A multicentric validation study of a novel home sleep apnea test based on peripheral arterial tonometry

Sleep

article

Van Pee, Bart¹  Massie, Frederik¹  Vits, Steven²  Dreesen, Pauline³  Klerkx, Susie⁴  Bijwadia, Jagdeep⁵  Verbraecken, Johan⁶  Bergmann, Jeroen¹ 

[1] Department of Engineering, Natural Interaction Lab, Thom Building, University of Oxford;Faculty of Medicine and Health Sciences, University of Antwerp;Future Health Department, Ziekenhuis Oost-Limburg, Genk, Belgium and Mobile Health Unit, Faculty of Health and Life Sciences, Hasselt University;Department of Pneumology;Department of Pulmonary Critical Care and Sleep Medicine, University of Minnesota;Department of Pulmonary Medicine and Multidisciplinary Sleep Disorders Centre, Antwerp University Hospital;Research Group LEMP, Faculty of Medicine and Health Sciences, University of Antwerp

关键词: home sleep apnea testing;    peripheral arterial tonometry;    sympathetic tone;    double-scoring;    endpoint design;   

DOI  :  10.1093/sleep/zsac028

学科分类：生理学

来源: American Academy of Sleep Medicine

【 摘 要 】

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.

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