Acoustic and Electrical Stimulation for the Treatment of Tinnitus

Recruiting now · Not applicable

Conditions studied: Tinnitus

In brief

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.

Key facts

Study ID

NCT03511807

Run by

University of California, Irvine

People needed

100

Starts

2017-01-01

Expected to finish

2032-11-01

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 years or older
• Male or female
• Tinnitus present for 6 months or more
• Adequate command of English to reliably describe the unusual sensory percepts provided by electrical stimulation, and to complete surveys.
• For patients undergoing electrical stimulation via a cochlear implant, they should have a cochlear implant prior to enrollment (not applicable for acoustic stimulation)

You may not qualify if…

• Aged less than 18 years
• Active illicit drug use, alcohol dependence
• Treatable cause of tinnitus
• History of psychosis
• Abnormalities of the ear canal or ear drum
• Chronic middle ear disease
• Subjects on medications known to cause tinnitus (aspirin, ibuprofen, naproxen) which could not be stopped will be excluded.
• Pregnant or breastfeeding.

Where it is running

• Hamid R. Djalilian — Irvine, California, United States (enrolling)

Full record on ClinicalTrials.gov

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