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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Electrical/ Acoustic stimulation||
For the electrical stimulation:
An electrode will be inserted into the ear canal which will be stimulated.
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).
- Audiogram [ Time Frame: Occurs once at the beginning of subject participation (less than one hour) ]Measures hearing ability in db HL.
- 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.
- 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.
- 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.
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
|Contact: Hamid Djalilian, MDemail@example.com|
|Contact: Sahara George, BAfirstname.lastname@example.org|
|United States, California|
|Hamid R. Djalilian||Recruiting|
|Irvine, California, United States, 92612|
|Contact: Sahara George, BA 949-824-9107 email@example.com|