Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 18, 2024
Date Accepted: Jul 9, 2024
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Overdose detection among high-risk opioid users via a wearable chest sensor in a Supervised Injecting Facility: Study protocol for an observational study
ABSTRACT
Background:
Opioid overdose is a global health crisis, affecting over 27 million individuals worldwide, with more than 100,000 drug overdose deaths in the USA in 2022-2023. This protocol outlines the development and validation of the PneumoWave DC chest biosensor, a wearable device designed to detect respiratory depression in real-time through chest motion measurement, intending to enhance early intervention and thereby reduce fatalities.
Objective:
The study aims to: 1) differentiate opioid-induced respiratory depression (OIRD) from non-fatal opioid use patterns to develop and refine an overdose detection algorithm; 2) examine acceptability of the chest biosensor to participants.
Methods:
The study adopts an observational design over a six-month period. The biosensor, a small device, will be worn by consenting participants during injecting events to capture chest motion data. Safe Injecting Facilities (SIF) in Sydney (Site 1) and Melbourne (Site 2), which are legally-sanctioned space where individuals can use pre-obtained illicit drugs under medical supervision. Each site is anticipated to recruit up to 100 participants who inject opioids and attend the SIF. Participants will wear the biosensor during supervised injecting events at both sites. The biosensor will capture data on an anticipated 40 adverse drug events. The biosensor’s ability to detect OIRD will be compared to the staff-identified events that use standard protocols for managing overdoses. Measurements will include: 1) chest wall movement measured by the biosensor, securely streamed to a cloud, and analysed to refine an overdose detection algorithm; 2) acute events/potential overdose identified by site staff.
Results:
As of January 2024, 47 participants have been enrolled and data from 1,145 injecting events have already been collected, including 10 overdose events. The study is expected to be finalised by early March 2024.
Conclusions:
This protocol establishes a foundation for advancing wearable technology in opioid overdose prevention within SIFs. The study will provide chest wall movement data and associated overdose data that will be used to train an algorithm that allows biosensor to detect an overdose. The study will contribute crucial insights into OIRD, emphasising the biosensor's potential step forward in real-time intervention strategies.
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