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

Trial Summary

What is the purpose of this trial?

This trial uses a special sound therapy to help Veterans with chronic tinnitus. The therapy involves listening to sounds with a specific part removed to help reduce the ringing in the ears. The goal is to find out if this method can effectively lower the loudness of tinnitus and improve overall well-being. This sound therapy has been suggested to be effective for relieving 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. It is best to discuss this with the study coordinators or your doctor.

Is Notched Noise Therapy safe for humans?

The research articles provided do not specifically address the safety of Notched Noise Therapy, but they focus on its effectiveness for tinnitus relief. No safety concerns are mentioned in the studies, suggesting it may be generally safe, but specific safety data is not provided. ^{1 2 3 4 5}

How does Notched Noise Therapy for Tinnitus differ from other treatments?

Notched Noise Therapy is unique because it uses sound with a specific frequency range removed (notched) to target the tinnitus frequency, potentially reducing tinnitus loudness more effectively than other sound therapies. This personalized approach contrasts with conventional treatments that use constant broadband noise or nature sounds, which may not be as effective for all individuals. ^{2 3 4 5 6}

What data supports the effectiveness of Notched Noise Therapy for Tinnitus?

Research shows that using notched noise, which is sound with a specific frequency removed, can significantly reduce the loudness of tinnitus over time compared to other types of sound therapy. This suggests that personalized sound treatments like notched noise therapy can be effective for managing tinnitus. ^{2 3 4 5 7}

Research Team

Candice Manning Quinn, PhD AuD

Principal Investigator

Durham VA Medical Center, Durham, NC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

The windowed sound therapy: a new empirical approach for an effectiv personalized treatment of tinnitus. [2009]

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

Notched and Nonnotched Stimuli Are Equally Effective at the Mixing-Point Level in Sound Therapy for Tinnitus Relief. [2021]

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

Conventional versus notch filter amplification for the treatment of tinnitus in adults with mild-to-moderate hearing loss. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Comparison of acoustic therapies for tinnitus suppression: a preliminary trial. [2019]

5. Turkey pubmed.ncbi.nlm.nih.gov

A Randomized, Controlled Trial of Notched Music Therapy for Tinnitus Patients. [2022]

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

A Three-arm, Single-blind, Randomized Controlled Trial Examining the Effects of Notched Music Therapy, Conventional Music Therapy, and Counseling on Tinnitus. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A Mixed-Methods Trial of Broad Band Noise and Nature Sounds for Tinnitus Therapy: Group and Individual Responses Modeled under the Adaptation Level Theory of Tinnitus. [2020]