The evaluation of a novel single-lead biopotential device for home sleep testing.

STUDY OBJECTIVES

This paper reports on the clinical evaluation of the sleep staging performance of a novel single-lead biopotential device.

METHODS

One hundred and thirty-three patients suspected of obstructive sleep apnea were included in a multi-site cohort. All patients underwent polysomnography and received the study device, a single-lead biopotential measurement device attached to the forehead. Clinical endpoint parameters were selected to evaluate the device's ability to determine sleep stages. Finally, the device's performance was compared to the clinical study results of comparable devices.

RESULTS

Concurrent PSG and study device data were successfully acquired for 106 of the 133 included patients. The results of this study demonstrated significant similarity in overall sleep staging performance (five-stage Cohen's Kappa of 0.70) to the best-performing reduced-lead biopotential device to which it was compared (five-stage Cohen's Kappa of 0.73). Contrary to the comparator devices, the study device reported a higher Cohen's Kappa for rapid eye movement (REM) (0.78) compared to N3 (0.61), which can be explained by its particular measuring electrode placement (diagonally across the lateral cross-section of the eye). This placement was optimized to ensure the polarity of rapid eye movements could be adequately captured, enhancing the capacity to discriminate between N3 and REM sleep when using only a single-lead setup.

CONCLUSIONS

The results of this study demonstrate the feasibility of incorporating a single-lead biopotential extension in a reduced-channel home sleep apnea testing setup. Such incorporation could narrow the gap in the functionality of reduced-channel home sleep testing and in-lab polysomnography without compromising the patient's ease of use and comfort.

CLINICAL TRIALS

NCT05035992, A Validation Study of the NightOwl Head Sensor https://clinicaltrials.gov/ct2/show/NCT05035992.