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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Tinnitus, Subjective, Tinnitus, Chronic Tinnitus

In brief

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.

Key facts

Study ID

NCT07393880

Run by

University of Dublin, Trinity College

People needed

100

Starts

2026-01-30

Expected to finish

2029-01-30

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Trinity College Institute of Neuroscience (TCIN) — Dublin, Dublin, Ireland (enrolling)

Full record on ClinicalTrials.gov

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