CompletedInterventional

Detection of respiratory exacerbations in adults with cystic fibrosis using artificial intelligence

Cystic fibrosis is an inherited condition that causes thick mucus to build up in the lungs, leading to chest infections and flare-ups called exacerbations. Catching these infections early can help prevent long-term lung damage. This trial is testing whether a smartphone app called Breathe RM Signal can spot flare-ups before symptoms begin. Around 400 adults from specialist cystic fibrosis centres across the UK will track their health at home for one year using digital tools, including a breathing meter, scales, and an oxygen sensor. Half of the participants will use standard home tracking, while the other half will also receive a traffic-light warning system powered by artificial intelligence. If the app detects a change, it advises the user to contact their clinic. The goal is to see if this early warning system improves health and day-to-day quality of life.

At a glance

Status

Completed

Sponsor

Papworth Hospital NHS Foundation Trust

Enrolment target

400

Start

12 Jul 2023

Estimated completion

28 Feb 2025

Cystic fibrosis

What is this study about?

Cystic fibrosis (CF) is a lifelong genetic condition that causes thick, sticky mucus to build up in the lungs and digestive system. People living with CF often experience sudden chest flare-ups, known as acute pulmonary exacerbations. These flare-ups can cause lung damage, make breathing difficult, and lead to unplanned hospital stays. Finding ways to catch and treat these infections as early as possible is vital for keeping lungs healthy.

To help tackle this, researchers at Royal Papworth Hospital NHS Foundation Trust have developed a smartphone app called Breathe RM Signal. The app connects wirelessly to simple home monitoring kit, such as a lung function meter (spirometer), an oxygen monitor, and weighing scales. It uses artificial intelligence to look at your daily readings and detect tiny health changes that you might not even feel yet.

The app uses a simple colour system to keep you informed. A green signal means your readings look stable, while amber or red signals suggest a flare-up might be starting and tell you when to contact your care team. Researchers want to find out whether this early warning system helps people get treated sooner, prevents severe illness, and gives people with cystic fibrosis more confidence in managing their health at home.

Key takeaways

Tests an artificial intelligence app designed to spot chest flare-ups early.
Open to adults aged 18 and over who have cystic fibrosis.
Involves tracking your breathing, weight, and oxygen levels at home for one year.
Does not involve any new medicines or changes to your current treatment plan.
Uses a simple traffic-light system to let you know when to contact your care team.
Aims to reduce hospital visits and improve day-to-day quality of life.

Who may be eligible?

This study is open to adults aged 18 and older who have a confirmed diagnosis of cystic fibrosis through genetic tests or a sweat test. You need to be able and willing to carry out simple health checks at home using digital devices, and happy to share your anonymised health data for research.

You cannot take part if you have received a lung transplant, or if you find it difficult to complete regular home monitoring. In addition, you cannot join if you have taken part in another clinical trial testing a new medicine within the last three months.

If you already monitor your health at home, or feel confident that you could manage it, you may be suitable. Your CF specialist team can help confirm whether this trial is a good match for you.

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.

I am aged 18 or older.
I have a confirmed diagnosis of cystic fibrosis.
I have not had a lung transplant.
I am able and willing to use digital health devices at home.
I have not taken part in a trial testing a new medicine in the last 3 months.

Answer every question to see your result.

What does participation involve?

Taking part lasts for one year. You will be given home health tools, including a handheld breathing device, an activity tracker, an oxygen monitor, and weighing scales that link to the Breathe RM app on your smartphone. You will be randomly placed into one of two groups: one group will track their readings normally, while the other group will also receive the traffic-light early warning alerts. No experimental medicines are involved, and your regular cystic fibrosis treatments will carry on as usual. Every three months, you will fill in a 15-minute questionnaire online or on paper about your quality of life and your experience using the app. You may also be invited to join an optional short discussion to give your feedback.

Potential risks and benefits

There are no known physical risks from taking part, as the study does not test any new drugs or medical procedures. Potential benefits include having access to easy home-monitoring equipment and possibly catching chest infections earlier, which can reduce the need for heavier treatments and protect your lungs. However, the app is only a guide and should never replace your own judgement; if you feel unwell, you should always contact your clinic regardless of your app colour. Taking part is completely voluntary, and you are free to leave at any time without any change to your NHS care.

Locations (10)

Royal Papworth Hospital NHS Foundation Trust
City only
Cambridge, England
Belfast Health and Social Care Trust
City only
Belfast, Northern Ireland
Cardiff & Vale University Lhb
City only
Cardiff, Wales
Kings College Hospital
Approximate
London, England
NHS Greater Glasgow and Clyde
City only
Glasgow, Scotland
NHS Lothian
Unverified
Edinburgh, Scotland
Southampton University Hospital
Unverified
Southampton, England
University Hospital of South Manchester NHS Foundation Trust
Unverified
Manchester, England
Leeds Teaching Hospitals NHS Trust
Unverified
Leeds, England
Nottingham University Hospitals NHS Trust - City Campus
Unverified
Nottingham, England

Common questions

Does the app replace my usual hospital visits or care team?

No. The app is a support tool to help you track your health. Your specialist team remains in charge of your care, and you can contact them whenever you feel unwell.

Do I have to pay for the home monitoring equipment?

No. All the equipment, including the spirometer, scales, and oxygen monitor, is provided for free as part of the study.

Will I need to take any new medications?

No. This study only tests the digital app and monitoring tools. You will continue taking your normal cystic fibrosis medications.

What happens if the app gives me a red alert?

A red alert means your health readings suggest a possible flare-up. The app will advise you to get in touch with your CF care team within 48 hours so they can check on you.

Can I leave the study if I change my mind?

Yes. You can withdraw from the study at any time without giving a reason, and it will not affect your standard NHS medical treatment.

How to find out more

Lucy Gale

lucy.gale1@nhs.net +44 1223 638480 Official trial record

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