450 Cellular Energy Monitoring for Diagnosis and Management of Therapy for Sleep Disordered Breathing

Abstract

Abstract Introduction Polysomnogram (PSG) monitoring, including pulse oximetry, is the current diagnostic standard in sleep medicine. However, potentially confounding aspects of PSG testing include: test site other than the subject’s normal bed, distracting sensors and wires, subjective interpretation of complex recorded signals, and limited sensitivity to relevant phenomena. There is currently an unmet need for a sleep test that is more clinically effective than PSG, and that can be administered in the subject’s normal sleeping environment. Additionally, confirmation that home therapy has been optimized cannot be achieved by PSG titration. Methods A recent proof of concept (POC) study of the armband-wearable Reveal Cellular Energy Monitor (CE monitor) directly compared its data product, Cellular Energy Index (CEi), with PSG data. Scoring methods were adapted from AASM guidance for interpretation of PSG data. At-home recording with the CE monitor was also performed prior to and following PSG studies. At-home incremental adjustment of APAP settings and mask selection was documented with CE monitoring and compared with the information recorded by the home APAP machine. Results The comparison of the POC data consistently found the CE monitor to be more sensitive and responsive to hypoxic stress than the PSG pulse oximeter during primary snoring. Obstructive and central apnea events were detected by both, but the CE monitor provided finer resolution of the breath-by-breath effort of breathing compared with PSG RIP and nasal sensors. At-home CE monitor optimization of therapy was documented to often differ from the settings and mask selection determined by PSG titration, and resulted in ‘normal’ sleep breathing data. Conclusion All diagnostically-relevant physiologic responses detected by PSG were also detected by the CE monitor. Evidence of cellular hypoxia in the skin, by CE monitor, was consistently recorded during prolonged periods of ‘primary snoring;’ i.e., SpO2 is less sensitive to hypoxic stress during sleep than CEi. Breath-by-breath effort is detected by the CE monitor. Support (if any) The POC study costs at UCSF were paid by Reveal Biosensors, Inc.