SBIR-STTR Award

Development of a Tracheal Sound Sensor for Early Detection of Hypoventilation Due to Opioid Overdose.
Award last edited on: 1/9/20

Sponsored Program
STTR
Awarding Agency
NIH : NIDA
Total Award Amount
$236,381
Award Phase
1
Solicitation Topic Code
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Principal Investigator
Jeffrey I Joseph

Company Information

RTM Vital Signs LLC

439 Dreshertown Road
Fort Washington, PA 19034
   (215) 643-1286
   info@rtmvitalsigns.com
   www.rtmvitalsigns.com

Research Institution

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Phase I

Contract Number: 1R41DA047779-01
Start Date: 5/15/19    Completed: 4/30/20
Phase I year
2019
Phase I Amount
$236,381
More than 64,000 Americans died from drug overdose in 2016 and drug overdose is now the most common cause of death for people under 50 years old in the United States. Furthermore, the number of overdose deaths is increasing with the rise of abuse of powerful synthetic opioids, such as fentanyl. In May of 2017 National Institutes of Health (NIH) and National Institute on Drug Abuse (NIDA) directors Drs. Collins and Volkow outlined how research may help reduce the death toll associated with the current opioid epidemic; one of the current critical needs is the development of new overdose-reversal interventions, including wearable technologies that can detect an (impending) overdose from physiological signals to signal for help, or trigger a coupled automated injection of naloxone. Automated detection of overdose is essential because most opioid overdoses occur when individuals are alone and unobserved by family members or first responders. Opioids cause respiration to slow and become irregular due to mu-opioid receptor mediated suppression of respiratory related regions of the brainstem and spinal cord. Importantly, there are characteristic early changes in breathing pattern that indicate a progression towards significant hypoventilation, but there is currently no easy-to –use method or device to measure these patterns non-invasively. Recently, there has been a renewed interest in respiratory monitoring using tracheal sounds. Tracheal sounds originate from the vibrations of the tracheal wall and surrounding soft tissues caused by gas pressure fluctuations in the trachea. These sounds can be collected from a microphone placed over the trachea and analyzed to determine the real-time respiratory rate and an estimate of respiratory flow and tidal volume. We hypothesize that individual trends in tracheal sounds detected by a machine- learning algorithm will provide an early warning sign of the onset of hypoventilation as a result of opioid overdose in humans. The aims of this proposal are to develop a machine learning algorithm that detects impending hypoventilation due to an opioid overdose and to develop an initial design for a miniature wireless tracheal sound sensor.

Public Health Relevance Statement:
Project Narrative RTM Vital Signs, LLC is developing a non-invasive Tracheal Sound Sensor for early detection of impending hypoventilation due to an opioid overdose. The sensor will continuously monitor an individual’s respiratory pattern to detect a significant change from baseline, in which case it will contact a caregiver and/or emergency personnel detailing the location and status of the person experiencing an opioid overdose or initiate a coupled naloxone injection. This technology has the potential to prevent a significant number of deaths as a result of opioid overdose by allowing for the timely detection of hypoventilation and administration of naloxone.

Project Terms:
Abdomen; Accelerometer; Adult; airway obstruction; alertness; Algorithms; American; base; Body Patterning; body position; Brain Stem; Breathing; Caliber; Caregivers; Cause of Death; Cellular Phone; Cessation of life; Characteristics; Clinical; clinical predictors; clinically significant; Coupled; Data; design; Detection; Development; Devices; Diagnostic; Disease; Early Diagnosis; Emergency Medical Technicians; emergency service responder; Engineering; engineering design; Environmental air flow; experience; experimental study; Family member; Fentanyl; first responder; Future; Gases; Goals; Head; high risk; Human; Hypercapnic respiratory failure; Hypoxemia; indexing; Individual; Infusion procedures; Injections; interest; Intervention; learning strategy; Location; Machine Learning; machine learning algorithm; Measures; Mediating; Methods; microphone; Modeling; Monitor; Movement; mu opioid receptors; Naloxone; National Institute of Drug Abuse; Noise; notch protein; Opioid; opioid abuse; opioid epidemic; opioid overdose; Outpatients; Overdose; overdose death; Patients; Pattern; Performance; Persons; Pharmaceutical Preparations; Phase; phase 2 study; Physiological; prediction algorithm; pressure; prevent; programs; Protocols documentation; Research; Respiration; respiratory; Risk; Sedation procedure; sensor; signal processing; Signal Transduction; Skin; Small Business Innovation Research Grant; Small Business Technology Transfer Research; smartphone Application; Snoring; soft tissue; Sorbus; sound; Spinal Cord; Study Subject; Subcutaneous Tissue; Substance abuse problem; synthetic opioid; System; Technology; Telemetry; Thick; Tidal Volume; Time; time use; Tooth structure; Trachea; trend; United States; United States National Institutes of Health; Universities; Validation; Vendor; vibration; volunteer; wearable technology; Wireless Technology; W

Phase II

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
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Phase II Amount
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