[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623226":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":37,"centralContacts":55,"locations":64,"responsibleParty":83,"collaborators":37,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":37,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":109,"overallStatus":67,"whyStopped":37,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"University of Dublin, Trinity College","OTHER",[8,15,21,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Real Stimulation + Active Listening (ADT)","EXPERIMENTAL","Real stimulation delivered during active auditory frequency discrimination training.",[13,14],"Device: Real NITESGON","Behavioral: Active Listening",{"label":16,"type":17,"description":18,"interventionNames":19},"Real Stimulation + Passive Listening","ACTIVE_COMPARATOR","Real stimulation delivered while participants perform a visual distractor task and are instructed to ignore auditory stimuli.",[13,20],"Behavioral: Passive Listening (Control)",{"label":22,"type":23,"description":24,"interventionNames":25},"Sham Stimulation + Active Listening (ADT)","SHAM_COMPARATOR","Sham stimulation delivered during active auditory frequency discrimination training.",[26,14],"Device: Sham NITESGON",{"label":28,"type":23,"description":29,"interventionNames":30},"Sham Stimulation + Passive Listening","Sham stimulation delivered while participants perform a visual distractor task and are instructed to ignore auditory stimuli.",[26,20],[32,38,42,49],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DEVICE","Real NITESGON","Real NITESGON is delivered transcutaneously via two saline-soaked sponge electrodes (35 cm² each) positioned bilaterally over the C2 dermatomes to target the greater occipital nerve. Stimulation consists of a 20 Hz sinusoidal current at 1.5 mA peak-to-peak, ramped up over 30 seconds and ramped down over 5 seconds. It is administered concurrently with the task for \\~45 minutes per session, across eight sessions (2\u002Fweek) over 4 weeks.",[9,16],null,{"type":33,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"Sham NITESGON","Sham NITESGON is delivered using two saline-soaked sponge electrodes (35 cm² each) positioned bilaterally over the C2 dermatomes. The sham condition mimics real stimulation sensations via a 30-second ramp-up followed by a brief ramp-down, with no sustained current thereafter. Sham is administered concurrently with the task for \\~45 minutes per session, across eight sessions (2\u002Fweek) over 4 weeks.",[22,28],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"BEHAVIORAL","Active Listening","ADT is delivered using a three-interval, three-alternative forced-choice (3I-3AFC) frequency discrimination task. Standard tone frequencies are individually selected using ERB\u002Fcritical-band spacing, centered one octave below each participant's dominant tinnitus pitch and extending to lower frequencies; the highest standard is kept below the tinnitus pitch region. Tones are presented binaurally via headphones, with presentation levels calibrated to individual audiometric thresholds and matched for equal SPL in both ears.",[9,22],[48],"Auditory frequency discrimination training (ADT)",{"type":43,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Passive Listening (Control)","VisDT uses a three-interval, three-alternative forced-choice (3I-3AFC) paradigm with Gabor patches (sinusoidal gratings windowed by a Gaussian envelope) of fixed spatial frequency (6 cycles\u002Fdegree) and fixed spatial spread; on each trial, one interval contains an orientation deviant relative to the standard. During VisDT, participants attend to the visual task while concurrent binaural tones are presented passively using a predetermined, non-adaptive schedule. Auditory tones are individually calibrated to audiometric thresholds and drawn from ERB-spaced frequencies centered one octave below the dominant tinnitus pitch and extending to lower frequencies, with the highest frequency kept below the tinnitus pitch region.",[16,28],[54],"Visual distractor task (VisDT)",[56,61],{"name":57,"role":58,"phone":59,"phoneExt":37,"email":60},"Sven Vanneste, PhD","CONTACT","+353 87 470 2835.","sven.vanneste@tcd.ie",{"name":62,"role":58,"phone":37,"phoneExt":37,"email":63},"Anusha Mohan, PhD","anusha.mohan@tcd.ie",[65],{"facility":66,"status":67,"city":68,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Trinity College Institute of Neuroscience (TCIN)","RECRUITING","Dublin","D02","Ireland","IE",{"type":73,"coordinates":74},"Point",[75,76],-6.24889,53.33306,{"lat":76,"lon":75},[79],{"name":80,"role":58,"phone":81,"phoneExt":37,"email":82},"Fabian Broecker","+353 087 470 2835.","broeckef@tcd.ie",{"type":84,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"PRINCIPAL_INVESTIGATOR","Sven Vanneste","Professor","100623226","bimodal-electrical-sound-stimulation-and-auditory-training-for-chronic-tonal-tinnitus-100623226",false,"NCT07393880","Bimodal Electrical-Sound Stimulation and Auditory Training for Chronic Tonal Tinnitus","Non-Invasively Re-Training the Tinnitus Brain Using Bimodal Electrical-Sound Stimulation (NITESGON-ADT): Protocol for a Prospective, Double-Blind, Randomised Controlled Trial","NITESGON-ADT","Inclusion Criteria:\n\n* Adults aged 18-80 years\n* Continuous subjective tinnitus for \\>3 months and ≤5 years\n* Predominantly tonal tinnitus (unilateral or bilateral)\n* Screening THI score 28-76\n* Minimum Masking Level (MML) 20-80 dB HL\n* No prior tinnitus neuromodulation treatment\n* Able to comply with eight sessions over four weeks and follow-up assessments\n\nExclusion Criteria:\n\n* Objective tinnitus or predominantly somatic tinnitus\n* Pulsatile tinnitus\n* Evidence of conductive hearing loss (abnormal otoscopy or tympanometry)\n* 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\n* Hearing aid use initiated within the past 90 days\n* Active implantable medical device (e.g., pacemaker, DBS, cochlear implant)\n* LDL \\\u003C30 dB SL at 500 Hz in either ear\n* Diagnosis of temporomandibular joint disorder or occipital neuralgia\n* Severe anxiety (STAI \\>120\u002F160)\n* Cognitive impairment (MMSE \\\u003C25)\n* Severe depressive symptoms (BDI ≥30)\n* Diagnosis of Menière's disease\n* Current pregnancy\n* Involvement in medicolegal cases\n* History of auditory hallucinations\n* Current prescription of central nervous system drugs likely to alter neuromodulatory function (e.g., noradrenergic, dopaminergic, serotonergic, benzodiazepine, cholinergic, or other psychoactive medications)\n* Currently enrolled in another interventional study","ALL","18 Years","80 Years",{"count":99,"type":100},100,"ESTIMATED","INTERVENTIONAL",[103],"NA","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.",[106,107,108],"Tinnitus, Subjective","Tinnitus","Chronic Tinnitus",[107],"2026-04-02",{"date":112,"type":113},"2026-04-03","ACTUAL",{"date":115,"type":113},"2026-01-30",{"date":117,"type":100},"2029-01-30",{"name":5,"class":6},1]