to those assessed by PSG.}},
  author       = {{Gagnadoux, Frederic and Pevernagie, Dirk and Jennum, Poul and Lon, Nina and Loiodice, Corinne and Tamisier, Renaud and van Mierlo, Petra and Trzepizur, Wojciech and Neddermann, Martina and Machleit, Annika and Jasko, Jeffrey and Pepin, Jean Louis}},
  issn         = {{1550-9389}},
  journal      = {{JOURNAL OF CLINICAL SLEEP MEDICINE}},
  keywords     = {{POSITIVE AIRWAY PRESSURE,DEVICES,PREVALENCE,TITRATION,MEDICINE,STANDARD,CPAP,APAP,CPAP,residual event detection,sleep apnea}},
  language     = {{eng}},
  number       = {{2}},
  pages        = {{283--290}},
  title        = {{Validation of the System One RemStar Auto A-Flex for Obstructive Sleep Apnea Treatment and Detection of Residual Apnea-Hypopnea Index: A European Randomized Trial}},
  url          = {{http://dx.doi.org/10.5664/jcsm.6464}},
  volume       = {{13}},
  year         = {{2017}},
}

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