In This Study, we 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

Summary

* 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.

Conditions

• Tinnitus
• Acute

Interventions

DEVICE

tDCS

would provide direct current for 40 minutes in 20 minute interval at 2 mA

DEVICE

sound therapy

would provide acoustic ripples along with tDCS

Sponsors & Collaborators

• American Tinnitus Association

  collaborator OTHER

• Newcastle University

  lead OTHER

Principal Investigators

• William Sedley, PhD · Newcastle University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-05

Primary Completion

2026-12-31

Completion

2027-03-09