What side effects are associated with this type of intervention?

Common treatments for tinnitus, such as sound-based (acoustic) therapies including Notched Acoustic Therapy, generally aim to modify tinnitus-related neural activity. Known side effects of these treatments are minimal, but they can include temporary discomfort or irritation from the use of ear-level devices. Other potential side effects may include a temporary increase in tinnitus perception or mild ear discomfort. Overall, these treatments are considered safe with few serious adverse effects reported.

What prior FDA approvals exist?

The provided context does not mention any specific FDA approvals for treatments directly targeting tinnitus through methods similar to Notched Acoustic Therapy. However, it does highlight the use of various acoustic-stimulus protocols in commercial devices aimed at modifying tinnitus-related neural activity. These methods are being studied for their potential to suppress tinnitus and reduce its functional effects, but no specific FDA-approved drugs or devices for this purpose are detailed in the context.

What other types of research exist?

Promising, novel alternatives to Notched Acoustic Therapy for tinnitus patients in 2024 include: 1) Neuromodulation techniques such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), which aim to alter neural activity associated with tinnitus. 2) Pharmacological treatments targeting specific neural pathways involved in tinnitus, such as NMDA receptor antagonists and potassium channel modulators. 3) Advanced sound-based therapies, including customized sound therapy and auditory-sensory training, which use personalized sound profiles to reduce tinnitus perception.

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Notched Noise Therapy for Tinnitus

N/A

Waitlist Available

Led By Candice Manning Quinn, PhD AuD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

unilateral or bilateral constant tinnitus

Unilateral or bilateral constant tinnitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 time points/visits: baseline, 4 weeks, 8 weeks, 12 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort from wearing devices or possible worsening of tinnitus symptoms due to sound therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience constant ringing in one or both ears.

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I experience constant ringing in one or both ears.

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I do not have any current ear infections.

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I do not have an active ear infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 time points/visits: baseline, 4 weeks, 8 weeks, 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 time points/visits: baseline, 4 weeks, 8 weeks, 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 time points/visits: baseline, 4 weeks, 8 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change of Tinnitus Functional Index Scores from Baseline at 4 weeks, 8 weeks, and 12 weeks

Secondary study objectives

Change of Tinnitus Loudness Match from Baseline at 4 weeks, 8 weeks, and 12 weeks

Other study objectives

Change of Electroencephalography (EEG) power in delta, theta, alpha, beta, and gamma bands from Baseline to 8 weeks

Change of N100, P200, and P300 Auditory Evoked Potentials (AEPs) from Baseline to 8 weeks

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Amplification + Notched Noise TherapyExperimental Treatment1 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 NoiseActive Control1 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 OnlyPlacebo Group1 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.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for tinnitus, such as Notched Acoustic Therapy, work by modifying tinnitus-related neural activity. These sound-based therapies use specific acoustic stimuli to reduce hyperactivity in the auditory cortex, which is believed to be a key factor in the perception of tinnitus. By targeting these neural mechanisms, these treatments aim to alleviate the symptoms of tinnitus, thereby improving the quality of life for patients.