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 -