A Comparative Review of Performance and Concurrent Cardiac Rhythm Assessment Across Home Sleep Apnea Testing Devices

Home sleep apnea testing (HSAT) is now widely used in place of in-laboratory polysomnography (PSG) for the evaluation of sleep-disordered breathing (SDB), but published performance varies across FDA-cleared devices. This narrative review aimed to summarize the published performance of FDA-cleared Type III HSAT devices currently marketed in the United States and compare their labeled capabilities for assessing SDB over multiple nights and concurrently evaluating cardiac rhythm and atrial fibrillation (AF) burden. A search of the FDA 510(k) database identified 68 devices with MNR as the primary product code that were cleared after August 1, 2016, or were cleared earlier but released for sale after that date. There were 13 devices that met these criteria and the Centers for Medicare and Medicaid Services (CMS) criteria for a Type III HSAT. For each device, sensitivity and specificity against PSG, scored under American Academy of Sleep Medicine Rule 1B (4% oxygen desaturation), were obtained from the FDA 510(k) Summary or a peer-reviewed validation study. Balanced accuracy (the mean of sensitivity and specificity) was calculated at apnea-hypopnea index (AHI) thresholds of 5, 15, and 30 events per hour. Five devices were excluded from the comparison and are reported for information only because their performance data were not reported using a methodology consistent with that of the other devices: they used a different scoring rule or severity threshold, reported central apnea detection only, or relied on a less credible source for the reported data. Among the remaining eight devices, reported sample sizes ranged from 30 to 476 subjects. All eight reported performance at AHI ≥ 15, five at AHI ≥ 5, and three at AHI ≥ 30. At AHI ≥ 15, balanced accuracy was highest for AcuPebble Ox200 (Acurable Limited, London, UK) (96.5), followed by WatchPAT SW (Itamar Medical, Caesarea, Israel) (94.0) and RX-1 Sleep (Rhythm Express, St. Paul, MN) (92.2). RX-1 Sleep reported the highest balanced accuracy at AHI ≥ 5 (90.9) and AHI ≥ 30 (92.9). These comparisons are indirect and descriptive: each device was validated against PSG in a separate cohort, none was evaluated against another device in the same patients, and between-device differences were not statistically tested. Prospective head-to-head studies against a common reference standard would be needed to confirm differences in relative performance. Among the devices compared, RX-1 Sleep system provides an aid for concurrent assessment of SDB and AF burden in a single test. Other devices can flag or record rhythm information but cannot quantify AF burden. Together with its published performance and multi-night testing capability, this may offer clinical benefit given the severity-dependent association between SDB and AF burden and the elevated cardiovascular risk observed when the two conditions coexist.