# Wearable Wireless Respiratory Monitoring System that Detects and Predicts Opioid Induced Respiratory Depression

> **NIH NIH R44** · RTM VITAL SIGNS, LLC · 2024 · $55,000

## Abstract

PROJECT SUMMARY FOR THE PREDICATE GRANT. 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 dete...

## Key facts

- **NIH application ID:** 10986772
- **Project number:** 3R44DA059491-01S1
- **Recipient organization:** RTM VITAL SIGNS, LLC
- **Principal Investigator:** Magdalena Kirlakovsky Bosak
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $55,000
- **Award type:** 3
- **Project period:** 2024-02-01 → 2024-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10986772

## Citation

> US National Institutes of Health, RePORTER application 10986772, Wearable Wireless Respiratory Monitoring System that Detects and Predicts Opioid Induced Respiratory Depression (3R44DA059491-01S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10986772. Licensed CC0.

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