Notched Noise Therapy for Tinnitus

Recruiting in Palo Alto (17 mi)

Overseen ByCandice Manning Quinn, PhD AuD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

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.

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.

+14 more

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.

+1 more

Participant Groups

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.

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.