TinnSpire: Personalised vagus nerve & sound stimulation for the treatment of tinnitus
Do you hear ringing or buzzing in your ears that won't go away? This new study, called TinnSpire, is looking at a different way to help people with ongoing tinnitus. Many current treatments don't always offer enough relief. TinnSpire combines three approaches: gentle electrical stimulation near the ear, personalised sound therapy through headphones, and controlled breathing exercises. The main goal of this first study is to check if this combined treatment is safe, practical, and well-received by people who have had tinnitus for a while. The findings will then help plan a bigger study in the future to see how much it can really help.
At a glance
What is this study about?
Imagine hearing sounds like ringing, buzzing, or hissing when there's no actual noise around – that's tinnitus. It's a common condition that can be very frustrating and upsetting for many people. While several treatments exist, they don't always provide enough relief for everyone.
This study is trying out a new combined approach called TinnSpire. It uses three different methods together: gentle electrical zaps around the ear, sounds played through headphones that are made just for you, and slow, calming breathing exercises. Researchers want to see if putting these three things together can make a positive difference for people with long-term tinnitus. This is an early study, and the main aim is to find out if this new approach is safe to use, easy for people to complete, and something they would be happy to try. The results from this small study will help the researchers plan a larger study later on to properly test how well it works.
The study is being run by experts at Brighton and Sussex Medical School along with University Hospitals Sussex NHS Foundation Trust. It's funded by the National Institute for Health and Care Research in the UK, showing its importance. The study visits will take place in Brighton and Worthing, England.
Key takeaways
- This study evaluates a new combined treatment for long-term tinnitus.
- It involves ear stimulation, sound therapy, and breathing exercises.
- The main goal is to check if the new treatment is safe and practical.
- Participation includes clinic visits, hearing tests, and questionnaires.
- Potential benefits are not guaranteed, and risks are generally low.
- You can stop participating at any point if you choose.
Who may be eligible?
You might be able to join this study if you are 18 years or older and have had tinnitus (ringing or buzzing in your ears) for at least six months. Your tinnitus symptoms should be at a moderate level, not too mild or extremely severe. You also need to be able to understand and speak English.
However, some things would mean you can't take part. For example, if you have certain ear problems (like severe hearing loss, active ear infections, or Meniere's disease), or if you have specific heart conditions, certain nerve conditions (like Parkinson's or epilepsy), or severe mental health conditions. You also can't participate if you have medical devices implanted in your body (like a pacemaker) or if you are pregnant. If you have skin issues affecting your ear, breathing problems, or are on certain medications like beta-blockers, you might also not be able to join. The researchers will check all of these points carefully.
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 18 years old or older?
- Have you had tinnitus for at least 6 months?
- Is your tinnitus moderately bothersome?
- Can you understand and speak English?
- Do you *not* have a pacemaker or other implanted medical device?
- Are you *not* pregnant?
What does participation involve?
If you join, the study will last for about 18 weeks in total. First, you'll have two in-person visits at the clinic. These will involve some hearing tests and filling out questionnaires to understand your tinnitus. After these first visits, you'll attend eight treatment sessions at a clinic over four weeks. Each session will last about 40 to 50 minutes. During these sessions, you'll receive mild electrical stimulation around your ear, listen to sounds tailored for you through headphones, and learn slow breathing exercises.
You'll also be asked to fill out some questionnaires at home at different times: before you start treatment, after you finish the treatment sessions, and again later as a follow-up. You'll be involved in total for a few months, with regular visits to the clinic for treatments during one month of that time.
Potential risks and benefits
Locations (2)
- University Hospitals Sussex NHS Foundation TrustUnverifiedWorthing, England
- University of SussexUnverifiedSussex, England
Common questions
What exactly is tinnitus?
Tinnitus is when you hear sounds like ringing, buzzing, or hissing in your ears or head, even when there's no outside noise.
What is 'gentle electrical stimulation'?
It's a mild electrical current applied to a specific area around your ear, which is thought to help calm nerves linked to tinnitus.
How long does each treatment session last?
Each treatment session at the clinic will last about 40 to 50 minutes.
Where does the study take place?
The study visits are held in Brighton and Worthing, England.
Can I stop participating if I don't like it?
Yes, you can stop a session or leave the study at any time, for any reason, if you wish.
How to find out more
Tony Steffert
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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