Tinnitus Clinical Trial
Official title:
Treatment of Tinnitus With Migraine Medications: A Randomized Clinical Trial
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. It is well-understood that many factors, such as poor education, lower income, or occupational, and recreational activity associated with high noise exposure, influences 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, we intend to use medications for patients with tinnitus in order to decrease the impact of tinnitus on their daily life and activities.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 30, 2023 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 85 Years |
Eligibility | Inclusion Criteria: - Patients with moderate to severe tinnitus. - Male or female between the ages of 25 to 85 years. - Subject must be compliant with the medication and attend study visits. - Must be able to read and write in the English language to provide consenting. Exclusion Criteria: - Pregnancy will result in automatic exclusion from the study. Rule out of pregnancy will be done by a urine pregnancy test to confirm the situation for all women who are of child bearing potential. - Subject with history of an adverse reaction to medication being prescribed. - Subject suffers from a medical condition or has history that may be concerning to the investigators clinical opinion. - All contraindications for the medications which prevent subjects from randomization will be considered as exclusion criteria. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Irvine Medical Center ENT Clinic (Pavilion 2) | Orange | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Irvine |
United States,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tinnitus Functional Index (TFI) | Subjective improvement from baseline in tinnitus symptoms as measured by Tinnitus Functional Index (TFI). The TFI is scored from 0% to 100%, with higher scores indicating a more negative impact of tinnitus. | 8 weeks | |
Secondary | Visual Analog Scale (VAS) | Subjective improvement in tinnitus loudness severity based on a visual analog scale (VAS). The VAS is scored from 0 to 10, with a higher score representing an increased severity of tinnitus. | 8 weeks | |
Secondary | Patient Health Questionnaire (PHQ) | Subjective improvement in depression symptoms based on patient health questionnaire (PHQ). The PHQ is scored from 0 to 27, with a higher score indicating increased depression severity. | 8 weeks | |
Secondary | Perceived Stress Scale (PSS) | Subjective improvement in stress based on perceived stress scale (PSS). The PSS is scored from 0 to 40, with higher scores indicating higher perceived stress. | 8 weeks | |
Secondary | Sleep Quality Index (SQI) | Subjective improvement in sleep quality based on sleep quality index (SQI). The SQI is scored from 0 to 21, with higher scores indicating worse quality of sleep. | 8 weeks |
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