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Suspended
NCT06799169
Management of Acute Tinnitus With Migraine Medications
Conditions: Tinnitus
Sex: All
Ages: 25 Years – 85 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 100
Sponsor: University of California, Irvine
Location: University of California, Irvine Medical Center ENT Clinic (Pavilion 2) Orange California
Summary
Tinnitus represents one of the most common and distressing otologic problems, and it causes various somatic and psychological disorders that interfere with the quality of life. Despite too many research projects on finding the mechanism of tinnitus, its pathophysiology remains poorly understood. It is well understood that many factors, such as poor education, lower income, or occupational, and recreational activity associated with high noise exposure, influence the prevalence and risk of tinnitus. Although the economic and emotional impact of tinnitus is large, there is currently no FDA-approved medication to treat this condition. However, there are pharmacological options to address the stress, anxiety, and depression that are caused by tinnitus. In this project, the investigators intend to use medications for patients with acute tinnitus to decrease the impact of tinnitus in their daily lives and activities. There are some studies on medications treating tinnitus; however, there are few randomized clinical trials to prove the efficacy of the treatment. The frequency and loudness of tinnitus will be measured before and after the course. Functional MRI of the brain will be obtained to view any changes that may occur before and after the treatment.
Eligibility Criteria
Inclusion Criteria:
* Patients with mild to moderate tinnitus.
* Male or female between the ages of 25 to 85 years.
* Subjects must be compliant with the medication and attend study visits.
* Must be able to read and write in the English language to provide consent.
Exclusion Criteria:
* Pregnancy will result in automatic exclusion from the study. Rule out of pregnancy will be done by urine pregnancy test to confirm the situation for all women who are of childbearing potential.
* Subjects with a history of an adverse reaction to medication being prescribed.
* Subjects suffering from a medical condition or have a history that may be concerning to the investigator's clinical opinion.
* All contraindications for the medications that prevent subjects from randomization will be considered as exclusion criteria.
Source: ClinicalTrials.gov (NCT06799169). StuddyBuddy aggregates publicly available trial information.