R44DA059491

Wearable wireless respiratory monitoring system that detects and predicts opioid induced respiratory depression - project summary.

Opioids are the most prescribed drug in US hospitals, and opioid induced respiratory depression (OIRD) is a widespread and life-threatening problem. Episodes of OIRD on the general hospital floor are common, occurring in up to 46% of patients.

Despite the prevalence of this problem, OIRD has yet to be effectively addressed through monitoring technology. There is great clinical need for a wearable sensor capable of detecting the onset and progression of OIRD with actionable alerts, well before the onset of severe hypoventilation, hypoxemia, cardiac arrhythmia, and death.

To meet this clinical need, RTM VITAL SIGNS, LLC is developing a wearable, wireless respiratory monitoring system (RMS) with an acoustic trachea sound sensor (TSS) and a software algorithm that continuously measures a person’s respiratory rate (RR), tidal volume (TV), minute ventilation (MV), breathing pattern, duration of apnea, oxygen saturation, degree of snoring, heart rate (HR), body position, and activity level.

The RMS algorithm calculates a risk index score (RIS) specifically for OIRD every 20 seconds. RTM has received breakthrough device designation from the FDA to develop the RMS for the prevention of an opioid overdose and death in hospitalized patients, outpatients, and US citizens that chronically use or abuse opioids.

RTM plans to commercialize the RMS first for monitoring hospitalized patients managed with opioids on the general nursing floors, due to the high incidence of OIRD in these environments and the impracticality of using existing methods such as pulse oximetry combined with capnography to provide sufficient monitoring for all patients receiving opioids.

Having already demonstrated feasibility of our technology, we are working to optimize the RMS to handle noisy environments and validate the system in a clinical study.

In Phase 1, we will optimize the existing RMS with dynamic filtering and active noise cancellation software (Phase 1, Aim 1) and conduct a human study using the optimized RMS to measure the accuracy of RR, TV, and apnea duration in a noisy environment with the filtering/noise cancellation software turned on, versus turned off (Phase 1, Aim 2).

In Phase 2, we will construct and bench-test functional RMS prior to a human clinical trial (Phase 2, Aim 1), obtain an FDA investigational device exemption (IDE), and then conduct an observational clinical trial in post-operative surgical patients managed with fentanyl and other opioids to demonstrate RMS’s ability to detect and predict the onset and progression of an OIRD event (N = 120 patients) (Phase 2, Aim 2).

Together, these steps will accomplish key development milestones and clinical testing needed for regulatory approval and commercialization of the RMS device.

Successful completion of this project will produce a commercially viable wearable wireless RMS with the potential to improve the health and safety of patients receiving opioids by accurately detecting and predicting OIRD with actionable alerts prior to the onset of severe hypoventilation, hypoxemia, cardiac arrhythmia, and death.

RTM Vital Signs

TO SUPPORT BASIC AND CLINICAL NEUROSCIENCE, BIOMEDICAL, BEHAVIORAL AND SOCIAL SCIENCE, EPIDEMIOLOGIC, HEALTH SERVICES AND HEALTH DISPARITY RESEARCH. TO DEVELOP NEW KNOWLEDGE AND APPROACHES RELATED TO THE PREVENTION, DIAGNOSIS, TREATMENT, ETIOLOGY, AND CONSEQUENCES OF DRUG ABUSE AND ADDICTION, INCLUDING HIV/AIDS. TO SUPPORT RESEARCH TRAINING AND RESEARCH SCIENTIST DEVELOPMENT. TO SUPPORT DISSEMINATION OF RESEARCH FINDINGS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) LEGISLATION IS INTENDED TO EXPAND AND IMPROVE THE SBIR PROGRAMS TO EMPHASIZE AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF TECHNOLOGY DEVELOPED THROUGH FEDERAL SBIR RESEARCH AND DEVELOPMENT, INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN THE SBIR PROGRAM. THE LEGISLATION INTENDS THAT THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.279 - Drug Abuse and Addiction Research Programs

National Institute on Drug Abuse (NIDA) [HHS - NIH]

Pennsylvania United States

State-Wide

Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants use Disorders (OUD/StUD) (R43/R44 - Clinical Trial Optional) (RFA-DA-23-021)

Amendment Since initial award the End Date has been extended from 03/31/24 to 09/30/24 and the total obligations have increased 409% from $325,601 to $1,657,541.