Tinnitus, SubjectiveNITESGON-ADTNCT07393880
Bimodal Electrical-Sound Stimulation and Auditory Training for Chronic Tonal Tinnitus
A study testing Real NITESGON and Active Listening in people with Tinnitus, Subjective and Tinnitus, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tinnitus, Subjective, Tinnitus, Chronic Tinnitus
- What is being tested?
- Real NITESGON and Active Listening
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 30 Jan 2026to 30 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anusha Mohan, PhD contact
Ireland1 site, 1 recruiting
- Recruiting
Trinity College Institute of Neuroscience (TCIN)
Dublin, Dublin, D02
Fabian Broecker, +353 087 470 2835., broeckef@tcd.ie
About this study
Official title: Non-Invasively Re-Training the Tinnitus Brain Using Bimodal Electrical-Sound Stimulation (NITESGON-ADT): Protocol for a Prospective, Double-Blind, Randomised Controlled Trial
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.
Read the detailed description
This is a single-centre, prospective, double-blind, placebo-controlled, 2×2 factorial randomised controlled trial conducted at Trinity College Dublin. The intervention combines transcutaneous electrical stimulation targeting the greater occipital nerve (NITESGON) with auditory stimulation delivered during a structured training paradigm. The two between-subjects factors are stimulation condition (real NITESGON vs sham NITESGON) and listening condition (active listening: auditory frequency discrimination training vs passive listening: visual distractor task while auditory stimuli are presented). One hundred adults with chronic tonal tinnitus will be randomised 1:1:1:1 to one of four arms. Participants complete eight sessions (two per week for four weeks). Primary outcomes-tinnitus loudness (VAS 0-100), tinnitus-related functional impact (TFI 0-100), and tinnitus handicap (THI 0-100)-and secondary outcomes are assessed at baseline (T0), end of treatment (T1), 28 days after treatment completion (T2), and 6 months after treatment completion (T3). Secondary outcomes include tinnitus psychoacoustics, extended high-frequency audiometry, speech-in-noise performance, EEG (resting-state and auditory oddball), autonomic/biomarker measures (pupillometry, heart rate, saliva), patient global impression of change, quality of life, and safety/blinding assessments.
- Conditions
- Tinnitus, Subjective, Tinnitus, Chronic Tinnitus
- Being tested
- Real NITESGON, Sham NITESGON, Active Listening, Passive Listening (Control)
- Keywords
- Tinnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real NITESGONDevice
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/week) over 4 weeks.
Sham NITESGONDevice
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/week) over 4 weeks.
Active ListeningBehavioural
Also called Auditory frequency discrimination training (ADT)
ADT is delivered using a three-interval, three-alternative forced-choice (3I-3AFC) frequency discrimination task. Standard tone frequencies are individually selected using ERB/critical-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.
Passive Listening (Control)Behavioural
Also called Visual distractor task (VisDT)
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/degree) 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.
| Study group | Role | What they receive |
|---|---|---|
| Real Stimulation + Active Listening (ADT) | Experimental | Real stimulation delivered during active auditory frequency discrimination training. Receives: Device: Real NITESGON; Behavioral: Active Listening |
| Real Stimulation + Passive Listening | Active comparator | Real stimulation delivered while participants perform a visual distractor task and are instructed to ignore auditory stimuli. Receives: Device: Real NITESGON; Behavioral: Passive Listening (Control) |
| Sham Stimulation + Active Listening (ADT) | Sham comparator | Sham stimulation delivered during active auditory frequency discrimination training. Receives: Device: Sham NITESGON; Behavioral: Active Listening |
| Sham Stimulation + Passive Listening | Sham comparator | Sham stimulation delivered while participants perform a visual distractor task and are instructed to ignore auditory stimuli. Receives: Device: Sham NITESGON; Behavioral: Passive Listening (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Loudness (Visual Analogue Scale, VAS 0-100)
0-100 mm VAS anchored from "not audible" to "extremely loud"; higher scores indicate greater perceived tinnitus loudness.
Measured: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.
Tinnitus Functional Index (TFI, 0-100)
25-item self-report measure of tinnitus-related functional impact; total score 0-100, higher scores indicate greater impairment.
Measured: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.
Tinnitus Handicap Inventory (THI, 0-100)
25-item measure of tinnitus-related handicap; total score 0-100, higher scores indicate greater handicap.
Measured: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.
Secondary outcomes (15)
Audiometry (Extended High-Frequency Thresholds up to 13 kHz)
Air-conduction pure-tone audiometry thresholds will be measured from 250 Hz up to 13 kHz (extended high-frequency audiometry) to characterise hearing status and support calibration of stimulus sensation levels.
Measured: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.
Speech-in-Noise Performance (e.g., QuickSIN)
Speech perception in noise will be assessed using a standardised speech-in-noise test administered in a controlled environment.
Measured: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.
Patient Global Impression of Change (PGIC)
Participant-rated global change since baseline using the Patient Global Impression of Change (PGIC) scale (-3 = very much worse to +3 = very much improved; higher scores indicate greater improvement).
Measured: End of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.
Quality of Life (World Health Organization Quality of Life-BREF questionnaire)
Quality of life assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF), yielding domain scores and an overall score (0-100; higher scores indicate better quality of life).
Measured: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.
Adverse Events (Stimulation Side-Effects Questionnaire)
Stimulation tolerability assessed each visit using a Stimulation Side-Effects Questionnaire recording presence and severity of side effects (e.g., tingling, itching, headache) rated on a numeric severity scale (0-10; higher scores indicate worse side effects), plus event frequency.
Measured: Up to 4 weeks (Sessions 1-8)
Tinnitus Pitch Matching
Dominant tinnitus pitch estimated by psychoacoustic pitch matching and recorded as frequency in hertz (Hz).
Measured: Baseline, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.
Tinnitus Loudness Matching and Discomfort Levels
Loudness matching and discomfort levels: Tinnitus loudness matching recorded in decibels sensation level (dB SL; dB above audiometric threshold) at the matched frequency, and loudness discomfort levels recorded in decibels sensation level (dB SL; dB above threshold) at tested frequencies.
Measured: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.
Minimum Masking Level (MML)
Broadband noise level required to fully mask tinnitus, recorded in decibels hearing level (dB HL).
Measured: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.
Resting-State EEG Spectral Power (Eyes Closed)
Resting-state eyes-closed electroencephalography (EEG) spectral power averaged within prespecified frequency bands and electrode/network regions, reported in decibels (dB); higher values indicate greater spectral power.
Measured: Baseline visit, end of treatment (4 weeks), 28 days post-treatment, and 6 months post-treatment.
Resting-State EEG Functional Connectivity (Eyes Closed)
Resting-state eyes-closed EEG functional connectivity within prespecified networks, quantified as phase-locking value (PLV; unitless, 0-1); higher values indicate stronger phase synchronization.
Measured: Baseline visit, end of treatment (4 weeks), 28 days post-treatment, and 6 months post-treatment.
Auditory Oddball Task-Evoked Response Amplitude
Auditory oddball event-related potential (ERP) amplitude (e.g., P300) averaged over prespecified electrodes/time windows, reported in microvolts (µV); higher absolute amplitude indicates larger task-evoked response.
Measured: Baseline visit, end of treatment (4 weeks), 28 days post-treatment, and 6 months post-treatment.
Auditory Oddball Task-Evoked Response Latency
Auditory oddball ERP component latency (e.g., P300 peak latency) within prespecified time windows, reported in milliseconds (ms); lower values indicate faster evoked responses.
Measured: Baseline visit, end of treatment (4 weeks), 28 days post-treatment, and 6 months post-treatment.
Pupillometry
Task-related pupil diameter during pupillometry, summarized as mean (or peak) pupil size change from baseline, reported in millimeters (mm); larger values indicate greater pupil dilation.
Measured: Baseline visit, end of treatment (4 weeks), 28 days post-treatment, and 6 months post-treatment.
Heart Rate
Electrocardiography (ECG)-derived heart rate, reported in beats per minute (bpm); higher values indicate faster heart rate.
Measured: Baseline visit, end of treatment (4 weeks), 28 days post-treatment, and 6 months post-treatment.
Saliva Biomarkers
Concentration of prespecified salivary biomarkers of arousal/neuromodulatory engagement, reported in nanograms per milliliter (ng/mL) (or assay-specific units); higher values indicate higher biomarker concentration.
Measured: Baseline visit, end of treatment (4 weeks), 28 days post-treatment, and 6 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start30 Jan 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2×2 factorial randomised controlled trial with two between-subjects factors: stimulation condition (real vs sham NITESGON) and listening condition (active auditory discrimination training vs passive listening during a visual task). Participants are assigned 1:1:1:1 to four parallel arms.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sven Vanneste, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393880
- Sponsor's protocol ID
- NITESGON-SPREC102020-46
- Other IDs
- DRG2332
- Acronym
- NITESGON-ADT
- Status last verified
- Apr 2026
- First submitted
- 23 Jan 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasively Re-Training the Tinnitus Brain Using Bimodal Electrical-Sound Stimulation (NITESGON-ADT): Protocol for a Prospective, Double-Blind, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07393880
- Acronym / sponsor ID
- NITESGON-ADT / NITESGON-SPREC102020-46
- Conditions
- Tinnitus, Subjective, Tinnitus, Chronic Tinnitus
- Keywords
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Jan 2029 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-centre, prospective, double-blind, placebo-controlled, 2×2 factorial randomised controlled trial conducted at Trinity College Dublin. The intervention combines transcutaneous electrical stimulation targeting the greater occipital nerve (NITESGON) with auditory stimulation delivered during a structured training paradigm. The two between-subjects factors are stimulation condition (real NITESGON vs sham NITESGON) and listening condition (active listening: auditory frequency discrimination training vs passive listening: visual distractor task while auditory stimuli are presented). One hundred adults with chronic tonal tinnitus will be randomised 1:1:1:1 to one of four arms. Participants complete eight sessions (two per week for four weeks). Primary outcomes-tinnitus loudness (VAS 0-100), tinnitus-related functional impact (TFI 0-100), and tinnitus handicap (THI 0-100)-and secondary outcomes are assessed at baseline (T0), end of treatment (T1), 28 days after treatment completion (T2), and 6 months after treatment completion (T3). Secondary outcomes include tinnitus psychoacoustics, extended high-frequency audiometry, speech-in-noise performance, EEG (resting-state and auditory oddball), autonomic/biomarker measures (pupillometry, heart rate, saliva), patient global impression of change, quality of life, and safety/blinding assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- 2×2 factorial randomised controlled trial with two between-subjects factors: stimulation condition (real vs sham NITESGON) and listening condition (active auditory discrimination training vs passive listening during a visual task). Participants are assigned 1:1:1:1 to four parallel arms.
| Arm | Type | Receives |
|---|---|---|
| Real Stimulation + Active Listening (ADT) | Experimental | Device: Real NITESGON, Behavioral: Active ListeningReal stimulation delivered during active auditory frequency discrimination training. |
| Real Stimulation + Passive Listening | Active comparator | Device: Real NITESGON, Behavioral: Passive Listening (Control)Real stimulation delivered while participants perform a visual distractor task and are instructed to ignore auditory stimuli. |
| Sham Stimulation + Active Listening (ADT) | Sham comparator | Device: Sham NITESGON, Behavioral: Active ListeningSham stimulation delivered during active auditory frequency discrimination training. |
| Sham Stimulation + Passive Listening | Sham comparator | Device: Sham NITESGON, Behavioral: Passive Listening (Control)Sham stimulation delivered while participants perform a visual distractor task and are instructed to ignore auditory stimuli. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real NITESGONReal 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/week) over 4 weeks. | Device | Real Stimulation + Active Listening (ADT), Real Stimulation + Passive Listening |
| Sham NITESGONSham 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/week) over 4 weeks. | Device | Sham Stimulation + Active Listening (ADT), Sham Stimulation + Passive Listening |
| Active ListeningAlso: Auditory frequency discrimination training (ADT)ADT is delivered using a three-interval, three-alternative forced-choice (3I-3AFC) frequency discrimination task. Standard tone frequencies are individually selected using ERB/critical-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. | Behavioural | Real Stimulation + Active Listening (ADT), Sham Stimulation + Active Listening (ADT) |
| Passive Listening (Control)Also: Visual distractor task (VisDT)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/degree) 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. | Behavioural | Real Stimulation + Passive Listening, Sham Stimulation + Passive Listening |
Primary outcome
Tinnitus Loudness (Visual Analogue Scale, VAS 0-100)
Time frame: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.
0-100 mm VAS anchored from "not audible" to "extremely loud"; higher scores indicate greater perceived tinnitus loudness.
Tinnitus Functional Index (TFI, 0-100)
Time frame: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.
25-item self-report measure of tinnitus-related functional impact; total score 0-100, higher scores indicate greater impairment.
Tinnitus Handicap Inventory (THI, 0-100)
Time frame: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.
25-item measure of tinnitus-related handicap; total score 0-100, higher scores indicate greater handicap.
15 secondary outcomes
Audiometry (Extended High-Frequency Thresholds up to 13 kHz)
Time frame: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.
Speech-in-Noise Performance (e.g., QuickSIN)
Time frame: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.
Patient Global Impression of Change (PGIC)
Time frame: End of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.
Quality of Life (World Health Organization Quality of Life-BREF questionnaire)
Time frame: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.
Adverse Events (Stimulation Side-Effects Questionnaire)
Time frame: Up to 4 weeks (Sessions 1-8)
Tinnitus Pitch Matching
Time frame: Baseline, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.
Tinnitus Loudness Matching and Discomfort Levels
Time frame: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.
Minimum Masking Level (MML)
Time frame: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.
Resting-State EEG Spectral Power (Eyes Closed)
Time frame: Baseline visit, end of treatment (4 weeks), 28 days post-treatment, and 6 months post-treatment.
Resting-State EEG Functional Connectivity (Eyes Closed)
Time frame: Baseline visit, end of treatment (4 weeks), 28 days post-treatment, and 6 months post-treatment.
Auditory Oddball Task-Evoked Response Amplitude
Time frame: Baseline visit, end of treatment (4 weeks), 28 days post-treatment, and 6 months post-treatment.
Auditory Oddball Task-Evoked Response Latency
Time frame: Baseline visit, end of treatment (4 weeks), 28 days post-treatment, and 6 months post-treatment.
Pupillometry
Time frame: Baseline visit, end of treatment (4 weeks), 28 days post-treatment, and 6 months post-treatment.
Heart Rate
Time frame: Baseline visit, end of treatment (4 weeks), 28 days post-treatment, and 6 months post-treatment.
Saliva Biomarkers
Time frame: Baseline visit, end of treatment (4 weeks), 28 days post-treatment, and 6 months post-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Undecided
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COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY
Somatosensory Tinnitus, Subjektif tınnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anusha Mohan, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real NITESGON and Active Listening in people with Tinnitus, Subjective and Tinnitus, run by University of Dublin, Trinity College at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sven Vanneste, PhD (+353 87 470 2835., sven.vanneste@tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Loudness (Visual Analogue Scale, VAS 0-100) (time frame: Baseline visit, end of treatment at 4 weeks, 28 days post-treatment, and 6 months post-treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.