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New treatment option for Tinnitus, Subjective
Official title Bimodal Electrical-Sound Stimulation and Auditory Training for Chronic Tonal Tinnitus
ClinicalTrials.gov ID: NCT07393880
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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
You likely can't join 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)
See the full eligibility 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
- 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 treatment study
The study team makes the final eligibility decision.
Where it's taking place
- Dublin, Dublin, Ireland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dublin, Dublin, Ireland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.