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Acoustic and Electrical Stimulation for the Treatment of Tinnitus

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ClinicalTrials.gov Identifier: NCT03511807
Recruitment Status : Recruiting
First Posted : April 30, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine

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.


Condition or disease Intervention/treatment Phase
Tinnitus Other: Electrical Other: Acoustic Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acoustic and Electrical Stimulation for the Treatment of Tinnitus
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Experimental: Electrical/ Acoustic stimulation Other: Electrical

For the electrical stimulation:

An electrode will be inserted into the ear canal which will be stimulated.


Other: Acoustic

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).





Primary Outcome Measures :
  1. Audiogram [ Time Frame: Occurs once at the beginning of subject participation (less than one hour) ]
    Measures hearing ability in db HL.

  2. Otoacoustic Emissions [ Time Frame: Occurs once at the beginning of subject participation (less than one hour) ]
    Measures health of the inner ear in db HL.

  3. Tinnitus Handicap Inventory [ Time Frame: Outcome will be measured during each participant visit through study completion which can be an average of 1 year ]
    Quantifies and evaluates difficulties experience because of tinnitus measured in a numerical scoreScale range: Yes (value of 4, highest) Sometimes (value of 2) and No (value of 0, lowest). The sum of all responses yields a total THI score (0-100) High scores indicate catastrophic handicap. Low scores indicate slight or no handicap.

  4. Medical Outcomes Study Questionnaire Short Form 36 Health Survey Quality of life metrics. [ Time Frame: Outcome will be measured during each participant visit through study completion which can be an average of 1 year ]
    The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores indicate more disability, higher scores indicate less disability.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511807


Contacts
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Contact: Hamid Djalilian, MD tinnitus@uci.edu
Contact: Sahara George, BA tinnitus@uci.edu

Locations
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United States, California
Hamid R. Djalilian Recruiting
Irvine, California, United States, 92612
Contact: Sahara George, BA    949-824-9107    tinnitus@uci.edu   
Sponsors and Collaborators
University of California, Irvine

Publications:
Feldman H. History of tinnitus research. In: Shulman A, ed. Tinnitus Diagnosis/Treatment. San Diego: Singular Publishing Group; 1997:3-37.
Zwolan TA, Kileny PR, Souliere CR, Kemink JL. Tinnitus suppression following cochlear implantation. In: Aran J-M, Dauman R, eds. Tinnitus 91: Proceedings of the Fourth International Tinnitus Seminar. Amsterdam: Kugler, 1992;423-6.

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Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT03511807     History of Changes
Other Study ID Numbers: 2006-5187
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms