Hearing Aid and Notched Noise Therapy for Tinnitus
Durham VA Medical Center, Durham, NC, Durham, NC
Targeting 2 different conditionsHearing Aid and Notched Noise Therapy +2 moreN/ARecruitingLed by Candice Manning Quinn, PhD AuDResearch Sponsored by VA Office of Research and DevelopmentEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
no active middle-ear disease
a score of 24 or higher on the Mini Mental State Exam (MMSE)
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up4 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.
Eligible Conditions
- Tinnitus
- Notched Noise Therapy
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have constant ringing in one or both ears.
Select...
You have a score of at least 25 out of 100 on a test called the Tinnitus Functional Index (TFI), which measures how tinnitus (ringing in the ears) affects your life.
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
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 site
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,553 Previous Clinical Trials
2,887,817 Total Patients Enrolled
6 Trials studying Tinnitus
462 Patients Enrolled for Tinnitus
Candice Manning Quinn, PhD AuDPrincipal Investigator
Durham VA Medical Center, Durham, NCMedia Library
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
What questions have other patients asked about this trial?
How long do the screening visits last?
Patient
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.
Patient
As a disabled vet, my tinnitus has gotten worse. It would really help me personally if there was a way to help reduce the symptoms.
Patient