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Be Part of Research - Trial Details - Using a respiratory monitoring device to reduce drug harm

Using a respiratory monitoring device to reduce drug harm

Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Substance-induced respiratory depression


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The United Kingdom is currently experiencing an opiate drug overdose crisis and we are committed to helping people who are at risk of opiate drug overdose. When someone experiences an overdose, their breathing is slowed to a dangerous, and sometimes fatal level. In the hospital, doctors and nurses can easily monitor patients’ breathing. However, monitoring someone’s breathing in the community, e.g., in a homeless accommodation, hasn’t been possible until now. Technology is available that consists of a small, discreet sensor that sticks to the chest area and monitors chest movement and has the potential to detect when a person is experiencing abnormal breathing relating to an overdose. This device has the potential to alert individuals, household members, friends and family, or emergency services, who can come and give lifesaving naloxone. We want to conduct this study to understand if wearing the device is possible for people who are at risk of overdose, as well as to collect information to understand their normal breathing patterns.
This study is testing if wearing the device is possible for people by looking at the amount of time that data is collected when participants are wearing the sensor and by interviewing participants about their thoughts and feelings about wearing the device. We also want to collect data that can be used to understand normal breathing patterns and patterns that might trigger an emergency response if someone is experiencing an overdose.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

09 Jan 2025 31 Oct 2025

Publications

2025 Protocol article in https://pubmed.ncbi.nlm.nih.gov/40622953/ (added 08/07/2025)

At a participant's first visit, the study will be carefully explained to them by a staff member who works in the accommodation. They will have as much time as they need to think about their participation and following that, if they are happy to take part, they will be asked to sign a consent form.
The study will involve wearing the device overnight if the participant is only staying for a short time or up to 4 weeks if they are staying longer. There is an option to wear the device for longer than 4 weeks, if the accommodation staff suggest it and the participants agrees. The study will last for 1 year, this would be the longest time a participant would be asked to wear the device for. At their first study visit, after agreeing to take part, the staff member will take a brief medical history and take their height and weight measurements to calculate their BMI, as this can impact their breathing pattern. The staff will ask the participant for some information about themselves and ask them to complete a questionnaire about their drug use. The information they provide in this questionnaire will be recorded anonymously with a participant number instead of their name and will be used to demonstrate rates of drug use to overdose risk so that the way the device works can be more effective. They will then be given instructions on how to wear the sensor on their chest area, and staff will explain where the tablet which collects data from the sensor on their chest movement is located in their room. Participants will also be supplied with and instructed on using a paper diary to record when they are taking their drugs and prescription medication. An accommodation worker will check in on participants at least once in an evening to make sure they are wearing the device, it is working correctly and they are safe.
Participants will be required to wear the sensor continuously while they are in the accommodation but should remove it and leave it in their room if they are going out. If they forget and leave the sensor on when they go out, the sensor light will flash red until it comes back into range of the tablet. If they are leaving the accommodation permanently, they should return the device to an accommodation worker. Participants should swap the side of chest the device is on once a week.
Participant data will not be monitored during the study. All analysis will be carried out after the study is completed.
After each 4-week period (or after their first evening if they are a short-stay resident), they will be asked to complete a satisfaction survey to highlight any issues with wearing the sensor.
During the participants' last study visit, they will return the device, tablet and diary. They will be asked if they would like to take part in an interview and/or focus group about their experiences, thoughts and feelings on wearing the device. They may also be asked about their thoughts on the development of an intervention pathway (creating the most effective way to refer people and encourage people to wear the device) using the device to trigger an emergency response if someone is experiencing an overdose.


People over 18 years of age who use drugs who live in supported accommodation

You can take part if:



You may not be able to take part if:


1. Does not meet one or more of the inclusion criteria2. Skin sensitivity to ECG electrode patch3. Broken skin over chest area4. Implanted pacemaker device in-situ5. Not suitable for enrolment in the opinion of site staff or investigators


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Hillcrest Homes
    1 North Grimsby
    Arbroath
    DD1 1NU
  • Gowrie Care
    67 Portman Street
    Glasgow
    G41 1EJ
  • Hillcrest Futures
    1 St John's Hill The Pleasance
    Edinburgh
    EH11 1DQ
  • Martha Jones House
    Wendle Court 131-137 Wandsworth Road
    London
    SW8 2LH
  • St Mungo's
    83 Endell Street
    London
    WC2H 9DN
  • St Mungo's
    12-14 Endsleigh Gardens
    London
    WC1H 0EH
  • St Mungo's
    Mare Street Hackney 146 Mare Street
    London
    E8 3SG
  • No Second Night Out
    Discovery House 133 Barkerend Road
    Bradford
    BD3 9AU

There is zero to minimal risk to participants from the biosensor itself. It may be mildly uncomfortable to wear initially but participants should soon become used to it. Several Clinical Research projects have been conducted with the technology (e.g., RESCU: RESpiratory monitoring reduCing drUg harm, IRAS 301153) with over 150 participants and 15,000 hours of wear. No adverse events related to the biosensor have been reported.
There is no risk of personal data being revealed via the DC Mobile software. All chest movement data is anonymous.
Participants are people who actively use drugs and may be at risk of accidental overdose. Supported accommodation sites involved in the study have trained staff to administer naloxone, to reverse the effects of an opioid overdose or to administer first aid. Participants will be informed that the device will not issue an alert in the event of a potential overdose. Supported accommodation staff perform regular wellness checks on residents who show signs of drug use throughout the evening. Staff will continue to perform these checks on study participants, so there is no change to the risk of accidental overdose.
Sites provide advice and additional services to help residents stop using opiates and other drugs. Participants will not be disincentivised from using these services.
The study will not immediately benefit participants, but if the results of the study are positive, it may lead to a future study in which we would develop an intervention pathway that uses the device to potentially trigger an emergency response if a person is experiencing an overdose.
For taking part in the study, participants will be offered £25 per week over the 4 weeks they wear the device, providing they have been wearing it and the tablet is still in their room and working. If they are a short-stay participant, they will receive £5 each time they return the device and tablet the morning after use – up to a maximum total of £25. If they take part in an interview, they will receive £20. If they take part in a focus group, they will receive £10. Where possible, payment will be made by using the Cash Out system. Participants will receive a text message they can show at any shop with a PayPoint sign to receive the cash value. If they do not have a mobile telephone, they will be paid in cash or receive a shopping voucher of the same value.


The study is sponsored by University of Dundee and funded by Scottish Government.




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Read full details for Trial ID: ISRCTN12060022
Last updated 18 August 2025

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