0695 Comparison of a Disposable Home Sleep Apnea Test to Polysomnography in Patients Referred for Obstructive Sleep Apnea Investigation

Abstract Introduction In an effort to decrease cost and improve healthcare efficiency for the diagnosis of OSA, home sleep apnea tests (HSAT) continue to be developed and improved to enhance diagnostic accuracy. A disposable FDA cleared HSAT capable for multi-night evaluations, that uses peripheral arterial tonometry (PAT) to assess for sleep apnea. The form factor and care pathway have a strong appeal for a patient’s experience of the diagnostic journey. The data obtained from the study informs the strengths, weaknesses, and reliability of new HSAT technology in the clinical management of sleep apnea. Methods A prospective, open-label, single group study was conducted in a certified PSG sleep lab. Patients underwent a single overnight PSG study with concurrent disposable HSAT (NightOwl Mini, Ectosense) testing. The patient population were adults referred to a sleep lab for investigation of OSA. PSG recorded sleep time of ≥4hrs was required to be evaluable. The primary endpoint was clinical decision agreement for treatment, based on AHI threshold ≥15 events/hour. Pairwise comparisons were performed against PSG, and agreement was assessed using Cohen’s Kappa statistic. Results A total of 50 participants completed the study. There were 42 participants included in the analysis. The disposable HSAT had a Kappa value of 0.667 (95% CI 0.448, 0.886) for the clinical decision for treatment compared to PSG, which represents substantial agreement. The sensitivity and specificity were 0.769 and 0.938, respectively. For AHI, the disposable HSAT had a Spearman rank correlation of 0.903 with PSG. OSA severity categorization (based on AASM definitions), was also assessed, with disposable HSAT showing a weighted Kappa value of 0.646 (95% CI 0.501, 0.792). A limitation of this study was the single night use since the HSAT recommends multiple nights for a more accurate assessment. Conclusion A disposable HSAT was found to have substantial agreement with PSG’s clinical decision for treatment based on AHI values, despite the assessment being from a single night as opposed to multiple night usage. The performance and form factor make it an attractive HSAT to assess for sleep apnea and facilitate OSA diagnosis. Support (If Any) ResMed