Active not recruitingNAINTERVENTIONAL

Obstructive Sleep Apnoea and Cardiac Arrhythmias

This study is investigating the link between sleep apnoea and problems with heart rhythm. We know that people with sleep apnoea are more likely to have heart disease and irregular heartbeats. Sometimes, these heart issues aren't picked up by standard tests. This research will involve 200 people with sleep apnoea. Up to 100 of them will have a small heart monitor (Reveal LINQ) placed under their skin to continuously check for irregular heartbeats for three years. The other 100 will receive their usual care. By closely monitoring heart rhythms, we hope to understand how common these problems are and if better monitoring can lead to improved ways of managing sleep apnoea to protect heart health.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Enrolment target

200

Start

03 Oct 2019

Estimated completion

15 Apr 2025

Obstructive Sleep Apnea Cardiovascular Diseases Arrhythmia Atrial Fibrillation New Onset

What is this study about?

This study wants to learn more about how sleep apnoea affects your heart, especially your heart's rhythm. You might already know that sleep apnoea, where your breathing stops and starts repeatedly during sleep, can put a lot of stress on your body. This stress can lead to serious health problems over time, including high blood pressure, heart issues, and even an increased risk of strokes.

We also know that people with sleep apnoea are much more likely to develop irregular heartbeats, often called arrhythmias. Even if you're using treatments like CPAP for your sleep apnoea, there can still be a higher risk of heart problems. Currently, standard heart checks, like a 24-hour heart monitor (Holter monitor) or an ECG, might not always catch these irregular heartbeats because they aren't constantly monitoring over a long period. This means some potentially dangerous heart rhythm problems could be missed.

This research aims to see how often these irregular heartbeats happen in people with sleep apnoea. By understanding this better, we can work towards finding new and improved ways to manage sleep apnoea in the future. The ultimate goal is to improve treatments that help protect your heart and overall health if you have sleep apnoea.

Key takeaways

Exploring the link between sleep apnoea and irregular heartbeats.
Using a small, implanted monitor to continuously check heart rhythm.
Aims to detect heart problems missed by standard tests.
May lead to improved future treatments for sleep apnoea patients.
Study involves 200 participants with sleep apnoea.

Who may be eligible?

To be part of this study, you need to be a patient with moderate to severe sleep apnoea and already using a CPAP machine for treatment. You also need to be between 18 and 75 years old.

There are some reasons why you wouldn't be able to join. For example, if you've already been diagnosed with certain irregular heartbeats like atrial fibrillation (AF), atrial flutter, or something called ventricular tachycardia (VT), you wouldn't be eligible. Also, if you already have one of the special heart monitors we're using, or if there's a medical reason you need one for something else, you can't join.

Finally, if your doctor has given you a diagnosis that suggests you have less than three years to live, or if you're unable to understand and agree to take part in the study, you would also not be able to participate.

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 moderate or severe sleep apnoea?
Are you currently using a CPAP machine?
Are you between 18 and 75 years old?
Have you NOT been diagnosed with atrial fibrillation or similar heart rhythm problems?
Do you NOT already have an implanted heart monitor?
Are you able to understand and give your agreement to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be one of 200 participants. Up to half of the participants (100 people) will have a small device called a Reveal LINQ inserted under the skin of their chest. This device is very small and will continuously monitor your heart's rhythm for three years. The other half of the participants will continue with their usual medical care. Both groups will have additional assessments, including blood tests, special heart scans (magnetocardiography and echocardiography), which are tests that look at your heart's electrical signals and its structure. Any significant heart problems found during the study will be treated according to standard NHS guidelines. The study doesn't mention specific visit schedules, but continuous monitoring means occasional check-ups for the device and for the additional tests.

Potential risks and benefits

Taking part in this study offers potential benefits. By using the Reveal LINQ, we might be able to detect irregular heartbeats that standard tests miss, potentially leading to earlier treatment. The information we gather could also help improve future care for all people with sleep apnoea, leading to better heart health outcomes. Potential risks include those associated with the minor procedure to implant the heart monitor, such as a small amount of pain, bruising, or a very low risk of infection. You are free to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

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

University Hospital Coventry & Warwickshire
Verified postcode
Coventry, United Kingdom

Common questions

What is sleep apnoea?

Sleep apnoea is a condition where your breathing repeatedly stops and starts while you're asleep, often causing snoring and tiredness.

What is an irregular heartbeat (arrhythmia)?

An irregular heartbeat means your heart isn't beating in a steady, regular rhythm as it should.

What is a Reveal LINQ device?

It's a tiny, implantable heart monitor, about the size of a triple-A battery, that's placed under your skin to continuously record your heart's electrical activity.

Will I know if the device detects something?

Yes, if the device detects a significant abnormality, your doctors will be informed and will treat it according to standard NHS guidelines.

What happens after the 3 years of monitoring?

The information gathered over the three years will help researchers understand the link between sleep apnoea and heart problems. Your medical team will discuss what happens with the device after this period.