RecruitingNot Applicable

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

Ireland100 participantsStarted 2026-01-30

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged 18-80 years * Continuous subjective tinnitus for \>3 months and ≤5 years * Predominantly tonal tinnitus (unilateral or bilateral) * Screening THI score 28-76 * Minimum Masking Level (MML) 20-80 dB HL * No prior tinnitus neuromodulation treatment * Able to comply with eight sessions over four weeks and follow-up assessments Exclusion Criteria: * Objective tinnitus or predominantly somatic tinnitus * Pulsatile tinnitus * Evidence of conductive hearing loss (abnormal otoscopy or tympanometry) * Pure-tone audiometry exclusions: \>40 dB HL at any frequency 250 Hz-1 kHz OR \>80 dB HL at any frequency 2-8 kHz in either ear * Hearing aid use initiated within the past 90 days * Active implantable medical device (e.g., pacemaker, DBS, cochlear implant) * LDL \<30 dB SL at 500 Hz in either ear * Diagnosis of temporomandibular joint disorder or occipital neuralgia * Severe anxiety (STAI \>120/160) * Cognitive impairment (MMSE \<25) * Severe depressive symptoms (BDI ≥30) * Diagnosis of Menière's disease * Current pregnancy * Involvement in medicolegal cases * History of auditory hallucinations * Current prescription of central nervous system drugs likely to alter neuromodulatory function (e.g., noradrenergic, dopaminergic, serotonergic, benzodiazepine, cholinergic, or other psychoactive medications) * Currently enrolled in another interventional study

What they're measuring

Tinnitus Loudness (Visual Analogue Scale, VAS 0-100)

Timeframe: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.

Tinnitus Functional Index (TFI, 0-100)

Timeframe: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.

Tinnitus Handicap Inventory (THI, 0-100)

Timeframe: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.

Trial details

NCT IDNCT07393880

SponsorUniversity of Dublin, Trinity College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09-30

Contact for this trial

Sven Vanneste, PhD

+353 87 470 2835. sven.vanneste@tcd.ie

View on ClinicalTrials.gov More Tinnitus, Subjective trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Tinnitus Loudness (Visual Analogue Scale, VAS 0-100)

Timeframe: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.

Tinnitus Functional Index (TFI, 0-100)

Timeframe: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.

Tinnitus Handicap Inventory (THI, 0-100)

Timeframe: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.