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Search / Trial NCT07128004

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

Launched by NEWCASTLE UNIVERSITY · Aug 13, 2025

Trial Information

Current as of August 20, 2025

Not yet recruiting

Keywords

Acute Tinnitus Treatment Sound Therapy T Dcs

ClinConnect Summary

This study is looking at whether using two different treatments together early on can help reduce the sound of tinnitus better than using just one treatment later when tinnitus has lasted a long time. Tinnitus is when you hear ringing or buzzing sounds that aren’t caused by anything outside your body. The study focuses on people who have started hearing these sounds recently—between 3 days and 8 weeks ago. Researchers want to see if starting treatment early can quiet the tinnitus more effectively.

If you take part, you’ll be asked to come to Newcastle University Medical School about 10 times over a month. During these visits, you’ll receive one of two treatments: one involves listening to special sounds through headphones for about an hour a day at home, and the other uses a mild electrical current applied to your scalp in short sessions at the university. You won’t know if you’re getting the real treatment or a placebo, and neither will the researchers until the study ends. You’ll also complete some questionnaires about your tinnitus and health, have hearing tests, and wear a cap that records your brain’s electrical activity. The study is low-risk, and you’ll be reimbursed for travel and time. After the study, everyone can keep using the sound treatment if they want, but the electrical treatment won’t be offered anymore. This research is for adults aged 18 and over who have new, persistent tinnitus not caused by physical issues like blood flow or muscle problems, and who don’t have certain medical conditions or implanted devices.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 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
  • Any areas of broken skin on the parts of the scalp where tDCS is applied
  • Ménière's disease
  • Any abnormality of brain structure (e.g. stroke, tumour), or other neurological disorder (e.g. multiple sclerosis or epilepsy)
  • The ongoing use of sedating medications, or certain other nerve- or brain-acting medications
  • A current mental health condition of sufficient severity to prevent certain activities of everyday life
  • In addition to these criteria, the researcher might have other reasons to suspect that participation is either contraindicated, or might be unsuitable. In such cases, the researcher should discuss these concerns with the potential participant and/or a senior member of the research team. Participation should only proceed if all those involved in these discussions agree it should.
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About Newcastle University

Newcastle University is a leading research institution located in the United Kingdom, renowned for its commitment to advancing healthcare through innovative clinical trials and scientific research. The university's Clinical Trials Unit plays a pivotal role in the design, coordination, and execution of high-quality clinical studies, focusing on a wide range of therapeutic areas. With a multidisciplinary team of experts, Newcastle University fosters collaboration between academia, industry, and healthcare providers, ensuring that research findings translate into meaningful advancements in patient care. Its dedication to excellence and ethical standards positions Newcastle University as a trusted sponsor in the clinical research landscape.

Locations

Patients applied

0 patients applied

Trial Officials

William Sedley, PhD

Principal Investigator

Newcastle University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported