In the UK, approximately one in eight people experience tinnitus. NHS audiology departments are the main provider for services for people with tinnitus and hearing loss.
Why do we need a clinical trial?
In the UK the most common management strategy for tinnitus is education and support and some form of sound therapy. Treatment is however variable between clinics.
While all clinics tend to provide education and support, the additional management strategies (i.e. provision of devices) depends very much on individual clinical decisions. There is no rigorous research evidence for the benefits of hearing aids beyond education and support for people with tinnitus and hearing loss. There is no standard way to treat patients and the decision to fit hearing aids is left to individual audiologists.
Although hearing aids are prescribed primarily to overcome hearing loss, they may also be effective for tinnitus. Hearing aids can amplify environmental sounds and mask or provide distraction from tinnitus. They can reduce listening effort and improve communication which can reduce stress and anxiety, commonly associated with tinnitus. Other possible mechanisms include preventing changes in the brain related to hearing loss.
High-quality evidence is needed in order to decide whether patients should always be offered hearing aids. This can be done in a clinical trial that by comparing:
- Education and support (the usual treatment)
- Education and support with hearing aids.
This trial would need to be large and therefore some investigations are needed to find out whether it would be possible to run. This can be checked by running a smaller study, known as a ‘feasibility study’. The National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre are working alongside the Nottingham Clinical Trials Unit and the British Tinnitus Association (BTA) to conduct a feasibility study to check:
- if clinicians and patients are willing to take part in a trial,
- what outcome measures are relevant for patients, and
- what a large trial should look like.
The study is being funded by the NIHR Research for Patient Benefit programme.
Who can take part in the HUSH feasibility trial?
The HUSH feasibility trial will be looking to recruit adults with tinnitus and hearing loss who have been referred to an audiology clinic for their tinnitus. Five UK audiology departments will take part. We aim to recruit 100 participants.
What does taking part involve?
All patients who agree to take part in the trial will be given standard care, including explanations of tinnitus and its association with hearing loss, education about lifestyle factors that may have positive and negative effects on tinnitus and explanation of available management strategies and counselling depending on patient need. In addition to standard care, half of the patients who join the trial will be given hearing aids.
What are the timelines of the trial?
It is hoped that the trial will begin recruiting in October 2018 and it is anticipated that it will take 12 months to recruit the required 100 participants.
Patient involvement in the development of the HUSH trial
The importance of patient-focused research is becoming increasingly recognised throughout the field of clinical research. What this means is that patients are becoming more involved not only by enrolling as a participant in a clinical trial, but also by assisting in all aspects of trial delivery. This includes selecting a suitable treatment to be tested, inputting into how the treatment should be tested and what it should involve for patients, and perhaps most importantly, what outcomes are most important to patients.
The research question has been voted as one of the top ten tinnitus priorities by clinicians and patients in a James Lind Alliance (JLA) Tinnitus Priority Setting Partnership. The design of the trial was discussed with people with tinnitus to make sure the trial design was acceptable and the amount of engagement from participants was appropriate and manageable (number of visits to the clinic, number and content of questionnaires to complete, length of time in the trial).
The HUSH trial has been designed and developed alongside the British Tinnitus Association and a patient representative who has been suffering with tinnitus for over 20 years. This support has proved invaluable and has helped to ensure that the needs of tinnitus patients are at the heart of the trial plan.
How can I help?
The HUSH trial is looking for adults with tinnitus and hearing loss who have been referred to an audiology clinic for their tinnitus. Recruitment of participants will be done by audiologists at the participating audiology clinics, therefore the BTA or NIHR Nottingham Biomedical Research Centre are not able to enrol potentially interested people on this trial, however there is still a great deal you can do to help. By simply raising the awareness of the trial within your community you will be making a huge contribution to the success of the HUSH trial, and helping us in making the next big step towards guiding the treatment of tinnitus in the future.
This project was funded by the NIHR RfPB programme, project reference PB-PG-0816-20014.
The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.
Updated 3 July 2019
