Ambulatory ECG monitor versus standard care in acute unexplained syncope (sudden loss of consciousness also known as blackout or fainting)
Every year, over 600,000 people across the UK visit emergency departments after fainting or having a blackout. Often, by the time doctors examine you, your heart rate and rhythm have returned to normal. This makes it difficult to uncover what caused the episode. The ASPIRED study aims to find out if wearing a lightweight, mobile heart monitor for up to 14 days helps doctors diagnose the cause more quickly. Half of the participants receive the wearable monitor alongside standard NHS care, while the other half receive standard care alone. Researchers will follow all participants for two years using very short monthly check-ins. The goal is to see if this monitor leads to better diagnoses, prevents future blackouts or injuries, eases anxiety, and reduces unnecessary hospital visits in the future.
At a glance
What is this study about?
Fainting or suffering a sudden blackout (known medically as syncope) can be a scary experience. In the UK, hundreds of thousands of people go to emergency departments each year for this reason. A major challenge is that most people recover quickly, meaning tests done at the hospital often look completely normal. As a result, doctors frequently cannot tell you why the blackout happened.
This trial investigates a small, wearable heart monitor called the BodyGuardian Mini. It sticks gently to the chest and continuously records your heart rhythm for up to 14 days as you go about your normal daily routine. By monitoring your heart over a longer period, doctors have a much higher chance of spotting an irregular heartbeat that comes and goes.
Researchers want to see if using this monitor right after an emergency hospital visit leads to quicker, more accurate answers. Catching heart rhythm issues early can help doctors start the right treatments, which may prevent future falls, injuries, and hospital stays. The results will help the NHS decide the best way to care for people who experience unexplained blackouts.
Key takeaways
- Tests whether a 14-day stick-on heart monitor helps diagnose unexplained blackouts faster than usual NHS care.
- Open to people aged 16 and over who attended hospital for an unexplained blackout.
- Participants are randomly assigned to either receive the monitor or receive standard NHS care.
- Follow-up lasts two years and is done comfortably from home via quick monthly texts, emails, or calls.
- Funded by the British Heart Foundation and led by NHS Lothian and the University of Edinburgh.
Who may be eligible?
You may be able to join this study if you are 16 or older and recently visited an emergency department or hospital unit because of a sudden blackout, but initial tests could not find a clear cause. You must live locally within the participating NHS health board area and have had fewer than five blackouts in the past month.
You will not be able to participate if doctors have already found an obvious reason for your faint. Common known causes include simple fainting (like feeling faint from heat, needles, or standing too long), a sudden drop in blood pressure when standing, an epileptic seizure, low blood sugar, a head injury, or drinking alcohol. People who have had five or more blackouts in the past four weeks, or who cannot give informed consent, are also excluded.
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 16 years of age or older.
- I attended hospital or A&E recently after fainting or having a blackout.
- Doctors could not find an obvious reason for my blackout during my initial assessment.
- I have had fewer than five blackouts in the past month.
- I live locally within the participating NHS hospital area.
What does participation involve?
Taking part lasts for two years and starts while you are in hospital. A computer randomly places you into one of two groups. If you are in the first group, a nurse or doctor will fit a small heart monitor to your chest to wear for up to 14 days at home, alongside standard hospital care. If you are in the second group, you will receive standard hospital care, which might include normal follow-up appointments or routine heart tests.
After leaving the hospital, you do not need to attend extra hospital visits just for the study. Instead, researchers will contact you once a month by text, email, or telephone to answer two quick questions about your health. You will also be asked to fill out a short questionnaire about your daily life and well-being at the start, after one year, and after two years.
Potential risks and benefits
Locations (46)
- Royal Infirmary of EdinburghApproximateEdinburgh, Scotland
- Taunton HospitalApproximateTaunton, England
- NHS FifeCity onlyKirkcaldy, Scotland
- Royal London HospitalApproximateLondon, England
- St George's HospitalApproximateLondon, England
- Southampton General HospitalUnverifiedSouthampton, England
- Queen Elizabeth University HospitalUnverifiedGlasgow, Scotland
- St Johns HospitalUnverifiedLivingston, Scotland
- AddenbrookesUnverifiedCambridge, England
- John Radcliffe HospitalUnverifiedOxford, England
- Royal Berkshire HospitalUnverifiedReading, England
- Derriford HospitalUnverifiedPlymouth, England
Common questions
What is the monitor and does it hurt to wear?
The monitor is a small, lightweight device that sticks to your skin using a medical adhesive pad. It is painless, non-invasive, and designed to be worn discreetly under your clothes.
Can I choose whether I get the 14-day monitor?
No. A computer randomly assigns participants to either the monitor group or the standard care group. This fair comparison is essential to see if the device genuinely improves care.
Will taking part require lots of extra hospital visits?
No. Once you leave hospital, the follow-up is done remotely using brief monthly text messages, emails, or phone calls, alongside occasional online or paper questionnaires.
Can I carry on with my normal activities while wearing the monitor?
Yes. The device is designed to track your heart during your regular everyday routine, including light exercise, work, and sleep. The hospital team will provide instructions on how to manage bathing and showering.
What happens if the monitor detects an irregular heartbeat?
The information is promptly reviewed and shared with hospital specialists so they can contact you and arrange any further checks, appointments, or treatments you might need.
How to find out more
Rachel Locherty
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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