Wrist Of Participants Research Articles

Prospective clinical validation of the Empatica EmbracePlus wristband as a reflective pulse oximeter.

Respiratory diseases such as chronic obstructive pulmonary disease, obstructive sleep apnea syndrome, and COVID-19 may cause a decrease in arterial oxygen saturation (SaO2). The continuous monitoring of oxygen levels may be beneficial for the early detection of hypoxemia and timely intervention. Wearable non-invasive pulse oximetry devices measuring peripheral oxygen saturation (SpO2) have been garnering increasing popularity. However, there is still a strong need for extended and robust clinical validation of such devices, especially to address topical concerns about disparities in performances across racial groups. This prospective clinical validation aimed to assess the accuracy of the reflective pulse oximeter function of the EmbracePlus wristband during a controlled hypoxia study in accordance with the ISO 80601-2-61:2017 standard and the Food & Drug Administration (FDA) guidance. Healthy adult participants were recruited in a controlled desaturation protocol to reproduce mild, moderate, and severe hypoxic conditions with SaO2 ranging from 100% to 70% (ClinicalTrials.gov registration #NCT04964609). The SpO2 level was estimated with an EmbracePlus device placed on the participant's wrist and the reference SaO2 was obtained from blood samples analyzed with a multiwavelength co-oximeter. The controlled hypoxia study yielded 373 conclusive measurements on 15 subjects, including 30% of participants with dark skin pigmentation (V-VI on the Fitzpatrick scale). The accuracy root mean square (Arms) error was found to be 2.4%, within the 3.5% limit recommended by the FDA. A strong positive correlation between the wristband SpO2 and the reference SaO2 was observed (r = 0.96, P < 0.001), and a good concordance was found with Bland-Altman analysis (bias, 0.05%; standard deviation, 1.66; lower limit, -4.7%; and upper limit, 4.8%). Moreover, acceptable accuracy was observed when stratifying data points by skin pigmentation (Arms 2.2% in Fitzpatrick V-VI, 2.5% in Fitzpatrick I-IV), and sex (Arms 1.9% in females, and 2.9% in males). This study demonstrates that the EmbracePlus wristband could be used to assess SpO2 with clinically acceptable accuracy under no-motion and high perfusion conditions for individuals of different ethnicities across the claimed range. This study paves the way for further accuracy evaluations on unhealthy subjects and during prolonged use in ambulatory settings.

Shape Recognition With Sounds: Improvement in Sighted Individuals After Audio-Motor Training.

Recent studies have demonstrated that audition used to complement or substitute visual feedback is effective in conveying spatial information, e.g., sighted individuals can understand the curvature of a shape when solely auditory input is provided. Recently we also demonstrated that, in the absence of vision, auditory feedback of body movements can enhance spatial perception in visually impaired adults and children. In the present study, we assessed whether sighted adults can also improve their spatial abilities related to shape recognition with an audio-motor training based on the idea that the coupling of auditory and motor information can further refine the representation of space when vision is missing. Auditory shape recognition was assessed in 22 blindfolded sighted adults with an auditory task requiring participants to identify four shapes by means of the sound conveyed through a set of consecutive loudspeakers embedded on a fixed two-dimensional vertical array. We divided participants into two groups of 11 adults each, performing a training session in two different modalities: active audio-motor training (experimental group) and passive auditory training (control group). The audio-motor training consisted in the reproduction of specific movements with the arm by relying on the sound produced by an auditory source positioned on the wrist of participants. Results showed that sighted individuals improved the recognition of auditory shapes only after active training, suggesting that audio-motor feedback can be an effective tool to enhance spatial representation when visual information is lacking.