Device-Agnostic Hypoxia Detection Software for Overdose Prediction and Positive Reversal Monitoring

ABSTRACT / PROJECT SUMMARY Despite the availability of naloxone, opioid overdoses claim 84,181 lives annually in the U.S., with an additional hidden toll of non-fatal opioid overdoses (NFOO) leading to hypoxia-induced brain injuries. Opioid-induced respiratory depression (OIRD) remains the primary cause of hypoxia-related brain injuries, which can lead to long-term neurological impairments such as encephalopathy, cognitive deficits, and motor dysfunction. These injuries begin within four minutes of hypoxia onset, while EMS response times average over nine minutes. Furthermore, ~52% of overdoses occur when the individual is alone, and even in the presence of bystanders, 27% fail to recognize the difference between opioid use and a potentially fatal overdose. To address this, DOVE combines an innovative shoulder-wearable sensor with device-agnostic software to predict fatal overdoses and facilitate effective reversal interventions. DOVE integrates advanced algorithms that analyze SpO2 levels, respiratory rates, and motion patterns, delivering real-time verbal feedback akin to an automated external defibrillator (AED). This guidance enables responders—whether harm reduction volunteers, EMS, or law enforcement—to administer tailored interventions, such as naloxone redosing or bag-valve-mask (BVM) ventilation. Importantly, DOVE addresses challenges posed by novel substances like xylazine, which impede respiratory recovery and render naloxone insufficient. BVM, a preferred alternative among 105 harm reduction stakeholders interviewed during NIH I-Corps, offers a more humane and effective means of restoring oxygenation in complex overdose scenarios. The project encompasses a one-year Phase I to build on our I-Corps participation to validate commercialization potential. Phase I focuses on developing device-agnostic software for hypoxia monitoring and validating biomarkers for overdose prediction and reversal. This includes stakeholder feedback, feasibility analysis, and FDA guidance, laying the groundwork for Phase II clinical trials.