Diagnostic agreement between a wireless patch-based and in-lab polysomnography for assessment of sleep-disordered breathing

Background The gold standard for sleep monitoring is in-lab polysomnography (PSG), which is expensive, time-consuming and requires specialized equipment. Onera Health has developed the first wireless patch-based PSG system, the Onera STS, which consists of four body-worn patches that record full PSG outside of a hospital setting. The objective of this study was to validate the Apnea-Hypopnea-Index (AHI) from the Onera STS against in-lab PSG.

Methods A total of 18 patients with a suspected sleep disorder (mean±SD: 91% male, age 44.9±13.9 years, body mass index 27.2±4.6 kg/m²) underwent a one-night simultaneous in-laboratory PSG and Onera STS recording at a sleep clinic in Germany. Study data were blind scored by a single technician according to American Academy of Sleep Medicine criteria. Diagnostic agreement between the Onera STS and PSG was calculated using the following criteria¹:

• Any paired result AHI>30=diagnostic agreement

• In-laboratory PSG AHI<30 and a deviation of≤10=underestimation

• In-laboratory PSG AHI<30 and a deviation>10=overestimation

Results The difference between the average AHI recorded with the Onera STS and the reference PSG was not statistically or clinically relevant (Onera STS AHI 20.1±15.2 (mean±SD) vs. PSG AI 19.9±18.0, difference -0.2±5.8, p=0.91), and a high correlation between the AHI calculated using the two devices was found (r² 0.91, p<0.0001). The AHI from the Onera STS was in diagnostic agreement with a simultaneously recorded reference PSG in 100% of the studies performed.

Conclusion There was 100% diagnostic agreement in the AHI when calculated using signals recorded from the Onera STS and in-lab PSG. The Onera STS can be used by sleep specialists for reliably determining the AHI in patients with suspected sleep-disordered breathing, such as obstructive sleep apnea.

1. White DP, Gibb TJ, Wall JM, Westbrook PR. Assessment of accuracy and analysis time of a novel device to monitor sleep and breathing in the home. Sleep. 1995;18:115–126

Publication History

Article published online:
09 March 2023