Multimodal Therapy for Tinnitus

Overseen By Sarah Theodoroff, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Middle ear pathology, orofacial pathology, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores treatments for somatosensory tinnitus, a type of ringing in the ears that changes with head or neck movements. Researchers are testing three approaches: individualized physical therapy, sound-based therapy, and a combination of both (referred to as Combination Therapy). The goal is to determine which method most effectively reduces bothersome tinnitus symptoms. Ideal participants have experienced constant tinnitus for more than six months and notice changes in their tinnitus when moving their head, neck, or jaw. As an unphased trial, this study allows participants to contribute to pioneering research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that physical therapy can alleviate symptoms of somatosensory tinnitus. In some studies, patients who underwent physical therapy reported less intense tinnitus and reduced pain. This indicates that physical therapy is generally safe and might benefit individuals with this type of tinnitus.

Conversely, results for combination therapy, which includes sound-based treatments, are mixed. Some reviews find no clear benefits, while others suggest that hearing aids and sound therapy can improve symptoms for some individuals. Although strong evidence for the effectiveness of these treatments is lacking, they have not been linked to major safety issues.

Overall, physical therapy appears safe and possibly beneficial for somatosensory tinnitus. Combination therapy, though not strongly proven effective, also shows no significant safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for tinnitus because they offer a unique blend of approaches that could significantly improve patient outcomes. Unlike standard treatments, which typically focus on sound-based therapy alone, this multimodal approach combines individualized physical therapy with sound-based therapy in the Combination Therapy group. This integration allows for a more tailored treatment, addressing both auditory and physical contributors to tinnitus. The Individualized Physiotherapy arm is particularly noteworthy as it customizes exercises to each participant's needs, potentially enhancing the effectiveness of traditional sound therapy. Overall, these innovative combinations could lead to more comprehensive relief for those struggling with tinnitus.

What evidence suggests that this trial's treatments could be effective for somatosensory tinnitus?

Research has shown that combining sound therapy with hearing aids can ease the discomfort of tinnitus. Participants in the Combination Therapy arm of this trial may receive this treatment, which can significantly improve hearing and reduce the perception of ringing in the ears.

Physical therapy, another treatment option in this trial, shows promise, particularly for tinnitus linked to neck and jaw issues. Studies indicate that exercises and manual therapy targeting these areas can reduce tinnitus severity by addressing physical problems contributing to the ringing.

Both therapies have evidence supporting their effectiveness, offering hope for those with tinnitus. ^{4 6 7 8 9}

Who Is on the Research Team?

Sarah Theodoroff, PhD

Principal Investigator

VA Portland Health Care System, Portland, OR

Are You a Good Fit for This Trial?

This trial is for people who have had constant, bothersome tinnitus for at least six months and can change the perception of their tinnitus by moving their head, neck, or jaw. It's not suitable for those with middle ear problems, recent injuries to the jaw area, or active issues in the mouth and face.

Inclusion Criteria

I have tinnitus that is loud and bothers me.

I can change my tinnitus sound by moving my head, neck, or jaw.

I have had constant ringing in my ears for over 6 months.

Exclusion Criteria

You have had a jaw injury in the last 3 months.

I have a middle ear condition.

I have an active disease in my mouth or face.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive individualized physical therapy, sound-based therapy, or a combination of both for somatosensory tinnitus

12 weeks

Regular visits as per treatment protocol

Follow-up

Participants are monitored for changes in tinnitus functional index (TFI) score post-treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Combination Therapy
• Physical Therapy
• Sound-based Therapy

Trial Overview The study tests three treatments: physical therapy alone, sound-based therapy alone, and a combination of both. The goal is to see which method best alleviates somatosensory tinnitus—where symptoms are affected by certain movements.

How Is the Trial Designed?

Group I: Individualized Physiotherapy Experimental Treatment 1 Intervention

Individuals randomized to this group will receive physical therapy, personalized for the participant's specific needs, and include exercises to be performed at home.

Group II: Combination Therapy Experimental Treatment 1 Intervention

Individuals randomized to this group will receive both individualized physical therapy and sound-based therapy.

Group III: Sound-based Therapy Active Control 1 Intervention

Individuals randomized to this group will receive sound-based therapy, consistent with an audiology-based standard of care treatment.

Combination Therapy is already approved in European Union, United States for the following indications:

Approved in European Union as Combination Therapy for Tinnitus for:

• Tinnitus management
• Chronic subjective tinnitus

Approved in United States as Combination Therapy for Tinnitus for:

• Tinnitus management
• Chronic subjective tinnitus

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Tinnitus retraining therapy (TRT) showed a faster response in reducing tinnitus symptoms compared to partial TRT (pTRT) and standard of care (SOC), with significant differences in the time taken to achieve symptom relief.

The use of sound generators in TRT improved the efficiency of treatment without compromising its overall effectiveness, indicating that the sound therapy component enhances the speed of recovery from tinnitus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contributions of Counseling and Sound Generator Use in Tinnitus Retraining Therapy: Treatment Response Dynamics Assessed in a Secondary Analysis of a Randomized Trial. Formby, C., Yang, X., Scherer, RW.[2022]

Tinnitus retraining therapy (TRT) using a tinnitus control instrument (TCI) showed significant improvement in tinnitus symptoms as early as one month into treatment, based on assessments using the Tinnitus Handicap Inventory (THI) and Visual Analogue Scale (VAS).

Patients preferred speech noise and white noise for therapy, with those using speech noise experiencing quicker improvements in their symptoms compared to those using white noise, suggesting that the type of sound used in TRT can influence treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between tinnitus retraining therapy and a tinnitus control instrument. Ito, M., Soma, K., Ando, R.[2009]

A study involving 149 chronic tinnitus patients found that small-group counseling was as effective as individual counseling when combined with modified tinnitus retraining therapy (TRT) and medications, showing similar treatment outcomes over 6 months.

Both counseling methods resulted in significant reductions in tinnitus severity scores, with a success rate of 70% for individual counseling and 64% for small-group counseling, indicating that small-group sessions can be a practical alternative in busy clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Small-group counseling in a modified tinnitus retraining therapy for chronic tinnitus. Park, SN., Bae, SC., Kim, DK., et al.[2021]

In a study involving 151 military personnel with moderate to severe tinnitus, tinnitus retraining therapy (TRT) did not show significant differences in efficacy compared to standard care or partial TRT, suggesting that all treatments may provide similar benefits.

Despite the lack of difference between treatment groups, about 77.5% of participants experienced clinically meaningful reductions in tinnitus severity after 18 months, indicating that while TRT may not be superior, it can still be effective for many individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Tinnitus Retraining Therapy vs Standard of Care on Tinnitus-Related Quality of Life: A Randomized Clinical Trial. Scherer, RW., Formby, C.[2023]

In a study evaluating tinnitus treatment effectiveness, participants without hearing aids showed the most significant improvement in tinnitus symptoms, with a 25% average decrease in the Tinnitus Handicap Questionnaire (THQ) for those using total masking techniques.

For participants with hearing aids, the average decrease in THQ scores was modest, with no significant differences among the treatment groups, suggesting that individual expectations may play a crucial role in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tinnitus Activities Treatment with Total and Partial Masking. Tyler, RS., Stocking, C., Ji, H., et al.[2022]

Tinnitus Activities Treatment is a comprehensive approach that addresses not just the symptoms of tinnitus but also the individual's thoughts, emotions, communication, sleep, and concentration, making it a holistic intervention.

The treatment employs Partial Masking Sound Therapy, using low-level noise or music to provide relief, and incorporates interactive elements like homework and activities to enhance patient engagement and understanding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tinnitus activities treatment. Tyler, RS., Gogel, SA., Gehringer, AK.[2018]

Tinnitus retraining therapy (TRT) combined with psychotherapeutic approaches, such as cognitive behavioral therapy, is more effective than the classic TRT alone, especially when using validated diagnostic tools like the Tinnitus Questionnaire.

The effectiveness of tinnitus treatment varies based on the severity of the condition and associated hearing issues, suggesting that a tailored, staged approach to therapy is beneficial for different patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[TRT and psychotherapy in the treatment of tinnitus]. Schaaf, H., Gieler, U.[2021]

A group therapy program for tinnitus, combining tinnitus retraining therapy and cognitive behavioral techniques, was successfully implemented in Brazil with 27 participants, of which 19 completed the treatment.

Results showed significant improvements in tinnitus symptoms, as measured by the Tinnitus Handicap Inventory and Hospital Anxiety and Depression Scale, indicating the therapy's effectiveness in reducing both functional and emotional impacts of tinnitus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group therapy for patients with tinnitus at the University of Brasilia Medical School. Holdefer, L., Oliveira, CA., Venosa, AR.[2022]

Customized sound therapy tends to be more effective than non-customized options for managing tinnitus, especially in patients with more severe initial symptoms, based on a review of 43 studies.

While sound therapy shows promise in suppressing tinnitus, there is a need for more randomized controlled trials to determine the best management strategies and to develop personalized treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The state of the art of sound therapy for subjective tinnitus in adults. Wang, H., Tang, D., Wu, Y., et al.[2022]

Citations

1. frontiersin.org frontiersin.org/journals/audiology-and-otology/articles/10.3389/fauot.2024.1322596/full

Impact of a combination sound therapy on tinnitus distress A combination sound therapy consisting of therapy sounds, amplification as needed, and counseling was associated with a reduction in tinnitus-related distress.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25211767/

Validation of a novel combination hearing aid and tinnitus ... Conclusions: Results of this study suggest that the use of hearing aids alone or hearing aids plus the use of sound generators both provide significant benefit ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0385814621000195

Effective sound therapy using a hearing aid and ... The results of this study suggest that treatment with sound therapy may ameliorate the symptoms of chronic tinnitus associated with hearing loss.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8975392/

Combined Amplification and Sound Therapy for Individuals ... The study results suggest that combined amplification and sound therapy is beneficial in individuals with tinnitus and coexisting hearing loss in reducing ...

5. ncrar.research.va.gov ncrar.research.va.gov/Publications/Documents/ValidationOfNovelCombHA-TinnitusDevice.pdf

Validation of a Novel Combination Hearing Aid and Tinnitus ... The primary purpose of either the combination instruments or the hearing aids is to mitigate the tinnitus, with improved audibility considered a secondary ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7664457/

Combined Amplification and Sound Generation for Tinnitus Eight out of nine literature reviews concluded a lack of evidence for efficacy of combination aids or sound therapy, in general, in the management of tinnitus.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04663828

UNification of Treatments and Interventions for TInnitus ... The study includes a 12-week treatment trial for chronic tinnitus patients using 4 different types of interventions (hearing aids, sound therapy, structured ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8519222/

Efficacy of sound therapy interventions for tinnitus ... An example of the search strategy for PubMed/MEDLINE is (“tinnitus” AND (“masking therapy” OR “tinnitus retraining therapy” OR “hearing aids” OR ...

9. ijorl.com ijorl.com/index.php/ijorl/article/view/4027

Combined sound conditioning therapy and counseling for ... Hearing aids as an adjunct to counseling: tinnitus patients who choose amplification do better than those that don't. Int J Audiol. 2010;49(8): ...