NCT03511807

Acoustic and Electrical Stimulation for the Treatment of Tinnitus

Active, enrolled NA Last updated 27 April 2025

What this trial tests

NA trial testing Electrical in Tinnitus in 100 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 January 2017

Primary endpoint
30 June 2026

30 June 2026

Quick facts

Lead sponsor	University of California, Irvine
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 January 2017
Primary completion	30 June 2026
Estimated completion	30 June 2026
Sites	1 location across United States

Drugs / interventions tested

• Electrical
• Acoustic

Conditions studied

• Tinnitus — all drugs for Tinnitus →

Sponsor

University of California, Irvine

Who can join

18 and older, any sex, with Tinnitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Tinnitus, or ringing in the ears, affects 10% to 30% of the population. Of those, 20% have tinnitus bothersome enough to seek medical attention. In many people, tinnitus can significantly affect the quality of life. At this point in time, there is no effective treatment or cure available for tinnitus.

It has been found that electrical stimulation of the inner ear can reduce and in some cases eliminate tinnitus. The purpose of this research is to investigate both acoustic and electrical stimulation of the inner ear as a possible treatment of tinnitus.

In both acoustic and electrical testing conditions, the subjects will be instructed to be familiar with a 0-10 ranking scale of loudness. In acoustic testing, the stimulus will be presented through headphones in a noiseless environment, and the subject will be asked to report on the loudness of the presented sound and the level of the tinnitus at 20-second intervals. If the subject cannot perceive the presence of the tinnitus, a value of zero will be assigned. A typical sound will be presented for 3 to 6 minutes. Loudness will be reported for 1 to 4 minutes after stimulus offset to measure the presence and duration of residual inhibition.

Electrical stimulation will be delivered to the inner ear in three ways, 1. using a cochlear implant (implant placed in the inner ear to replace hearing function), 2. Using an electrode placed in the ear canal, and 3. using a small needle inserted through the ear drum. Various electrical signals will be used to evaluate the reduction in the tinnitus perception by the subject. The subjects will rate the loudness of the tinnitus before, during, and after the electrical signal. Surveys will be used to evaluate the tinnitus loudness and the quality of life of the subjects. Hearing tests will be used before and after the procedures. The long term goal of this research is to develop a device to treat tinnitus in people who can hear and to develop programs for cochlear implants that help treat tinnitus in deaf people.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tinnitus Treatment Using Noninvasive and Minimally Invasive Electric Stimulation: Experimental Design and Feasibility.
   Zeng FG, Richardson M, Tran P, Lin H, et al · · 2019 · cited 10× · PMID 30803416 · DOI 10.1177/2331216518821449
2. Electric hearing and tinnitus suppression by noninvasive ear stimulation.
   Suh MW, Tran P, Richardson M, Sun S, et al · · 2022 · cited 2× · PMID 35016022 · DOI 10.1016/j.heares.2022.108431