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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
Awards & highlights

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 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.

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.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,359,962 Total Patients Enrolled
6 Trials studying Tinnitus
462 Patients Enrolled for Tinnitus
Candice Manning Quinn, PhD AuDPrincipal InvestigatorDurham VA Medical Center, Durham, NC

Media Library

Tinnitus Research Study Groups: Amplification + Notched Noise Therapy, Amplification + Broadband Noise, Amplification Only
Broadband Noise 2023 Treatment Timeline for Medical Study. Trial Name: NCT04661995 — N/A
~57 spots leftby May 2026
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