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?

The purpose of this study is to learn more about a type of tinnitus (ringing in the ears) known as "somatosensory tinnitus." This type of tinnitus is suspected when the tinnitus perception changes following head and/or neck movements. This study is also exploring a possible way to treat somatosensory tinnitus.

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 multimodal therapy for tinnitus safe for humans?

The research on tinnitus retraining therapy (TRT), which includes counseling and sound therapy, suggests it is generally safe for humans. There are no significant safety concerns reported in the studies reviewed. ^{1 2 3 4 5}

How is the Multimodal Therapy for Tinnitus different from other treatments?

This treatment is unique because it combines multiple approaches, including physical therapy, sound-based therapy, and cognitive-behavioral therapy, to address tinnitus from different angles. It focuses on personalized care by considering individual needs and includes structured counseling and exercises to improve overall quality of life, unlike standard treatments that may focus on just one aspect. ^{1 3 6 7 8}

What data supports the effectiveness of the treatment Multimodal Therapy for Tinnitus?

Research shows that Tinnitus Retraining Therapy (TRT), which combines counseling and sound therapy, can help reduce the negative reactions and awareness of tinnitus. Studies have also explored the effectiveness of small-group counseling as a time-efficient alternative to individual counseling in managing chronic tinnitus. ^{1 3 4 5 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]

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]

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]

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]

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]

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]

Citations

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The state of the art of sound therapy for subjective tinnitus in adults. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Association between tinnitus retraining therapy and a tinnitus control instrument. [2009]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Small-group counseling in a modified tinnitus retraining therapy for chronic tinnitus. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. Brazil pubmed.ncbi.nlm.nih.gov

Group therapy for patients with tinnitus at the University of Brasilia Medical School. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Tinnitus activities treatment. [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

[TRT and psychotherapy in the treatment of tinnitus]. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Tinnitus Activities Treatment with Total and Partial Masking. [2022]