Tinnitus Research Study
What is Tinnitus?
Tinnitus is the perception of sound in the absence of an environmental stimulus. The sound can be ringing, constant tone, roaring, machine-like or hissing. The sound can always be present or it may come and go. For a more detailed and complete description of tinnitus, go to UCI Tinnitus.
Our Purpose:
Our goal is to identify and deliver an effective and low-cost means of completely suppressing tinnitus via custom and patterned electric stimulation delivered through an external non-invasive device.
Description of Study:
After meeting the inclusion criteria, participants will complete the Tinnitus Handicap Questionnaire and the UCI Tinnitus Survey. Their tinnitus will then be matched to external stimuli with respect to loudness and pitch. The participants will then be familiarized with a loudness ranging scale in order to later report the level of tinnitus prior to any acoustic or electric presentation. The stimulus will be presented non-invasively, and the subject will be instructed to make independent reports of loudness. A typical sound will be presented for 3 to 6 minutes, and loudness will be reported for 1 to 4 minutes after the stimulus is turned off. . Should an effective sound be found, a sound file as long as 10 hours will be created and downloaded to an MP3 player or an Ipod to study the long-term suppression effect.
Eligibility Criteria:
Inclusion Requirements
You are eligible to
participate in this study if
- You are at least 18 years of age
or older,
- You have been clinically diagnosed
with tinnitus and have had it for at least 6 months
- You are able to read English and
describe sounds in English
Exclusion Requirements
You are not eligible
to participate in this study if
- You are not at least 18 years of
age or older
- You are taking medications that
are known to cause tinnitus (such as aspirin, ibuprofen, or naproxen) and
are unable to stop them
- You use illicit drugs or have
alcoholism
- You have a treatable cause of
tinnitus
- You have a history of a
psychiatric condition (depression, anxiety, psychotic disorder, etc.) for which
you have taken medication for at least 6 months
- You have active ear infections,
chronic middle ear disease or any abnormality of the ear canal or ear drum
Three Phases:
There will be three phases to this study, and will involve the testing of
- Subjects with normal hearing and continuous unilateral tinnitus
- Subjects with normal hearing and continuous bilateral tinnitus
- Subjects with hearing loss and any of tinnitus
Benefits:
The
possible benefits you may
experience from the procedures described in this study include reducing or
possibly eliminating your tinnitus temporarily.
Risks:
The possible risks and/or discomforts associated with the procedures described in this study include but are not limited to the lack of improvement in your condition, the worsening of your condition and the inability to maintain the benefit achieved in the procedure. Additionally, there is not a device that is currently available that will be able to deliver the stimulus in a continuous fashion other than the external MP3 player and Ipod described above. Therefore, this is not a long-term treatment option as of yet. Additionally, this is not a cure for the disease.
Time Commitment:
This study will include up to 125 recruited subjects and will involve a minimum of 18 hours and a maximum of 39 hours of your time over the next 3-6 months.
Location(s):
The
Principal Investigator:
Hamid Djalilian, M.D.
Contact Name:
Abby Copeland
Contact Phone:
949-824-9107
Contact
Email:
acopelan@uci.edu
Investigational Review Board (IRB) and Informed Consent:
The study has been approved by the IRB whose role is to protect participants in investigational studies. All patients will be required to read, understand and sign an informed consent prior to participation. All questions and concerns will be addressed with each individual patient prior to the start of any study.
