NCT07393880 Bimodal Electrical-Sound Stimulation and Auditory Training for Chronic Tonal Tinnitus
| NCT ID | NCT07393880 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Dublin, Trinity College |
| Condition | Tinnitus, Subjective |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-01-30 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-01-30 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07393880 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Tinnitus, Subjective. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07393880 currently recruiting?
Yes, NCT07393880 is actively recruiting participants. Contact the research team at sven.vanneste@tcd.ie for enrollment information.
Where is the NCT07393880 trial being conducted?
This trial is being conducted at Dublin, Ireland.
Who is sponsoring the NCT07393880 clinical trial?
NCT07393880 is sponsored by University of Dublin, Trinity College. The trial plans to enroll 100 participants.