Assess the real-world performance of ANNE Sleep system against two FDA-cleared home sleep testing platforms and the intraindividual night-to-night variability of respiratory event index (REI) measured by ANNE Sleep.

We evaluated the home performance ANNE Sleep system compared with two FDA-cleared home sleep testing platforms (WatchPAT: n=29 and Alice NightOne: n=46) during a synchronous night with unsupervised patient application. Additionally, we evaluated night-to-night variability of REI and total sleep time using the ANNE Sleep system (n=30).

For the diagnosis of moderate and severe OSA, the ANNE Sleep system had a positive percent agreement of 58% (95% CI 28-85%) and a negative percent agreement of 100% (95% CI 80-100%) compared to WatchPAT. The positive and negative percent agreement for ANNE Sleep versus Alice NightOne was 85% (95% CI 66-96%) and 95% (95% CI 74-100%). There were no differences in mean total sleep time or REI across multiple nights of monitoring with ANNE. There were no differences consistent with a first night effect but testing multiple nights reclassified OSA severity in 5 (17%) individuals and detected 3 additional cases of moderate disease, with only a 12% (SD 28%) mean fluctuation in REI from first night of testing compared to a mean of multiple nights. Overall, 80% of users found ANNE comfortable and easy to use.

ANNE Sleep exhibited stronger concordance with Alice NightOne compared to WatchPAT. While we illustrated low night-to-night variability for ANNE Sleep, the results suggest multiple nights increased detection of moderate or severe OSA.