Abstract Rationale Despite night-to-night variability in obstructive sleep apnea (OSA), the need to objectively monitor treatment efficacy, and momentum to incorporate metrics that have better predictive value than apnea-hypopnea index, pulse oximeter devices suitable for multi-night monitoring that calculate risk-based metrics such as sleep apnea-specific hypoxic burden (SASHB) are not readily available. ProSomnus Sleep Technologies (Pleasanton, CA) has developed a buccal mucosal reflectance pulse oximeter embedded in a custom-fitted overlay of the upper teeth. The accuracy of the buccal mucosal oximeter’s SpO2 signal was previously validated in a controlled desaturation study (Snow et al., 2025). Since the purpose of the buccal mucosal oximeter device is to provide multi-night monitoring of OSA, the device would benefit from the addition of metrics such as SASHB, which can be calculated from the SpO2 signal. The purpose of the current analysis was to validate the accuracy of the SASHB calculated by the buccal mucosal oximeter device against a previously validated method. Methods Data from two previous prospective clinical trials were used in the analysis. In the trials, type 3 home sleep tests were conducted prior to and following initiation of oral appliance therapy. Data from 190 technically adequate nights were processed through the buccal mucosal oximeter’s software and a previously validated reference SASHB calculator. Results The buccal mucosal oximeter software produced values that correlated strongly with the reference calculator for both 3% SASHB (r = 0.97; p .0001) and 4% SASHB (r = 0.97, p .0001). Bland-Altman analysis showed a bias of 0.77 and upper and lower 95% limits of agreement of 26.99 and -25.45, respectively, for 3% SASHB and a bias of 6.34 and upper and lower 95% limits of agreement of 33.84 and -21.17, respectively, for 4% SASHB. Conclusions The data show that the buccal mucosal oximeter device’s software algorithm produces a measure of sleep apnea-specific hypoxic burden that agrees well with that from a validated reference calculator. The ability of the buccal mucosal oximeter to produce an accurate SASHB will allow for risk-based monitoring of OSA and treatment efficacy. Further studies are needed to validate the metric in situ against a gold standard. This abstract is funded by: ProSomnus Sleep Technologies
Mosca et al. (Fri,) studied this question.