Acoustic and Electrical Stimulation for the Treatment of Tinnitus

Part of paid clinical trials in Irvine, California.

Sponsor
University of California, Irvine
Study ID
NCT03511807
Status
Recruiting
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Conditions

  • Tinnitus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Electrical — OTHER
    For the electrical stimulation: An electrode will be inserted into the ear canal which will be stimulated.
  • Acoustic — OTHER
    For the acoustic stimulation: A typical sound will be presented for 6 minutes. Loudness is reported for 4 minutes after the stimulus offset to measure the presence and duration of the residual inhibition. If a successful acoustic stimulus is found, the subject will be given a series of sound files to listen to on a digital music player (CD or MP3 player) and will be asked to listen to each sound file (5 minute duration) and record their tinnitus loudness/annoyance during and after each sound stimulation. For some subjects, the investigators will use music on a digital music player (MP3 player) to see if music listening and music exercises will help reduce the intensity or annoyance level of the tinnitus (using the same surveys). These music-based exercises will involve training in recognition of musical intervals (e.g., octaves, fifths, and thirds).

Study Details

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 Dates

Start date
Jan 1, 2017
Status verified
Jun 2026
Primary completion
Nov 30, 2032
Completion
Nov 30, 2032

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Electrical/ Acoustic stimulation

Primary Outcome Measure

Audiogram [ Time Frame: Occurs once at the beginning of subject participation (less than one hour) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hamid R. DjalilianIrvineCalifornia92612
William Pu, MS
[email protected]
Amanda Francis, BA
[email protected]

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