A multicentric validation study of a novel home sleep apnea test based on peripheral arterial tonometry
| Autor: | Bart Van Pee, Frederik Massie, Steven Vits, Pauline Dreesen, Susie Klerkx, Jagdeep Bijwadia, Johan Verbraecken, Jeroen Bergmann |
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| Přispěvatelé: | Van Pee, Bart/0000-0001-5075-188X, Van Pee, Bart, Massie, Frederik, Vits, Steven, DREESEN, Pauline, Klerkx, Susie, Bijwadia, Jagdeep, Verbraecken, Johan, Bergmann, Jeroen |
| Rok vydání: | 2022 |
| Předmět: |
Sleep Apnea
Obstructive Manometry Polysomnography nervous system diseases respiratory tract diseases Sleep Apnea Syndromes peripheral arterial tonometry Physiology (medical) mental disorders Humans Human medicine Neurology (clinical) home sleep apnea testing sympathetic tonedouble-scoring Arousal endpoint design |
| Zdroj: | Sleep |
| ISSN: | 1550-9109 0161-8105 |
| DOI: | 10.1093/sleep/zsac028 |
| Popis: | Study Objectives This paper reports on the multicentric validation of a novel FDA-cleared home sleep apnea test based on peripheral arterial tonometry (PAT HSAT). Methods One hundred sixty-seven participants suspected of having obstructive sleep apnea (OSA) were included in a multicentric cohort. All patients underwent simultaneous polysomnography (PSG) and PAT HSAT, and all PSG data were independently double scored using both the recommended 1A rule for hypopnea, requiring a 3% desaturation or arousal (3% Rule), and the acceptable 1B rule for hypopnea, requiring a 4% desaturation (4% Rule). The double-scoring of PSG enabled a comparison of the agreement between PAT HSAT and PSG to the inter-rater agreement of PSG. Clinical endpoint parameters were selected to evaluate the device's ability to determine the OSA severity category. Finally, a correction for near-boundary apnea-hypopnea index values was proposed to adequately handle the inter-rater variability of the PSG benchmark. Results For both the 3% and the 4% Rules, most endpoint parameters showed a close agreement with PSG. The 4-way OSA severity categorization accuracy of PAT HSAT was strong, but nevertheless lower than the inter-rater agreement of PSG (70% vs 77% for the 3% Rule and 78% vs 81% for the 4% Rule). Conclusions This paper reported on a multitude of robust endpoint parameters, in particular OSA severity categorization accuracies, while also benchmarking clinical performances against double-scored PSG. This study demonstrated strong agreement of PAT HSAT with PSG. The results of this study also suggest that different brands of PAT HSAT may have distinct clinical performance characteristics. The data acquisition of this study was sponsored by Ectosense prior to its acquisition by ResMed. We wish to thank the team of United Health Systems Group and the ZOL sleep laboratories for their expertise and assistance in data acquisition. All authors have seen and approved the manuscript. Institution where work was performed: University of Oxford. Frederik Massie, Bart Van Pee, and Steven Vits are employed by ResMed, the manufacturer of the NightOwl HSAT device. Dr. Jagdeep Bijwadia receives medical advisory fees from Ectosense (a company now wholly owned by ResMed) which are not in direct relation to this clinical study. |
| Databáze: | OpenAIRE |
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