NCT03511807 Acoustic and Electrical Stimulation for the Treatment of Tinnitus
| NCT ID | NCT03511807 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Irvine |
| Condition | Tinnitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2017-01-01 |
| Primary Completion | 2032-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2017-01-01 with a primary completion date of 2032-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. 18 years or older 2. Male or female 3. Tinnitus present for 6 months or more 4. Adequate command of English to reliably describe the unusual sensory percepts provided by electrical stimulation, and to complete surveys. 5. For patients undergoing electrical stimulation via a cochlear implant, they should have a cochlear implant prior to enrollment (not applicable for acoustic stimulation) Exclusion Criteria: 1. Aged less than 18 years 2. Active illicit drug use, alcohol dependence 3. Treatable cause of tinnitus 4. History of psychosis 5. Abnormalities of the ear canal or ear drum 6. Chronic middle ear disease 7. Subjects on medications known to cause tinnitus (aspirin, ibuprofen, naproxen) which could not be stopped will be excluded. 8. Pregnant or breastfeeding.
Contact & Investigator
Hamid Djalilian, MD
✉ tinnitus@uci.eduHamid Djalilian, MD
PRINCIPAL INVESTIGATOR
University of California, Irvine
Frequently Asked Questions
Who can join the NCT03511807 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tinnitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03511807 currently recruiting?
Yes, NCT03511807 is actively recruiting participants. Contact the research team at tinnitus@uci.edu for enrollment information.
Where is the NCT03511807 trial being conducted?
This trial is being conducted at Irvine, United States.
Who is sponsoring the NCT03511807 clinical trial?
NCT03511807 is sponsored by University of California, Irvine. The principal investigator is Hamid Djalilian, MD at University of California, Irvine. The trial plans to enroll 100 participants.