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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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. / Gagnadoux, Frédéric; Pevernagie, Dirk; Jennum, Poul; Lon, Nina; Loiodice, Corinne; Tamisier, Renaud; van Mierlo, Petra; Trzepizur, Wojciech; Neddermann, Martina; Machleit, Annika; Jasko, Jeffrey; Pépin, Jean Louis.
In: Journal of Clinical Sleep Medicine, Vol. 13, No. 2, 2017, p. 283-290.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Validation of the System One RemStar Auto A-Flex for Obstructive Sleep Apnea Treatment and Detection of Residual Apnea-Hypopnea Index
T2 - A European Randomized Trial
AU - Gagnadoux, Frédéric
AU - Pevernagie, Dirk
AU - Jennum, Poul
AU - Lon, Nina
AU - Loiodice, Corinne
AU - Tamisier, Renaud
AU - van Mierlo, Petra
AU - Trzepizur, Wojciech
AU - Neddermann, Martina
AU - Machleit, Annika
AU - Jasko, Jeffrey
AU - Pépin, Jean Louis
N1 - © 2017 American Academy of Sleep Medicine
PY - 2017
Y1 - 2017
N2 - 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.COMMENTARY: A commentary on this article appears in this issue on page 167.
AB - 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.COMMENTARY: A commentary on this article appears in this issue on page 167.
KW - Apnea/physiopathology
KW - Continuous Positive Airway Pressure/instrumentation
KW - Cross-Over Studies
KW - Double-Blind Method
KW - Europe
KW - Female
KW - Humans
KW - Male
KW - Middle Aged
KW - Polysomnography
KW - Reproducibility of Results
KW - Sleep Apnea, Obstructive/physiopathology
U2 - 10.5664/jcsm.6464
DO - 10.5664/jcsm.6464
M3 - Journal article
C2 - 27784415
VL - 13
SP - 283
EP - 290
JO - Journal of Clinical Sleep Medicine
JF - Journal of Clinical Sleep Medicine
SN - 1550-9389
IS - 2
ER -
ID: 195157948