Notched Noise Therapy for Tinnitus

Overseen By Candice M Quinn, PhD AuD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Hearing loss, Meniere's disease, others

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test sound-based treatments to help Veterans manage tinnitus, the persistent ringing in the ears. Participants will try different sound therapies, including Notched Noise Therapy, which adjusts noise around the specific pitch of their tinnitus, to determine if it reduces the ringing or its impact on daily life. Veterans with constant tinnitus, who use hearing aids and have some hearing loss, might be a good fit for this trial. As an unphased trial, this study offers Veterans a unique opportunity to explore innovative sound therapies that could improve their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study coordinators or your doctor.

What prior data suggests that these acoustic-stimulus methods are safe for tinnitus treatment?

Research has shown that Notched Noise Therapy, a sound-based treatment for tinnitus, is generally safe. Studies have not identified any major safety issues, indicating that people tolerate this therapy well. This treatment involves listening to sounds with certain frequencies removed, which might help lessen the ringing in the ears. Some individuals have reported a reduction in their tinnitus symptoms after using this therapy.

Broadband Noise is another commonly used sound therapy for tinnitus and is considered safe. It involves listening to a steady sound, like white noise, which can help mask the ringing caused by tinnitus.

Both therapies appear to be safe options for managing tinnitus symptoms, with no significant side effects reported in the reviewed studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Notched Noise Therapy for tinnitus because it offers a more personalized approach by tailoring the sound therapy to the individual's unique tinnitus pitch. Unlike standard treatments like broadband or white noise, which use generic sound profiles, Notched Noise Therapy targets the specific frequency range of a person's tinnitus, potentially improving effectiveness. This targeted approach might lead to better long-term relief for sufferers by potentially reducing the perception of tinnitus more efficiently.

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

Research has shown that Notched Noise Therapy, one of the treatments in this trial, can reduce the severity of tinnitus, the ringing in the ears experienced by many. In this therapy, patients listen to sounds with a specific frequency removed. One study found that this significantly reduced symptoms for many patients. After three months of therapy, scores on the Tinnitus Handicap Inventory (THI) and Visual Analog Scale (VAS) showed noticeable improvement. Evidence also suggests that longer daily sessions of sound therapy can lead to better results. However, results can vary, and some studies have shown mixed outcomes. Participants in this trial may receive Notched Noise Therapy, Broadband Noise, or Amplification Only, each as separate treatment arms. ^{1 3 6 7 8}

Who Is on the Research Team?

Candice Manning Quinn, PhD AuD

Principal Investigator

Durham VA Medical Center, Durham, NC

Are You a Good Fit for This Trial?

This trial is for Veterans with constant tinnitus and hearing loss, who can communicate in English and understand the study. They must have a specific level of hearing threshold loss, tinnitus within certain frequencies, no middle-ear disease, and be mentally capable to participate as shown by their MMSE score.

Inclusion Criteria

I am willing and able to participate and can communicate in English.

You scored 24 or higher on a test that checks your memory and thinking skills.

I am motivated and can communicate in English.

Exclusion Criteria

Your hearing test shows that you have trouble hearing quiet sounds.

I might have tinnitus due to another health issue but haven't been diagnosed yet.

You have any mental, emotional, or health conditions that would make it difficult for you to fully take part in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive acoustic therapy using ear-level devices for 8 weeks, with outcome measures assessed at baseline, 4 weeks, and 8 weeks

8 weeks

3 visits (in-person) at baseline, 4 weeks, and 8 weeks

Follow-up

Participants are monitored for maintenance of effects without receiving acoustic therapy for 4 weeks, with assessments at 12 weeks

4 weeks

1 visit (in-person) at 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Broadband Noise
• Hearing Aid
• Notched Noise Therapy

Trial Overview The trial tests three methods: a hearing aid combined with notched noise therapy (designed to suppress tinnitus), a hearing aid with broadband noise, and just a hearing aid. It's randomized to see which method best modifies tinnitus-related neural activity.

How Is the Trial Designed?

Group I: Amplification + Notched Noise Therapy Experimental Treatment 1 Intervention

Following the baseline assessment, participants will be randomly assigned to one of the study groups. This treatment group will include a Notched Noise Therapy, a 1-10 kHz noise "notched" within a 1-octave range centered around the psychoacoustic tinnitus pitch match measured. Randomized participants will wear their hearing aids with this loaded software for 8 weeks. They will be seen at a baseline, 4 week, and 8 week visits for outcome measures and any adjustments in hearing aid comfort.

Group II: Amplification + Broadband Noise Active Control 1 Intervention

Following the baseline assessment, participants will be randomly assigned to one of the study groups. A popular and commonly used sound therapy treatment, this treatment group will listen to a broadband noise, or "white noise," that is housed on the manufacturer's hearing aid tinnitus program. They will be seen at a baseline, 4 week, and 8 week visits for outcome measures and any adjustments in hearing aid comfort.

Group III: Amplification Only Placebo Group 1 Intervention

Following the baseline assessment, participants will be randomly assigned to one of the study groups. Hearing aids are ear-level, self-contained, FDA-approved hearing device. Hearing aids help individuals with hearing loss and provide safe amplification/gain to frequencies that have loss.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9450089/

A Randomized, Controlled Trial of Notched Music Therapy ... After 3 months, the Tinnitus Handicap Inventory (THI) and the Visual Analog Scale (VAS) scores were statistically significantly reduced. We also found that ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11511275/

The Effectiveness of Cognitive Behavioral Therapy versus ... In a comparison of the effect of the two therapies, CBT was found to be more effective in decreasing tinnitus-related distress, whereas SNT was ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04661995

Notched Noise Therapy for Suppression of Tinnitus Recent research has shown the benefit of one such acoustic therapy, Notched Noise Therapy, that presents wideband sound with the tinnitus frequency region ...

4. pubs.asha.org pubs.asha.org/doi/10.1044/2022_JSLHR-21-00651

The Impact of Daily Hours of Sound Therapy on Tinnitus ... Based on several outcome measures, this study showed that a higher effectiveness of sound therapy was observed with a longer daily duration (see Figures 3 and 4) ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0196070924002539

Efficacy of tailor-made notched music training for primary ... Some have reported significant reductions in tinnitus loudness and related distress [14,16], while others have found no significant effects on primary outcome ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4704553/

Feasibility and Safety of Transcutaneous Vagus Nerve ... The tinnitus awareness score decreased (i.e., improved) in 13/25 patients (52.0%), was unchanged in 8/25 patients (32.0%), and increased in 4/25 ...

7. ata.org ata.org/about-tinnitus/therapy-and-treatment-options/new-emerging-therapies/

New-to-Market/Emerging Therapies While the device does not eliminate tinnitus, clinical trials and real-world data have shown that it can significantly reduce tinnitus symptoms, particularly ...

8. withpower.com withpower.com/trial/phase-tinnitus-2022-77577

Notched Noise Therapy for Tinnitus No safety concerns are mentioned in the studies, suggesting it may be generally safe, but specific safety data is not provided.