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Difficulty falling asleep is one of the typical insomnia symptoms. However, intervention therapies available nowadays, ranging from pharmaceutical to hi-tech tailored solutions, remain ineffective due to their lack of precise real-time sleep tracking, in-time feedback on the therapies, and an ability to keep people asleep during the night. This paper aims to enhance the efficacy of such an intervention by proposing a novel sleep aid system that can sense multiple physiological signals continuously and simultaneously control auditory stimulation to evoke appropriate brain responses for fast sleep promotion. The system, a lightweight, comfortable, and user-friendly headband, employs a comprehensive set of algorithms and dedicated own-designed audio stimuli. Compared to the gold-standard device in 883 sleep studies on 377 subjects, the proposed system achieves (1) a strong correlation (0.89 ± 0.03) between the physiological signals acquired by ours and those from the gold-standard PSG, (2) an 87.8% agreement on automatic sleep scoring with the consensus scored by sleep technicians, and (3) a successful non-pharmacological real-time stimulation to shorten the duration of sleep falling by 24.1 min. Conclusively, our solution exceeds existing ones in promoting fast falling asleep, tracking sleep state accurately, and achieving high social acceptance through a reliable large-scale evaluation. 

The Earable device is a behind-the-ear wearable originally developed to measure cognitive function. Since Earable measures electroencephalography (EEG), electromyography (EMG), and electrooculography (EOG), it may also have the potential to objectively quantify facial muscle and eye movement activities relevant in the assessment of neuromuscular disorders. As an initial step to developing a digital assessment in neuromuscular disorders, a pilot study was conducted to determine whether the Earable device could be utilized to objectively measure facial muscle and eye movements intended to be representative of Performance Outcome Assessments, (PerfOs) with tasks designed to model clinical PerfOs, referred to as mock-PerfO activities. The specific aims of this study were: To determine whether the Earable raw EMG, EOG, and EEG signals could be processed to extract features describing these waveforms; To determine Earable feature data quality, test re-test reliability, and statistical properties; To determine whether features derived from Earable could be used to determine the difference between various facial muscle and eye movement activities; and, To determine what features and feature types are important for mock-PerfO activity level classification. A total of N = 10 healthy volunteers participated in the study. Each study participant performed 16 mock-PerfOs activities, including talking, chewing, swallowing, eye closure, gazing in different directions, puffing cheeks, chewing an apple, and making various facial expressions. Each activity was repeated four times in the morning and four times at night. A total of 161 summary features were extracted from the EEG, EMG, and EOG bio-sensor data. Feature vectors were used as input to machine learning models to classify the mock-PerfO activities, and model performance was evaluated on a held-out test set. Additionally, a convolutional neural network (CNN) was used to classify low-level representations of the raw bio-sensor data for each task, and model performance was correspondingly evaluated and compared directly to feature classification performance. The model’s prediction accuracy on the Earable device’s classification ability was quantitatively assessed. Study results indicate that Earable can potentially quantify different aspects of facial and eye movements and may be used to differentiate mock-PerfO activities. Specially, Earable was found to differentiate talking, chewing, and swallowing tasks from other tasks with observed F1 scores >0.9. While EMG features contribute to classification accuracy for all tasks, EOG features are important for classifying gaze tasks. Finally, we found that analysis with summary features outperformed a CNN for activity classification. We believe Earable may be used to measure cranial muscle activity relevant for neuromuscular disorder assessment. Classification performance of mock-PerfO activities with summary features enables a strategy for detecting disease-specific signals relative to controls, as well as the monitoring of intra-subject treatment responses. Further testing is needed to evaluate the Earable device in clinical populations and clinical development settings.