Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07393880

Bimodal Electrical-Sound Stimulation and Auditory Training for Chronic Tonal Tinnitus

Led by University of Dublin, Trinity College · Updated on 2026-04-03

100

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study tests whether pairing non-invasive stimulation of the greater occipital nerve (NITESGON) with an attentionally demanding auditory frequency discrimination training task reduces tinnitus loudness and tinnitus-related distress. One hundred adults with chronic tonal tinnitus will be randomised to one of four groups in a 2×2 factorial design: real versus sham NITESGON and active versus passive listening during auditory stimulation. Participants complete eight sessions across four weeks, with outcomes assessed at baseline, end of treatment, 28 days post-treatment, and 6 months post-treatment.

CONDITIONS

Official Title

Bimodal Electrical-Sound Stimulation and Auditory Training for Chronic Tonal Tinnitus

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18-80 years
  • Continuous subjective tinnitus lasting more than 3 months and up to 5 years
  • Predominantly tonal tinnitus in one or both ears
  • Screening Tinnitus Handicap Inventory score between 28 and 76
  • Minimum Masking Level between 20 and 80 dB HL
  • No prior neuromodulation treatment for tinnitus
  • Ability to attend eight sessions over four weeks and complete follow-up assessments
Not Eligible

You will not qualify if you...

  • Objective or predominantly somatic tinnitus
  • Pulsatile tinnitus
  • Conductive hearing loss shown by abnormal ear examination or tympanometry
  • Hearing loss greater than 40 dB HL at any frequency between 250 Hz and 1 kHz or greater than 80 dB HL at any frequency between 2 kHz and 8 kHz in either ear
  • Hearing aid use started within the past 90 days
  • Presence of active implantable medical devices such as pacemakers, deep brain stimulators, or cochlear implants
  • Loudness Discomfort Level less than 30 dB SL at 500 Hz in either ear
  • Diagnosis of temporomandibular joint disorder or occipital neuralgia
  • Severe anxiety with State-Trait Anxiety Inventory score over 120
  • Cognitive impairment with Mini-Mental State Examination score below 25
  • Severe depressive symptoms with Beck Depression Inventory score of 30 or higher
  • Diagnosis of Menière's disease
  • Current pregnancy
  • Involvement in medicolegal cases
  • History of auditory hallucinations
  • Current use of central nervous system drugs that affect neuromodulation
  • Participation in another interventional study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Trinity College Institute of Neuroscience (TCIN)

Dublin, Dublin, Ireland, D02

Actively Recruiting

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Research Team

S

Sven Vanneste, PhD

CONTACT

A

Anusha Mohan, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

4

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Bimodal Electrical-Sound Stimulation and Auditory Training for Chronic Tonal Tinnitus | DecenTrialz