Feasibility and Form Factor Validation of Reflective Shoulder-Mounted Pulse Oximeter in Patients with Suspected Sleep Apnea.

The shoulder may be an effective central site for continuous oxygen saturation (SpO2) monitoring but studies of shoulder-mounted pulse oximetry technology are limited. We hypothesized that an alternative location would be similar in function and user acceptance to a standard FDA-cleared finger-based pulse oximeter. We conducted a quantitative and descriptive pilot study of two prototype biosensor designs in patients with clinical suspicion of hypoxic episodes at an outpatient sleep center. Participants wore two prototype biosensors-the primary a shoulder-mounted adhesive and the secondary a combination ring-bracelet-in addition to a control FDA-approved finger-based pulse oximeter. We assessed the comfort of the devices based on a survey. We monitored 27 patients during an overnight polysomnography study. Participants rated the shoulder-mounted device more highly than the control device on a Likert scale survey of comfort (4.6 out of 5 versus 3.1 out of 5). Open-ended questionnaires showed that the two major criticisms of the control and ring devices were devices falling off and disruption to sleep, while only one participant commented on the shoulder device specifically. We also investigated SpO2 agreement between the primary shoulder-mounted prototype and the control finger-based pulse oximeter. This study confirms that alternative configurations for SpO2 monitoring offer potential as well-tolerated devices with preliminary findings of acceptable agreement. Problems with traditional pulse oximetry, such as false readings of hypoxia due to device removal or noisy data, were encountered less frequently in shoulder-mounted pulse oximetry than in the commercial finger-based device. Future directions include studies of additional populations that are at risk of respiratory collapse and surveys to elicit specific feedback on the configurations, whether positive or negative.