RecruitingOBSERVATIONAL

Non-contact Proactive Remote Monitoring of COPD Exacerbations

This study, for people with a lung condition called COPD, is looking into new ways to spot flare-ups (exacerbations) earlier. Researchers want to see if a special device, called DistaSense, can detect these changes while you sleep, even before you notice any symptoms yourself. The device sits under your mattress and monitors your body. The study also aims to work out which body signals are the best clues for an upcoming flare-up and how this information compares to the results you get from answering a daily health questionnaire. The main goal is to find out if early detection can help manage COPD more effectively.

At a glance

Status

Recruiting

Sponsor

Life Detection Technologies

Enrolment target

Start

15 May 2023

Estimated completion

15 May 2026

COPD Exacerbation

What is this study about?

This study is designed for individuals living with Chronic Obstructive Pulmonary Disease (COPD) and focuses on a common problem: flare-ups, also known as exacerbations. These flare-ups can make your breathing much worse and often lead to hospital visits.

The main idea behind this research is to see if we can detect these flare-ups very early on, possibly even before you start to feel unwell. To do this, the study uses a new device called DistaSense. This device is placed under your mattress while you sleep and monitors your body without touching it. The researchers want to understand what subtle changes in your body might signal an upcoming flare-up.

They will compare the information from the DistaSense device with your daily answers to a health questionnaire called a CAT (COPD Assessment Test). By doing this, they hope to discover if the device can indeed give an earlier warning sign than simply relying on how you feel. Ultimately, the aim is to find better ways to manage COPD and potentially help people get treatment sooner during a flare-up.

Key takeaways

The study aims to detect COPD flare-ups early.
It uses a device under your mattress called DistaSense.
You'll also complete a daily health questionnaire.
The goal is to find better ways to manage COPD.
Participation is at home with no extra clinic visits.

Who may be eligible?

To join this study, you need to have a confirmed diagnosis of COPD. You should also have experienced at least one COPD flare-up in the past year.

Participants must be 18 years old or older and be able to understand and speak English. You'll also need to be willing to use the monitoring device and fill out some study questionnaires. Before you can join, you'll need to read and sign a consent form, which explains everything about the study.

There are a few reasons why you might not be able to join. For example, if you are pregnant, or if your body mass index (BMI) is very high (over 45 kg/m2), you wouldn't be able to take part. Otherwise, if you meet the main criteria, you should be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have a diagnosis of COPD?
Have you had at least one COPD flare-up in the last year?
Are you 18 years old or older?
Are you able to speak and understand English?
Are you NOT pregnant and your BMI is not over 45?

Answer every question to see your result.

What does participation involve?

If you take part in this study, your main activity will be to place a device called DistaSense under your mattress before you go to sleep each night. This device will monitor your body discreetly while you sleep. You'll also be asked to complete a short health questionnaire, called a CAT, every day. This typically involves answering a few questions about how you’re feeling. There are no special medications or extra doctor visits required for this study beyond your usual care. The exact total duration of your participation is not specified but it would involve continuous monitoring and daily questionnaire completion over a period decided by the researchers.

Potential risks and benefits

There are no major known risks associated with taking part in this study, as the DistaSense device simply sits under your mattress without touching you. You might find completing the daily questionnaire a small inconvenience. The potential benefit is that this research could lead to better ways of detecting COPD flare-ups earlier in the future, which could improve care for people with COPD. While there is no direct personal benefit guaranteed, you are contributing to important medical research. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal Free Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is a COPD flare-up?

A COPD flare-up, also called an exacerbation, is when your breathing suddenly gets much worse, and you might have more cough or mucus. It often needs extra treatment.

How does the DistaSense device work?

The DistaSense device sits under your mattress and monitors your body while you sleep, without touching you. It's looking for tiny changes that might show a flare-up is starting.

Do I need to go to special appointments?

No, you don't need extra doctor visits for this study. You just use the device at home and fill in a daily questionnaire.

What is a CAT questionnaire?

The CAT (COPD Assessment Test) is a short questionnaire you fill out each day to describe how your COPD is affecting you.

Can I stop taking part in the study?

Yes, you can stop taking part in the study at any time if you wish, and it won't affect your normal medical care.

How to find out more

Eric Howie

ehowie@distasense.com 4084213151 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.