[Glasgow, Scotland – Monday 23rd September, 2024]
https://www.researchprotocols.org/2024/1/e57367
A joint paper was published in JMIR Research Protocols, vol 13 (2024), detailing the OD-SEEN (Overdose Sensor Detection amongst high-risk opioid users in a Medically Supervised Injection Centre) study, an observational study with high-risk opioid users in Sydney and Melbourne, Australia.
Opioid overdose is a global health crisis, affecting over 27 million individuals worldwide, with more than 100,000 drug overdose deaths in the United States in 2022-2023. The published protocol outlines the development of the PneumoWave chest biosensor, a wearable device being designed to detect Opioid Induced Respiratory Depression (OIRD) in real time through chest motion measurement, intending to enhance early intervention and thereby reduce fatalities.
The study adopts an observational design over a 6-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 Melbourne, Victoria (site 1), and Sydney, New South Wales (site 2), which are legally sanctioned spaces 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 attempt to 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.
Acceptability will be measured by a feedback questionnaire as many times as the participant is willing to throughout the study.
The aim of the study is to:
- Differentiate opioid-induced respiratory depression (OIRD) from nonfatal opioid use patterns to develop and refine an overdose detection algorithm
- Examine participants’ acceptability of the chest biosensor.
As of April 2024, PneumoWave has enrolled 47 participants and gathered data from 1,145 injecting events, including 10 overdose cases. Data analysis is ongoing.
The study will provide chest wall movement data and associated overdose data that will be used to train an algorithm that allows the biosensor to detect an overdose. The study will contribute crucial insights into OIRD, emphasizing the biosensor’s potential step forward in real-time intervention strategies in the treatment of opioid use disorder (OUD).
PneumoWave’s technology addresses a significant challenge in the OUD treatment landscape in the USA —poor patient retention in Medication Assisted Treatment (MAT). Sixty-four percent (64%) of OUD patients drop out of MAT before completing the 12-month NIDA (National Institute of Drug Abuse) recommended retention period, often due to withdrawal symptoms, co-occurring mental health disorders, and insufficient visibility into patient health outside clinical settings. By providing monitoring of respiratory function and health status during opioid use, PneumoWave’s technology aims to enhance adherence to treatment protocols and improve long-term patient outcomes, both in-person and through virtual care models.
Dr Bruce Henderson, Chief Executive Officer of PneumoWave, commented:
“It is a privilege to be part of the OD-SEEN study, learning new insights into the catastrophic problem of overdose – now the largest cause of accidental death in most developed countries. Partnering with independent, world-leading academic centres as we develop our technology with the aim of preventing deaths by optimising management, the study has enabled us to apply our technology in a unique environment, capturing data from over 1100 events. This data is generating new insights into the physiological consequences of accidental overdose and, with very positive feedback from patients, has taken us a substantial step closer to achieving our goal that no one should die from this devastating problem.”
About PneumoWave
PneumoWave’s proprietary digital technology and behavioral health platform provides real-time physiological data via patient-centric digital biomarkers with the core focus of preventing deaths and reducing hospital admissions from respiratory failure.
Through early and accurate detection of respiratory depression and facilitating rapid access to overdose reversal agents, PneumoWave aims to markedly reduce deaths in patients at risk of accidental overdose.
The device is part of a wider remote digital behavioral health platform that aims to provide physicians and care teams with a range of validated digital technologies that will enable more effective and efficient assessment and remote management of patients. Given the shortage of physicians, surging hospital costs, and proven difficulties for patients in accessing treatment, PneumoWave has the potential to drive optimal, life-saving outcomes for patients.
Disclaimer
PneumoWave’s software has been granted breakthrough device designation but is not yet cleared by the FDA.
About King’s College London and the Institute of Psychiatry, Psychology & Neuroscience
King’s College London is one of the top 35 UK universities in the world and one of the top 10 in Europe (QS World University Rankings, 2020/21) and among the oldest in England. King’s has an outstanding reputation for world-class teaching and cutting-edge research. The Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s is the premier centre for mental health and related neurosciences research in Europe. It produces more highly cited outputs (top 1% citations) on mental health than any other centre (SciVal 2019) and on this metric we have risen from 16th (2014) to 4th (2019) in the world for highly cited neuroscience outputs. World-leading research from the IoPPN has made, and continues to make, an impact on how we understand, prevent and treat mental illness and other conditions that affect the brain.
www.kcl.ac.uk/ioppn @KingsIoPPN
About Uniting MSIC
The Uniting Medically Supervised Injection Centre in King’s Cross, Sydney, provides a safe, non-judgmental environment where people who inject drugs can self‐administer substances in hygienic conditions under the supervision of qualified staff. The MSIC was opened in 2001, and has since supervised 1.28 million injections, with no fatalities. In addition, MSIC provides clients with referrals to services such as healthcare, drug treatment and social welfare.
https://www.uniting.org/community-impact/uniting-medically-supervised-injecting-centre–msic
For further information on the study, contact:
John Strang, MBBS, MD
National Addiction Centre
Institute of Psychiatry, Psychology and Neuroscience
King’s College London
Addiction Sciences Building
London, SE5 8BB
United Kingdom
Phone: 44 2078480438
Email: john.strang@kcl.ac.uk
For further information on PneumoWave’s technology: