ACTIVE_NOT_RECRUITING

Management of Acute Tinnitus With Migraine Medications

Conditions

Tinnitus Acute tinnitus Atypical migraine ringing in ears

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Management of Acute Tinnitus With Migraine Medications: A Randomized Clinical Trial

Quick Facts

Study Start:2025-06-01

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06799169

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Mehdi Abouzari, MD, PhD

PRINCIPAL_INVESTIGATOR

University of California, Irvine

Study Locations (Sites)

University of California, Irvine Medical Center ENT Clinic (Pavilion 2)

Orange, California, 92868

United States

Collaborators and Investigators

Sponsor: University of California, Irvine

Mehdi Abouzari, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, Irvine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-01

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-06-01

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Tinnitus
Acute tinnitus
Atypical migraine
ringing in ears

Additional Relevant MeSH Terms

Tinnitus