* Tinnitus affects one in seven adults long-term * Once present persistently for 4 weeks, tinnitus does not usually disappear * People generally become less aware of, and less affected by, their tinnitus over time * Only one in six people with tinnitus suffers a long-term negative impact on their life * Current treatments can help to reduce the impact of tinnitus, but not silence the sound * Treatments have only so far been tested once tinnitus has been present longer than 6 months * In this study, the researchers are testing whether combining two interventions, in the early stages of tinnitus, is more effective in quieting tinnitus than using one treatment alone in the later stages of tinnitus * One intervention (acoustic ripples) involves playing sounds through headphones for up to 60 minutes per day, and is mostly done in your own time * The other intervention (transcranial direct current stimulation: tDCS) involves applying a weak electrical current to the volunteer's scalp using sponges soaked in salt water. This is performed in Newcastle University Medical School for a total of 8 sessions of 40 minutes each, spread over 4 weeks * Half the volunteers will receive the 'real' intervention, and half a 'sham' or 'placebo' version. This will be randomly determined, and the volunteers or the research team will not known which you are receiving until the end of the study * When the study ends, all volunteers will be able to use the 'real' intervention sounds in their own time, for as long as they wish, if they want to do so. No volunteers will be able to receive tDCS after the end of the study. * All volunteers also complete questionnaires about their tinnitus, related symptoms and general health, and have hearing tests plus EEG (electrical brainwave) recordings * The study is very low-risk, but does involve a total of 10 visits of around an hour each to Newcastle University Medical School over around a month. These can be arranged flexibly, including daytimes, evenings and weekends * The researchers will pay all reasonable travel expenses, and £10 per hour for the volunteer's time in participating * The study only completely ends 6 months after the date the tinnitus first started. At this point, the researchers will send some questionnaires to complete only. There is nothing to do for the study in between the tenth visit and this six-month questionnaire.
The presence of tinnitus (persistent sound heard in one or both ears that is not coming from an external sound source or actual sounds being generated inside your body such as turbulent blood flow), which has persisted for at least 3 days, and began within the last 8 weeks. You do not need to be aware of the tinnitus all the time, but it must be persistent in the sense that is can always hear it if you listen out for it, and there is not enough other sounds around to mask it.
Age 18 or over
The ability to make and communicate an informed choice about whether to take part in the study
The ability to sit still and comfortably in a comfortable chair for around 1 hour at a time.
Tinnitus due to a physical sound source in the body, such as turbulent blood flow or muscle contractions in the middle ear.
Presence of tinnitus over a period of 8 weeks
Severe or profound hearing loss at high frequencies in the tinnitus ear(s), such that you could not properly hear the sounds used in the study
Any implanted electronic device, such as a pacemaker, cochlear implant, bone-anchored hearing aid, nerve stimulator, deep brain stimulator or spinal cord stimulator
Single group
tDCS
Devicewould provide direct current for 40 minutes in 20 minute interval at 2 mA
sound therapy
Devicewould provide acoustic ripples along with tDCS
Numerical Rating Scale
Primary outcome will be perceived tinnitus loudness assessed using a self-reported Numerical Rating Scale (NRS), where participants rate the loudness of their tinnitus on a scale from 0 to 10. Higher scores indicate greater perceived loudness. The NRS will be administered at baseline and post-intervention to evaluate changes in subjective tinnitus loudness.
Tinnitus Distress using Tinnitus Handicap Inventory
Tinnitus-related distress will be assessed using the Tinnitus Handicap Inventory (THI), a 25-item self-report questionnaire measuring the emotional, functional, and catastrophic impact of tinnitus. Higher scores indicate greater perceived handicap. The THI will be administered at baseline and post-intervention to evaluate changes in tinnitus-related distress.
Tinnitus distress using Tinnitus Functional Index
Tinnitus-related functional impact will be measured using the Tinnitus Functional Index (TFI), a validated 25-item questionnaire assessing tinnitus severity across eight subscales including sleep, emotional distress, and concentration. Higher scores reflect greater tinnitus-related burden. The TFI will be completed at baseline and post-intervention to assess changes in tinnitus-related impact.
Changes in tinnitus loudness
In addition to self-reported tinnitus distress, tinnitus loudness will be assessed using audiometric loudness matching, where participants adjust the intensity of a pure tone or narrowband noise presented to the ear ipsilateral to the tinnitus until it matches the perceived loudness of their tinnitus. The matched level will be recorded in decibels sensation level (dB SL), with measurements taken at baseline and post-intervention to evaluate changes in perceived loudness.
Changes in source localized power and resting state functional connectivity
Exploratory measures will comprise resting-state electroencephalography (EEG) before and after the course of treatment, which will be analysed exploratively in terms of source-localised power and connectivity to indicate predictors of treatment success, correlates of treatment, and correlates of treatment success. 64-channel resting-state EEG data will be preprocessed in EEGlab, and transformed into source-level power and connectivity using the sLORETA toolbox. The following comparisons will be made using two-samples T tests or linear regression analyses with multiple comparisons correction:
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Newcastle University
Lead sponsor
American Tinnitus Association
Collaborator
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