Efficacy of auditory-visual attentional training in adults with chronic tinnitus: A study protocol for a randomized controlled trial

Hossein Namvar Arefi; Farnoush Jarollahi; Samer Mohsen; Shohreh Jalaie

doi:10.12688/f1000research.162088.1

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Study Protocol

Efficacy of auditory-visual attentional training in adults with chronic tinnitus: A study protocol for a randomized controlled trial

[version 1; peer review: 1 approved with reservations]

Hossein Namvar Arefi¹, Farnoush Jarollahi¹, Samer Mohsen ², Shohreh Jalaie³

PUBLISHED 12 May 2025

Author details Author details

¹ Department of Audiology, Iran University of Medical Sciences, Tehran, Tehran Province, Iran
² Department of Otolaryngology, Faculty of Medicine, Damascus University, Damascus, Syria
³ School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Tehran Province, Iran

Hossein Namvar Arefi
Roles: Conceptualization, Methodology, Validation, Writing – Original Draft Preparation

Farnoush Jarollahi
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Samer Mohsen
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Shohreh Jalaie
Roles: Formal Analysis, Supervision, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

Abstract

Background

Chronic tinnitus, a phantom auditory perception affecting a significant proportion of adults worldwide, is associated with attentional deficits and maladaptive neuroplasticity. While existing rehabilitation strategies often neglect multi-sensory attentional processing, this study will evaluate a novel auditory-visual attentional training protocol designed to modulate tinnitus-related neural and cognitive dysfunction.

Methods

Forty-five adults with chronic tinnitus will be randomly assigned to visual-only attentional training, auditory-only training, or combined auditory-visual training. Participants will complete daily 30-minute sessions via a mobile platform over three weeks. Primary outcomes included tinnitus severity, measured by the Tinnitus Handicap Questionnaire (THQ), and attention performance across three domains: visual attention (Stroop test accuracy), auditory attention (Test of Attention in Listening metrics), and global attention (Attention Network Test scores). Neurophysiological assessments will comprise resting-state quantitative electroencephalography (qEEG) spectral power analysis and modality-specific evoked potentials (auditory and visual P300). Data will be analyzed using standardized low-resolution brain electromagnetic tomography (sLORETA) for neural source localization and mixed-effects models for behavioral outcomes.

Conclusion

This trial will systematically evaluate multi-sensory attentional training by integrating behavioral and neurophysiological assessments, including resting-state qEEG dynamics and modality-specific P300 responses. Findings provide insights into the interplay between attentional plasticity, neural oscillatory patterns, and tinnitus symptom modulation, informing future targeted rehabilitation strategies.

Trial registration

Iranian Registry of Clinical Trials (IRCT20220206053952N2).

Keywords

Chronic tinnitus, auditory-visual attentional training, randomized controlled trial, neuroplasticity, quantitative electroencephalography (qEEG), P300 evoked potentials, cognitive rehabilitation, multi-sensory integration

Corresponding author: Samer Mohsen

Competing interests: No competing interests were disclosed.

Grant information: This work is a part of the doctoral thesis in the Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, under the grant number 1400-3-6-22348.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2025 Namvar Arefi H et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Namvar Arefi H, Jarollahi F, Mohsen S and Jalaie S. Efficacy of auditory-visual attentional training in adults with chronic tinnitus: A study protocol for a randomized controlled trial [version 1; peer review: 1 approved with reservations]. F1000Research 2025, 14:488 (https://doi.org/10.12688/f1000research.162088.1) First published: 12 May 2025, 14:488 (https://doi.org/10.12688/f1000research.162088.1) Latest published: 12 May 2025, 14:488 (https://doi.org/10.12688/f1000research.162088.1)

Introduction

Chronic tinnitus, the persistent perception of sound in the absence of an external auditory stimulus, affects approximately 10–26% of adults globally, with 2–3% experiencing severe impairment in daily functioning, including sleep disturbances, emotional distress, and cognitive deficits.^1,2 Emerging evidence implicates dysfunctional attentional networks and maladaptive neuroplasticity within auditory-limbic pathways as key contributors to tinnitus chronicity. For instance, maladaptive plasticity in the central auditory system—such as increased spontaneous neuronal firing and synchrony—has been linked to persistent phantom perceptions, even in cases without measurable hearing loss.^3,4 Additionally, attentional biases toward tinnitus-related stimuli amplify distress through feedback loops involving the prefrontal cortex and limbic structures, as proposed in the Neurofunctional Tinnitus Model (NfTM).⁵

Current interventions, such as cognitive-behavioral therapy (CBT) and sound masking, primarily target symptom management rather than the underlying neural mechanisms. While CBT reduces emotional reactivity to tinnitus, it does not address the maladaptive neuroplasticity driving the percept itself.⁶ Similarly, Jastreboff’s Tinnitus Retraining Therapy (TRT), which combines counseling and sound therapy, focuses on habituation but lacks structured cognitive training to recalibrate attentional networks.^7,8 Neurophysiological models, including Jastreboff’s limbic-auditory hypothesis, posit that tinnitus distress arises from aberrant interactions between the auditory cortex, limbic system (e.g., amygdala, anterior cingulate cortex), and attention networks.^3,7 These interactions are further modulated by evaluative conditional learning, where neutral tinnitus signals acquire negative emotional valence through repeated pairing with stress or anxiety.⁵

This protocol introduces a novel auditory-visual attentional training (AVAT) program, which is grounded in Posner’s attention model—comprising alerting, orienting, and executive control—and informed by principles of cross-modal plasticity.^9–11 The phenomenon of cross-modal plasticity, as exemplified by the McGurk effect—where visual cues alter auditory perception—and by evidence that visual inputs modulate neuronal activity in the auditory cortex,¹² underscores the brain’s remarkable capacity to rewire sensory networks. AVAT leverages this capacity by integrating visual and auditory stimuli to redirect attention away from tinnitus. Specifically, the program is designed to recalibrate dysfunctional neural networks by promoting inhibitory interactions between the auditory and visual cortices, thereby reducing hyperactivity in tinnitus-related regions.¹³ Additionally, by employing dual-modality tasks—for example, requiring participants to respond to target auditory tones while ignoring conflicting visual cues—AVAT aims to reduce attentional biases that contribute to the preferential allocation of attention to tinnitus.⁵ Repeated exposure to non-threatening multisensory stimuli is also expected to mitigate symptom severity by weakening the emotional salience of tinnitus.^3,5

This trial will address three critical challenges in tinnitus research. First, it will seek to quantify the efficacy of multisensory training by pairing behavioral outcomes (Stroop Test, Test of Attention in Listening [TAiL], and Attention Network Test [ANT]) with neurophysiological measures such as quantitative electroencephalography (qEEG) absolute and relative power and P300 evoked potentials. qEEG captures resting-state oscillatory patterns, while P300 latency reflects the allocation of attentional resources—both serving as biomarkers of tinnitus-related cortical reorganization.^5,13 Second, the study will compare modality-specific effects by contrasting auditory or visual-only interventions and the combined AVAT approach. Previous findings suggest that auditory training alone may exacerbate attention bias, whereas multisensory tasks engage cross-modal plasticity to normalize neural activity.^3,4 Third, the trial will aim to map the neural correlates of improvement through source-localized qEEG (via sLORETA), which identifies changes in auditory-limbic hubs such as the dorsolateral prefrontal cortex (DLPFC) and parahippocampal regions—areas known to be hyperconnected in chronic tinnitus.⁴ Moreover, the dissociation of auditory (aP300) and visual (vP300) processing via P300 evoked potentials provides further mechanistic insights into modality-specific plasticity.¹³

Key advancements of AVAT over existing therapies include its neuroplasticity-driven design. Unlike tinnitus retraining therapy (TRT), which emphasizes passive habituation, AVAT actively reshapes neural networks through structured attentional demands.^7,8 Its multimodal integration—combining behavioral tasks with neurophysiological tests—allows for the validation of both clinical and mechanistic outcomes, an approach endorsed by recent implementation reviews.⁶ Furthermore, by correlating qEEG and P300 profiles with symptom reduction, AVAT offers the potential for personalized neuromodulation protocols.^3,13

This protocol aligns with the Conceptual Cognitive Framework (CCF) for tinnitus, which highlights the role of attentional bias and cognitive-emotional interactions in perpetuating distress.⁵ Future studies could incorporate emerging technologies, such as virtual reality (VR), to deliver the training, while the functional effects are thoroughly examined using functional magnetic resonance imaging (fMRI).

Methods

Study design and sample selection

This study will be a three-arm, parallel-group, randomized controlled trial (RCT) with blinded outcome assessment. The study period will encompass a three-week intervention phase, with baseline evaluations conducted prior to the start of the intervention and follow-up evaluations immediately after its completion. All participants will undergo comprehensive pre- and post-intervention evaluations that included behavioral testing, clinical questionnaires, and neurophysiological recordings. The study is designed to compare the efficacy of three different attention training interventions delivered via a custom mobile application. “Any significant protocol modifications will be communicated promptly and transparently to all relevant stakeholders, ensuring compliance with ethical, regulatory, and scientific standards.”

Participants will be adults aged 20–50 years who suffered from chronic subjective tinnitus for more than six months. All subjects will be required to demonstrate normal hearing thresholds—less than 25 decibels hearing level (dB HL) across the standard audiometric range (250–8000 Hz), as confirmed by pure-tone audiometry—and they will be required to be right-handed to standardize electroencephalography (EEG) and P300 recordings. Exclusion criteria include pulsatile or somatic tinnitus, Ménière’s disease, active neurological disorders (e.g., epilepsy), use of psychoactive medications (such as antidepressants or anticonvulsants) within the past three months, and severe psychiatric comorbidities (e.g., major depressive disorder or schizophrenia).

Participants will be instructed to maintain their usual medical care during the study. Additional cognitive training, neurostimulation, or tinnitus-specific interventions will be prohibited to avoid confounding effects. They will report any changes in medication or concomitant treatments throughout the trial. Regular communication with the study team will be encouraged, and participants will be reminded to adhere to the study protocol. All data will remain confidential and not impact their participation. If deviations from the protocol occur, the reasons will be documented and appropriate actions taken. Ongoing support will be provided to address any concerns and manage tinnitus symptoms.

Recruitment, randomization, and blinding

Participants will be recruited through referrals from otolaryngology clinics as well as via advertisements on social media, hospitals, and other healthcare centers. Screening involves audiological testing, a detailed review of medical history, and the administration of the Hospital Anxiety and Depression Scale (HADS) to exclude those with significant psychiatric issues. A statistician will generate a blocked randomization sequence (1:1:1 allocation) using randomization table. The allocation sequence will be implemented through a secure computerized system, ensuring concealment until participants are assigned to their respective intervention groups after baseline assessments.

Interventions

Participants will be randomly assigned to one of three training groups:

• Group 1 (Visual Attention Training): The training in this group will be designed based on visual stimuli.
• Group 2 (Auditory Attention Training): Participants in this group will receive training based on auditory stimuli.
• Group 3 (Combined Visual-Auditory Attention Training): This group will be exposed to training that required simultaneous attention to both visual and auditory stimuli.

The choice of comparators in this study was based on prior research demonstrating differential effects of visual, auditory, and combined attention training on neurophysiological and behavioral outcomes in tinnitus patients. The inclusion of three groups allows for a direct comparison of modality-specific versus multimodal training effects.

All training sessions will be delivered through a dedicated web-based mobile application (compatible with Android and iOS) that provided real-time performance feedback. Each training session will last 30 minutes per day and will continue for three weeks (a total of 21 sessions). This duration was selected based on previous studies to optimally assess the effects of attention interventions on brain activity and cognitive processing in individuals with tinnitus.^14–16 Attention training will be provided in three study groups based on the training objectives. Each individual will have a unique username and password, which will be predefined according to their assigned group.

To enhance adherence to the intervention protocols, participants’ engagement and progress will be continuously monitored through the mobile application. The app will record session completion times, duration, and task performance metrics, which will be securely stored in a cloud-based database accessible only to the research team. Adherence reports will be reviewed daily by the study coordinators, who will follow up with participants showing low engagement through phone calls or messages to address any technical difficulties or motivational barriers.

Given the nature of this study and its limited risks, a separate Data Monitoring Committee is not deemed necessary. Instead, the principal investigator and the ethics committee will oversee the study to ensure participant safety and the integrity of the data. Regular audits will be conducted by the investigators to verify adherence to the protocol, ensure data accuracy, and maintain ethical standards. These audits will follow standardized procedures to preserve objectivity and reduce the potential for conflicts of interest.

Sample size calculation

The sample size has been determined based on previous studies and includes 45 adult participants.^15–17 To determine the sample size, we applied the following formula, which is used for comparing the means of two independent groups:

n = \frac{{(Z_{1 - α / 2} + Z_{1 - β})}^{2} \times (S_{1}^{2} + S_{2}^{2})}{{(μ_{1} - μ_{2})}^{2}}

Where:

$Z_{1 - α / 2}$ is the standard normal value corresponding to the confidence level (e.g., 1.96 for a 95% confidence level).

$Z_{1 - β}$ is the standard normal value corresponding to the test power (e.g., 0.84 for 80% power).

$S_{1}^{2}$ and $S_{2}^{2}$ are the variances of the two groups being compared.

$μ_{1} - μ_{2}$ represents the expected difference between the means of the two groups.

By applying appropriate values from previous studies, the total sample size has been determined to be 45 participants, who will be divided into three groups of 15 individuals each.

Outcome measures

Outcomes will include:

1. Tinnitus severity: Measured using the Persian-validated version of the Tinnitus Handicap Questionnaire (THQ), scored from 0 to 100, with higher scores indicating greater disability.
2. Attention performance: Evaluated by three behavioral tasks:
- ○ Stroop test: Performance on different trials.
- ○ TAiL performance: Mean reaction time and error rate in attend frequency and attend location tasks.
- ○ ANT efficiency: Composite score assessing alerting, orienting, and executive attention.
3. Neurophysiological markers:
- ○ Resting-state quantitative EEG (qEEG) will be used to assess the absolute and relative power across frequency bands using 21 electrode sites.
- ○ Evoked potentials will be measured using P300 latency and amplitude during both auditory (aP300) and visual (vP300) oddball tasks.

Data collection and analysis

EEG recording will be conducted in a dedicated and sound-attenuated room with controlled conditions to minimize environmental and physiological artifacts. Participants will be seated in a comfortable, adjustable chair, and a specialized pillow will be used to reduce muscle noise from head movements. Before recording, electrode impedance will be kept below 10 kΩ, and an electrooculogram (EOG) will be recorded to eliminate artifacts caused by eye blinks.

A “Linked Ear” (LE) reference will be used for electrode placement, referring to electrical signals recorded from either the left or right ear as a reference. The LE reference was selected to synchronize brain signals and minimize unwanted noise, enhancing the accuracy and reliability of electrophysiological data analysis in EEG studies.

EEG data will be recorded at a sampling rate of 1024 Hz using a 21-channel digital EEG recording system. The signals will be bandpass filtered between 0.4 and 200 Hz to eliminate low- and high-frequency noise, improving signal quality and analysis precision.

EEG data collection will be performed in a resting state with eyes closed. This condition was chosen to study baseline brain activity without external stimuli or complex cognitive processes. Resting-state EEG allows for the examination of intrinsic neural activity patterns essential for understanding baseline brain function.¹⁸ Also, closing the eyes reduces artifacts from visual processing and eye movements, ensuring a more accurate analysis of brain activity.¹⁹ Furthermore, many previous studies investigating neurophysiological changes in tinnitus have used this method to enable direct comparisons of findings.²⁰

Following data collection, EEG signals will be processed using the EEG analysis software employed in the study. Preprocessing involves artifact removal using independent component analysis (ICA) and adaptive filtering, followed by frequency band decomposition. The frequency bands include delta (2–3.5 Hz), theta (4–7.5 Hz), alpha 1 (8–10 Hz), alpha 2 (10–12 Hz), beta 1 (13–18 Hz), beta 2 (18.5–21 Hz), beta 3 (21.5–30 Hz), and gamma (30.5–44 Hz). Absolute and relative power for each frequency band will be calculated at each electrode, and results will be reported for the regions of interest (ROI). These analyses help to better understand brain activity patterns and functional differences under various conditions.

Source localization of brain activity will be performed using sLORETA, which provides insights into the spatial distribution of neural activity and functional connectivity between different brain regions. This method allows for detailed mapping of neural networks associated with tinnitus-related changes.

P300 recording with auditory and visual stimuli

The P300 event-related potential (ERP) will be recorded using an oddball paradigm, in which participants will be presented with a sequence of standard and rare stimuli. EEG data will be collected in the same controlled environment as resting-state EEG, using a 21-channel EEG recording system. The highest peak amplitude for each individual will be identified and used for statistical analysis. Electrode impedance will be maintained below 10 kΩ, and data will be recorded at a sampling rate of 1024 Hz using broadband filtering.

Auditory stimuli consist of a 4 kHz pure tone as the standard stimulus and a 6 kHz narrow-band noise as the rare stimulus, each with a duration of 150 ms. Visual stimuli consist of a yellow block as the standard stimulus and a blue block as the rare stimulus, each lasting 300 ms. Stimuli will be presented using Presentation software (Neurobehavioral Systems), a tool designed for precise timing and control in psychological and neuroscience experiments.

The oddball paradigm will involve the separate presentation of auditory and visual stimuli. In each sequence, 80% of the stimuli will be standard and 20% will be rare, presented in a randomized order to prevent participants from predicting the next stimulus. Participants will be instructed to respond to rare stimuli by pressing a button.

P300 peak amplitude and latency in response to rare stimuli will be analyzed across different brain regions using Neuro-Spectrum.NET (the proprietary software of the EEG recording device) and Excel. A copyright license for Neuro-Spectrum has been obtained from the manufacturer. In investigations where Neuro-Spectrum is unavailable or alternative devices are used; it is recommended to employ EEGLab for analysis. EEGLab is open-source software, providing a flexible and accessible option for researchers.²¹ The most representative response will be selected for statistical analysis.

Data will be entered by trained personnel using a double data entry system to ensure accuracy. Range checks will be applied to validate data values, and discrepancies will be resolved. Data will be stored in a secure, password-protected database with access restricted to authorized staff. Physical records will be kept in secure place. Regular audits will ensure data integrity.

Data analysis

Statistical analyses will be performed using IBM SPSS Statistics (version 27). Demographic data, behavioral assessments, and information related to attention training exercises will be analyzed in the same software. The validity of the rehabilitation training protocol and the software used in the intervention will be confirmed before analysis. The normality of data distribution will be assessed using the Shapiro-Wilk test to determine the appropriate statistical tests. Based on the results, parametric tests (e.g., one-way ANOVA and paired t-test) or non-parametric tests (e.g., Wilcoxon Signed-Rank and Kruskal-Wallis) will be applied to compare within-group and between-group changes before and after the intervention.

For EEG data analysis, paired t-tests will be used for within-group EEG comparisons, while one-way ANOVA will be applied for between-group differences. In contrast, questionnaire data will be analyzed using the Wilcoxon Signed-Rank test for within-group comparisons and the Kruskal-Wallis test with Dunn’s post-hoc analysis for between-group comparisons.

The analysis population will be determined according to protocol adherence, utilizing an intention-to-treat (ITT) approach when applicable. For cases of protocol deviations, both per-protocol (PP) and as-randomized analyses will be conducted. To address missing data, multiple imputation methods will be employed to enhance the reliability of statistical outcomes.

Additional methodological details

The audiological assessments will encompass otoscopic examination (utilizing a WelchAllyn otoscope), pure-tone audiometry (conducts with a GSI Pello audiometer), and tympanometry (performs using an Inventis Clarinet device). EEG and P300 responses will be recorded via the Neurosoft Neuro-Spectrum 4/P system. Behavioral tasks, including the Attention Network Test (ANT) and the Stroop test, will be administered using PsychoPy software and TAiL with its author-released software package. Neurophysiological data analysis will be conducted employing Neuro-Spectrum.NET, sLORETA, and NeuroGuide software.

Limitations and mitigation strategies

Potential limitations include:

• Honesty in questionnaire responses: To mitigate the risk of non-genuine answers, participants will receive detailed explanations regarding the importance of accurate responses, assurances of confidentiality, and will be allowed an unlimited time frame for completion.
• Length of questionnaires: To reduce fatigue from lengthy questionnaires, these will be divided into shorter sections with scheduled breaks.
• Daily exercise fatigue: The mobile application will be designed with engaging graphics and positive feedback mechanisms, and participants will receive regular performance reports to maintain motivation.
• Long-term efficacy: Although long-term effects of the intervention remained challenging to assess, future projects could be considered to evaluate outcomes 6 to 12 months post-intervention.

Trial registration

• Registry: Iranian Registry of Clinical Trials (IRCT).
• ID: IRCT20220206053952N2.
• Date: August 10, 2022.
• URL: https://irct.behdasht.gov.ir/trial/65160

Conclusions/Discussion

This study’s multi-modal protocol offers a promising neuromodulatory intervention for chronic tinnitus by integrating behavioral tasks, clinical questionnaires, and neurophysiological biomarkers to elucidate the mechanisms of neural plasticity underlying tinnitus distress. By linking behavioral outcomes to electrophysiological changes, the protocol builds on previous evidence that tinnitus subjects often exhibit impaired attentional processing and maladaptive cortical reorganization.²²

Moreover, the mobile-based delivery system enhances subject accessibility and engagement, which is particularly relevant given the high prevalence and heterogeneous nature of tinnitus. The study’s rigorous design—including blinded assessments, a preregistered protocol, and robust statistical controls—strengthens its internal validity and provides a clear mechanistic focus linking attentional training to neuroplastic recalibration. However, the single-center design may limit the generalizability of these findings to broader, more diverse populations, and the short follow-up period leaves the long-term sustainability of treatment effects uncertain.

Future research should explore optimal training dosages and durations, as well as refine neurophysiological biomarkers for tailoring personalized therapies. In addition, emerging evidence from studies employing predictive coding frameworks indicates that aberrant sensory predictions play a pivotal role in the persistence of tinnitus.²³

Further investigation into how individual differences in baseline neural activity influence responsiveness to auditory-visual attentional training may help identify subgroups of subjects who would benefit most from this intervention. Additionally, longitudinal studies incorporating larger and more diverse subject populations are needed to assess the long-term impact of this training and to determine whether booster sessions are necessary to maintain treatment benefits.

Moreover, future research should examine the interaction between cognitive load and attentional modulation in tinnitus subjects. Since attentional control mechanisms are known to be affected by factors such as working memory capacity and cognitive reserve, assessing these variables in relation to training efficacy could yield valuable insights into the mechanisms underlying tinnitus-related distress reduction. Neuroimaging techniques, such as functional MRI, could complement qEEG and P300 analyses by providing spatial resolution of the neural networks engaged during training, further elucidating the cortical and subcortical changes associated with this intervention. Collectively, these findings underscore the potential of an integrated, multi-modal approach to both advance our understanding of tinnitus pathophysiology and to inform the development of more effective, individualized neuromodulatory interventions.

Software and code

The software and tools used in this study for neurophysiological analysis and behavioral task design are as follows:

• Neurophysiological analysis:
- ○ sLORETA (v20081104) for source localization:
  - ▪ Available at LORETA Official Website: https://www.uzh.ch/keyinst/loreta.htm
  - ▪ License: Non-commercial use only; the software may not be used for commercial or clinical purposes.
- ○ Neuro-Spectrum (EEG Acquisition System Software)
  - ▪ Device and software details are available at official Neurosoft website: https://neurosoft.com/en/catalog/eeg/neuron-spectrum-1-4p
  - ▪ License: Proprietary software; usage is restricted to Neurosoft EEG systems.
• Behavioral task design:
- ○ PsychoPy (v2024.2.4) for Stroop and ANT tasks.
  - ▪ Software installation package available from: https://www.psychopy.org/download.html
  - ▪ License: GNU General Public License v3 (GPL-3.0)
- ○ Stroop Task:
  - ▪ Source code available from: https://github.com/marsja/stroopy
  - ▪ License: GNU General Public License v3 (GPL-3.0)
- ○ ANT:
  - ▪ Source code available from: https://github.com/coneco-lab/modified-ant
  - ▪ License: GNU General Public License v3.0 (GPL-3.0)
- ○ TAiL:
  - ▪ Software installation package and documentation available from: http://doi.org/10.17639/nott.370
  - ▪ License: Non-commercial use only

These software tools were originally developed by other researchers and have been extensively utilized in cognitive neuroscience and neurophysiological research. For the present study, we translated the pertinent components to align with the language of our participants and determined their face validity through a rigorous evaluation process. Detailed information regarding the translated materials has been uploaded to the repository.

Ethics and consent

The study adheres to strict ethical standards, ensuring that participants’ rights will be protected at all stages. Written informed consent will be obtained by an expert audiologist after participants are fully briefed on the study’s objectives, procedures, potential risks, and privacy measures. Given the nature of the study, which involves minimal risk to participants, there are no provisions for ancillary or post-trial care or compensation for harm. The study has been designed to ensure participant safety, and all procedures are non-invasive. Confidentiality will be maintained by coding participant data (12001–12045), and results will be reported in aggregate form. Participants had the right to withdraw at any time without penalty. The study was conducted in full compliance with ethical guidelines and was approved by the Ethics Committee of Iran University of Medical Sciences (Approval Code: IR.IUMS.FMD.REC.1396.9311301007, issued on July 12, 2017).

Access to the final trial dataset will be restricted to the principal investigators and authorized research team members. Any contractual agreements in place will limit access to the dataset for investigators to ensure privacy and confidentiality. The personal information of participants will be kept confidential and stored securely in a dataset at the Department of Audiology, Faculty of Rehabilitation Sciences, Iran University of Medical Sciences. The results of this study will be disseminated through publication in peer-reviewed journals, registration in public databases, and presentations at relevant conferences. Participants will be informed of the results via a summary letter or meeting.

Data and software availability

Underlying data

No data are associated with this article.

Extended data

All relevant study materials have been deposited in Zenodo and are publicly available.

Repository name: Zenodo

Title of project: Repository for Study Materials: Investigating the Efficacy of Auditory-Visual Attentional Training in Chronic Tinnitus, DOI: https://doi.org/10.5281/zenodo.15078874.²⁴

This repository includes:

• 01 Software and Code.docx – The software and tools used in this study.
• 02 Stroop Translation.docx, 03 TAiL Translation.docx, and 04 ANT Translation.docx – These documents provide translations of the instructions and task descriptions used during the administration of these three cognitive tasks.
• 05 SPIRIT-Checklist.docx – The SPIRIT checklist ensuring adherence to clinical trial reporting guidelines.
• Consent Form EN.pdf and consent form Fa.pdf – Informed consent forms in both English (EN) and Persian (FA) for participant agreement.
• HADS questionnaire EN.pdf & HADS questionnaire.pdf – Hospital Anxiety and Depression Scale (HADS) questionnaire in English (EN) and Persian (FA).
• IOWA questionnaire EN.pdf & IOWA questionnaire.pdf – Iowa Tinnitus Handicap Questionnaire in both English (EN) and Persian (FA).
• Time schedule Table.docx – This table represents the timeline of a study, outlining key stages for participant involvement.

Data is licensed under Creative Commons Zero v1.0 Universal

Acknowledgments

This research will be conducted with the support of the Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences. The authors would like to express their appreciation to the participants for their valuable contribution to the study. Special thanks are extended to the families of the researchers for their continuous encouragement and support.

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18. Schomer DL, Lopes da Silva FH: Niedermeyer’s Electroencephalography: Basic Principles, Clinical Applications, and Related Fields. Schomer DL, Lopes da Silva FH, editors: Oxford University Press; 2017.
19. Barry RJ, Clarke AR, Johnstone SJ, et al.: EEG differences between eyes-closed and eyes-open resting conditions. Clin. Neurophysiol. 2007; 118(12): 2765–2773. Publisher Full Text
20. Schlee W, Hartmann T, Langguth B, et al.: Abnormal resting-state cortical coupling in chronic tinnitus. BMC Neurosci. 2009; 10: 11. PubMed Abstract | Publisher Full Text | Free Full Text
21. Delorme A, Makeig S: EEGLAB: an open source toolbox for analysis of single-trial EEG dynamics including independent component analysis. J. Neurosci. Methods. 2004; 134(1): 9–21. PubMed Abstract | Publisher Full Text
22. Cardon E, Joossen I, Vermeersch H, et al.: Systematic review and meta-analysis of late auditory evoked potentials as a candidate biomarker in the assessment of tinnitus. PLoS One. 2020; 15(12): e0243785. PubMed Abstract | Publisher Full Text | Free Full Text
23. Okamoto K, Hoyano K, Saiki Y, et al.: Predictive brain activity related to auditory information is associated with performance in speech comprehension tasks in noisy environments. Front. Hum. Neurosci. 2024; 18: 1479810. PubMed Abstract | Publisher Full Text | Free Full Text
24. Namvar Arefi H, Jarollahi F, Mohsen S, Jalaie S: Repository for Study Materials: Investigating the Efficacy of Auditory-Visual Attentional Training in Chronic Tinnitus. Zenodo. 2025. Publisher Full Text

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Author details Author details

¹ Department of Audiology, Iran University of Medical Sciences, Tehran, Tehran Province, Iran
² Department of Otolaryngology, Faculty of Medicine, Damascus University, Damascus, Syria
³ School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Tehran Province, Iran

Hossein Namvar Arefi
Roles: Conceptualization, Methodology, Validation, Writing – Original Draft Preparation

Farnoush Jarollahi
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Samer Mohsen
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Shohreh Jalaie
Roles: Formal Analysis, Supervision, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

This work is a part of the doctoral thesis in the Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, under the grant number 1400-3-6-22348.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Namvar Arefi H, Jarollahi F, Mohsen S and Jalaie S. Efficacy of auditory-visual attentional training in adults with chronic tinnitus: A study protocol for a randomized controlled trial [version 1; peer review: 1 approved with reservations]. F1000Research 2025, 14:488 (https://doi.org/10.12688/f1000research.162088.1)

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Reviewer Report 03 Jun 2025

Eser Sendesen, Hacettepe University, Ankara, Turkey

Approved with Reservations

https://doi.org/10.5256/f1000research.178217.r385628

The main results of the study should be written under the conclusion title in the abstract.

The pathophysiology of multisensory tinnitus should be explained further. For example, cross-modal plasticity can be seen in the cortical area ... Continue reading

The main results of the study should be written under the conclusion title in the abstract.

The pathophysiology of multisensory tinnitus should be explained further. For example, cross-modal plasticity can be seen in the cortical area as well as in the right brain. This is quite important considering that the hyperactivity in multisensory tinnitus begins in the brainstem. Therefore, it is useful to focus on the pathophysiology of the brainstem.

How is somatic tinnitus excluded?

THQ rates discomfort, not tinnitus severity.

Each result reached should be discussed. In this state, the discussion is quite limited.

Previously applied tinnitus treatments/therapy methods should be discussed with their results.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Partly

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Tinnitus

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Eser Sendesen, Hacettepe University, Ankara, Turkey

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Reviewer Report

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03 Jun 2025 | for Version 1

Eser Sendesen, Hacettepe University, Ankara, Turkey

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Approved With Reservations

The main results of the study should be written under the conclusion title in the abstract.

The pathophysiology of multisensory tinnitus should be explained further. For example, cross-modal plasticity can be seen in the cortical area as well as in the right brain. This is quite important considering that the hyperactivity in multisensory tinnitus begins in the brainstem. Therefore, it is useful to focus on the pathophysiology of the brainstem.

How is somatic tinnitus excluded?

THQ rates discomfort, not tinnitus severity.

Each result reached should be discussed. In this state, the discussion is quite limited.

Previously applied tinnitus treatments/therapy methods should be discussed with their results.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Partly

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Tinnitus

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Respond to this report

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[1] 1. Hackenberg B, O’Brien K, Döge J, et al.: Tinnitus Prevalence in the Adult Population-Results from the Gutenberg Health Study. Medicina (Kaunas). 2023; 59(3). Publisher Full Text

[2] 2. Jarach CM, Lugo A, Scala M, et al.: Global Prevalence and Incidence of Tinnitus: A Systematic Review and Meta-analysis. JAMA Neurol. 2022; 79(9): 888–900.

[3] 3. Shore SE, Roberts LE, Langguth B: Maladaptive plasticity in tinnitus — triggers, mechanisms and treatment. Nat. Rev. Neurol. 2016; 12(3): 150–160. PubMed Abstract | Publisher Full Text | Free Full Text

[4] 4. Eggermont JJ: Neuroplasticity of the Auditory System.Schlee W, Langguth B, De Ridder D , et al., editors. Textbook of Tinnitus. Cham: Springer International Publishing; 2024; pp. 149–163.

[5] 5. Ghodratitoostani I, Vaziri Z, Miranda Neto M, et al.: Conceptual framework for tinnitus: a cognitive model in practice. Sci. Rep. 2024; 14(1): 7186. PubMed Abstract | Publisher Full Text | Free Full Text

[6] 6. Burton-Harris LJ, Sanders PJ, Searchfield GD: An implementation science systematic review of neurophysiological evidence indicates the tinnitus core network as a therapeutic target. Front. Audiol. Otol. 2023; 1: 1. Publisher Full Text

[7] 7. Jastreboff PJ: Tinnitus retraining therapy. Prog. Brain Res. 2007; 166: 415–423. Publisher Full Text

[8] 8. Kroener-Herwig B, Biesinger E, Gerhards F, et al.: Retraining therapy for chronic tinnitus. A critical analysis of its status. Scand. Audiol. 2000; 29(2): 67–78. PubMed Abstract | Publisher Full Text

[9] 9. McGurk H, MacDonald J: Hearing lips and seeing voices. Nature. 1976; 264(5588): 746–748. PubMed Abstract | Publisher Full Text

[10] 10. McDonald JJ, Ward LM: Involuntary listening aids seeing: evidence from human electrophysiology. Psychol. Sci. 2000; 11(2): 167–171. PubMed Abstract | Publisher Full Text

[11] 11. McDonald JJ, Teder-Salejarvi WA, Heraldez D, et al.: Electrophysiological evidence for the “missing link” in crossmodal attention. Can. J. Exp. Psychol. 2001; 55(2): 141–149. PubMed Abstract | Publisher Full Text

[12] 12. Kayser C, Petkov CI, Logothetis NK: Visual modulation of neurons in auditory cortex. Cereb. Cortex. 2008; 18(7): 1560–1574. Publisher Full Text

[13] 13. Wang K, Tang D, Ma J, et al.: Auditory Neural Plasticity in Tinnitus Mechanisms and Management. Neural Plast. 2020; 2020: 1–17. Publisher Full Text

[14] 14. Searchfield GD, Morrison-Low J, Wise K: Object identification and attention training for treating tinnitus. Prog. Brain Res. 2007; 166: 441–460. PubMed Abstract | Publisher Full Text

[15] 15. Spiegel DP, Linford T, Thompson B, et al.: Multisensory attention training for treatment of tinnitus. Sci. Rep. 2015; 5: 10802.

[16] 16. Wise K, Kobayashi K, Magnusson J, et al.: Randomized Controlled Trial of a Perceptual Training Game for Tinnitus Therapy. Games Health J. 2016; 5(2): 141–149. PubMed Abstract | Publisher Full Text

[17] 17. Husain FT, Akrofi K, Carpenter-Thompson JR, et al.: Alterations to the attention system in adults with tinnitus are modality specific. Brain Res. 2015; 1620: 81–97. PubMed Abstract | Publisher Full Text

[18] 18. Schomer DL, Lopes da Silva FH: Niedermeyer’s Electroencephalography: Basic Principles, Clinical Applications, and Related Fields. Schomer DL, Lopes da Silva FH, editors: Oxford University Press; 2017.

[19] 19. Barry RJ, Clarke AR, Johnstone SJ, et al.: EEG differences between eyes-closed and eyes-open resting conditions. Clin. Neurophysiol. 2007; 118(12): 2765–2773. Publisher Full Text

[20] 20. Schlee W, Hartmann T, Langguth B, et al.: Abnormal resting-state cortical coupling in chronic tinnitus. BMC Neurosci. 2009; 10: 11. PubMed Abstract | Publisher Full Text | Free Full Text

[21] 21. Delorme A, Makeig S: EEGLAB: an open source toolbox for analysis of single-trial EEG dynamics including independent component analysis. J. Neurosci. Methods. 2004; 134(1): 9–21. PubMed Abstract | Publisher Full Text

[22] 22. Cardon E, Joossen I, Vermeersch H, et al.: Systematic review and meta-analysis of late auditory evoked potentials as a candidate biomarker in the assessment of tinnitus. PLoS One. 2020; 15(12): e0243785. PubMed Abstract | Publisher Full Text | Free Full Text

[23] 23. Okamoto K, Hoyano K, Saiki Y, et al.: Predictive brain activity related to auditory information is associated with performance in speech comprehension tasks in noisy environments. Front. Hum. Neurosci. 2024; 18: 1479810. PubMed Abstract | Publisher Full Text | Free Full Text

[24] 24. Namvar Arefi H, Jarollahi F, Mohsen S, Jalaie S: Repository for Study Materials: Investigating the Efficacy of Auditory-Visual Attentional Training in Chronic Tinnitus. Zenodo. 2025. Publisher Full Text

Efficacy of auditory-visual attentional training in adults with chronic tinnitus: A study protocol for a randomized controlled trial

Abstract

Background

Methods

Conclusion

Trial registration

Keywords

Introduction

Methods

Study design and sample selection

Recruitment, randomization, and blinding

Interventions

Sample size calculation

Outcome measures

Data collection and analysis

P300 recording with auditory and visual stimuli

Data analysis

Additional methodological details

Limitations and mitigation strategies

Trial registration

Conclusions/Discussion

Software and code

Ethics and consent

Data and software availability

Underlying data

Extended data

Acknowledgments

References

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