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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
Motivated and capable of participating (including ability to communicate in English)
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

Study Summary

This trial will compare different methods of sound-based therapy to help with tinnitus, specifically "ringing in the ears." It will focus on the method with the strongest scientific rationale, which is noise that is notched around the predominant tinnitus-frequency region.

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.Check my eligibility
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.See study design
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 am willing and able to participate and can communicate in English.
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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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change of Tinnitus Functional Index Scores from Baseline at 4 weeks, 8 weeks, and 12 weeks
Secondary outcome measures
Change of Tinnitus Loudness Match from Baseline at 4 weeks, 8 weeks, and 12 weeks
Other outcome measures
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.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,495 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies left in this clinical trial?

"According to clinicaltrials.gov, this medical study is not recruiting any new patients at present. Initially posted on November 1st 2022 and most recently updated on September 2nd 2022, the trial has concluded its recruitment efforts but there are 45 other trials that need participants right now."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
California
Other
North Carolina
How old are they?
65+
18 - 65
What site did they apply to?
Durham VA Medical Center, Durham, NC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

TINNITUS IS A BURDEN. I NEED HELP WITH MY TINNUTIS. I've had the condition for around 10 years and there has been NO relief.
PatientReceived 2+ prior treatments
My tennitus is slowly getting worse, ie., louder. Like to start some form of treatment if there is a chance it will work.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long do the screening visits last?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Notched Noise Therapy for Suppression of Tinnitus
2023. "Notched Noise Therapy for Suppression of Tinnitus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04661995.
All > Tinnitus High Point > Tinnitus
~71 spots leftby May 2026
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