Wearable In-Ear Encephalography Sensor for Monitoring Sleep. Preliminary Observations from Nap Studies

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Rationale To date, EEG is the only quantifiable measure of the neural changes that define sleep. Although it is used widely for clinical testing, scalp-electrode EEG is costly and is poorly tolerated by sleeping patients. Objectives This was a pilot study to assess the agreement between EEG recordings obtained from a new ear-EEG sensor and those obtained simultaneously from standard scalp electrodes. Methods Participants were four healthy men, 25 to 36 years of age. During naps, EEG tracings were recorded simultaneously from the ear sensor and from standard scalp electrodes. A clinical expert, blinded to the data collection, analyzed 30-second epochs of recordings from both devices, using standardized criteria. The agreement between scalp- and ear-recordings was assessed. Measurements and Main Results We scored 360 epochs (scalp-EEG and ear-EEG), of which 254 (70.6%) were scored as non–REM sleep using scalp-EEG. The ear-EEG sensor had a sensitivity of 0.88 (95% confidence interval [CI], 0.82–0.92) and a specificity of 0.78 (95% CI, 0.70–0.84) in detecting N2/N3 sleep. The kappa coefficient between the scalp- and the ear-EEG was 0.65 (95% CI, 0.58–0.73). As a sleep monitor (all non–REM sleep stages vs. wake), the in-ear sensor had a sensitivity of 0.91 (95% CI, 0.87–0.94) and a specificity of 0.66 (95% CI, 0.56–0.75). The kappa coefficient was 0.60 (95% CI, 0.50–0.69). Conclusions Substantial agreement was observed between recordings derived from a new ear-EEG sensor and conventional scalp electrodes on four healthy volunteers during daytime naps.