Not yet recruitingOBSERVATIONAL

Structured Light Plethysmography Against Standard of Care in the Diagnosis and Monitoring of Dysfunctional Breathing

This study is investigating a new scanning device called Thora3Di™ to help diagnose and monitor a condition called 'dysfunctional breathing'. This condition can make people feel breathless even when other causes, like asthma, have been ruled out. Researchers want to see if the Thora3Di™ scan can provide more information about how people breathe, compared to the standard tests currently used. It's an observational study, meaning participants will be monitored, but won't receive a new treatment. The goal is to see how accurate and useful this new scanning method is for people experiencing unexplained breathlessness. There's also a smaller group of healthy volunteers taking part to provide comparison data.

At a glance

Status

Not yet recruiting

Sponsor

Pneumacare Ltd

Enrolment target

Start

01 Oct 2025

Estimated completion

01 Oct 2026

Dysfunctional Breathing

What is this study about?

This study is trying to understand more about a condition called 'dysfunctional breathing'. This is when you feel breathless, but doctors can't find an obvious medical reason for it, like lung disease or heart problems. It can be quite frustrating and can impact daily life.

The researchers are testing a new device called Thora3Di™. This device uses a special light to measure how your chest moves when you breathe, giving a detailed picture of your breathing patterns. The study wants to see how well this new Thora3Di™ scan works compared to the usual tests doctors currently use to diagnose and monitor dysfunctional breathing. The main aim is to find out if this new scan can help doctors better understand why some people feel breathless and how to best help them.

There are two main groups in the study. One group includes adults who experience this kind of unexplained breathlessness. The other group is made up of healthy adults who don't have breathing problems. By comparing the breathing patterns of both groups, researchers hope to learn more about dysfunctional breathing and how the Thora3Di™ device could be used in the future to help patients in the UK.

Key takeaways

The study tests a new breathing scanner called Thora3Di™.
It aims to improve diagnosis of unexplained breathlessness (dysfunctional breathing).
Participants will have monitoring visits and breathing scans, not new treatments.
Healthy volunteers are also needed for comparison.
It could help improve future understanding and care for breathlessness.
You can withdraw from the study at any time.

Who may be eligible?

To join the main part of the study (Cohort A), you need to be an adult between 16 and 75 years old who is experiencing breathlessness without a clear cause, and other common medical conditions like uncontrolled asthma or heart problems have been ruled out or are well-managed. We need to make sure your breathlessness isn't due to another ongoing, active health issue.

There's also a group for healthy volunteers (Cohort B). For this, you would need to be an adult within the same age range who generally has good breathing health and no significant health problems.

However, you wouldn't be able to join if you can't sit upright for the short measurement periods, or if you have certain health conditions like severe spine or chest problems, severe sleep apnoea, or other serious illnesses that the study doctor thinks could affect your safety or the study results. You also can't take part if you are pregnant, breastfeeding, or planning to become pregnant, or if your BMI (Body Mass Index) is over 40, or if you are taller than 194 cm. All participants must be able to understand and agree to the study procedures.

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.

Are you between 16 and 75 years old?
Do you experience breathlessness, but other medical causes have been ruled out or are well-managed?
Can you sit upright comfortably for a short period?
Are you not pregnant, breastfeeding, or planning a pregnancy during the study?
Is your BMI (Body Mass Index) less than 40?
(For healthy volunteers) Do you consider yourself generally healthy with no significant breathing issues?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the main group (Cohort A), you would have four visits to the clinic over roughly six months. Before your first study visit, you'd have a screening visit within two weeks. At each of your main four visits (at the beginning, after 13 weeks, and after 26 weeks), you'd have two short Thora3Di™ scans, each lasting about 5 minutes – one while you're resting and one after some light activity. These scans would happen before any other lung tests, so they shouldn't add much extra time to your hospital visit. You'll also be asked about any medicines you're taking, if you've had any side effects, and you'll fill out a few questionnaires.

If you're in the healthy volunteer group (Cohort B), you would only have one visit. After agreeing to take part, you'd have the same two 5-minute Thora3Di™ scans (at rest and after light activity). No follow-up visits or extra questionnaires are required for this group.

Potential risks and benefits

Taking part in this study won't offer a direct medical benefit to you immediately, as it's observational and aims to improve future diagnosis for others. However, you would be helping researchers learn more about dysfunctional breathing and how to improve care for people with this condition. The Thora3Di™ scan is not expected to cause any harm, as it simply uses light to measure your breathing. There are no known risks associated with the scans. You are free to withdraw from the study at any time without giving a reason, and this won't affect your usual medical care.

Locations (1)

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

Pneuma Care Ltd
Verified postcode
Ely, United Kingdom

Common questions

What is dysfunctional breathing?

It's when you feel breathless, but doctors can't find a clear medical reason for it, like lung or heart disease.

What is Thora3Di™?

It's a new device that uses special light to measure how your chest moves when you breathe, giving a detailed picture of your breathing patterns.

Will I get any treatment in this study?

No, this is an 'observational' study, meaning we're just collecting information. You won't receive any new treatments as part of the study.

How long will I need to be in the study if I have breathlessness?

If you join the main group, you'll have four visits over about six months.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without giving a reason, and it won't affect your medical care.

How to find out more

Gin Lee

gin.lee@pneumacare.com +44 1223 967418 Official trial record

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