0457 Cardiopulmonary Coupling as an alternative to classic Home Sleep Apnea Testing: Head to Head Assessment
Abstract Introduction Standard HSATs directly measure airflow and chest-movements to diagnose OSA. Indirect measures such as Cardiopulmonary-Coupling (CPC) now FDA approved as “Software-as-a-medical-device” are gaining utilization. The FDA assessment of CPC was from NPSG oximetry recordings to which...
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Published in | Sleep (New York, N.Y.) Vol. 46; no. Supplement_1; pp. A203 - A204 |
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Main Authors | , , , , |
Format | Journal Article |
Language | English |
Published |
29.05.2023
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Online Access | Get full text |
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Summary: | Abstract
Introduction
Standard HSATs directly measure airflow and chest-movements to diagnose OSA. Indirect measures such as Cardiopulmonary-Coupling (CPC) now FDA approved as “Software-as-a-medical-device” are gaining utilization. The FDA assessment of CPC was from NPSG oximetry recordings to which it was compared. SleepImage (SI) recently made CPC commercially available using ring-based oximetry. Out of lab “real-life” validation or head-to-head comparisons of SI-CPC-ring based HSATs to traditional nasal cannula / strain gauge sensor HSTs has ever been published. We performed a Head-to-head study of SI-CPC Ring system to two different HSTs, ApneaLink (AL) by ResMed and Z-Machine (ZM) by General Sleep Corporation. The ZM also provides an EEG derived assessment of sleep stage.
Methods
Patients undergoing AL or ZM HSAT studies were simultaneously placed on SI-CPC-ring devices. Statistical assessments consisted of Bland-Altman-plots and correlation-coefficients to assess for similarity of these devices. Here we report 3%AHI (analogous to the 1A AHI) and 4% AHI analogous to the 1B AHI). Additionally Total-Sleep-Time(TST) and Sleep Efficency(Slp-Eff) are reported with the ZM, which utilized EEG to provide these parameters.
Results
AL-vs-SI-CPC N=44. ZM-vs-SI-CPC N=50. The Bland-Altman-plot and correlation-coefficients demonstrates SI-CPC provided statistically similar results. AL-3%AHI ( Ⴟ 20.3, +/-21.8) vs SI-sAHI3% ( Ⴟ 24.2, +/-25.2) MD: -6.641 (CI -10.127 to -3.154) Range 3.800 to 110.000, R= 0.923 AL-4%AHI (Ⴟ 15.8 +/-21.4 ) vs SI-sAHI4% (Ⴟ 15.8 +/-25.5) MD: 0.132 (CI -2.489 to 2.753) Range 0.000 to 105.600, R= 0.952 ZM-3%AHI (Ⴟ 15.2 +/-30.0) vs SI-sAHI3% (Ⴟ 13.8 +/-19.4) MD: 1.334 (CI -2.709 to 5.377) Range -27.121 to 29.789 R=0.92 ZM-4%AHI (Ⴟ 1.5 +/-27.7) vs SI-sAHI4% (Ⴟ 8.9 +/-17.4) MD: 1.598 (CI -1.917 to 5.113) Range -23.135 to 26.331 R=0.95 ZM-TST (Ⴟ 355 +/-92) vs SI-TST (Ⴟ 355 +/-86.0) MD: 0.076 (CI -24 to 24) Range -171 to 171 R=0.59 ZM-Slp-Eff (Ⴟ 0.818 +/-0.115) vs SI-Slp-Eff (Ⴟ 0.826 +/-0.120) MD: -0.008 (CI -0.044 to 0.027) Range -0.258 to 0.241 R=0.44
Conclusion
HSATs with SI-CPC-ring is an easier method to administer than HSATs using air-flow and chest-sensors. This head-to-head study may enhance adoption of this type of testing, using indirect measures since the SI-CPC-ring system is not inferior, as demonstrated in our study.
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ISSN: | 0161-8105 1550-9109 |
DOI: | 10.1093/sleep/zsad077.0457 |