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.
This study is 8-weeks in duration. There are two arms in the experiment: the first is nortriptyline (7.5 mg) plus topiramate (10 mg), the second is verapamil (240 mg) plus paroxetine (32 mg). This is a double-blinded trial. Participants will be randomized to one arm for the duration of the trial using simple randomization with a computer-generated number. Both groups may receive dosage increases weekly if symptoms do not improve. Symptomatic survey scores from each arm will be obtained before and after treatment and weekly. An unblinded clinical researcher will also become involved with patients\' treatments as they start to report changes in symptoms in order to monitor their safety and provide advice on change in dosage if patients have questions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Nortriptyline (7.5 mg) plus Topiramate (10 mg) taken by mouth daily with appropriate dosage increase as necessary
Nortriptyline (7.5 mg) plus Topiramate (10 mg) taken by mouth daily with appropriate dosage increase as necessary
Verapamil (30 mg) plus Paroxetine (4 mg) taken by mouth daily with appropriate dosage increase as necessary
Verapamil (30 mg) plus Paroxetine (4 mg) taken by mouth daily with appropriate dosage increase as necessary
University of California, Irvine Medical Center ENT Clinic (Pavilion 2)
Orange, California, United States
Tinnitus Functional Index
The primary outcome endpoint is a Tinnitus Functional Index (TFI) score which comprehensively evaluates the negative impact of tinnitus across 8 domains each focusing on specific dimensions: Intrusive, Sense of control, Cognitive, Sleep, Auditory, Relaxation, Quality of life, and Emotional. The overall score ranges from 0 to 100. Changes 13 points in TFI are the Minimal Clinically Important Difference (MCID). 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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
Perceived Stress Scale (PSS)
Perceived Stress Scale (PSS) \[Time Frame: 8 weeks\] 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.
Time frame: 8 weeks
Patient Health Questionnaire (PHQ-9)
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.
Time frame: 8 weeks
Pittsburgh Sleep Quality Index (PSQI)
Subjective improvement in sleep quality based on sleep quality index (PSQI). The PSQI is scored from 0 to 21, with higher scores indicating worse quality of sleep.
Time frame: 8 weeks
Generalized Anxiety Disorder (GAD-7)
Subjective improvement in generalized anxiety based on general anxiety disorder (GAD-7). The GAD-7 is scored from 0 to 21, with higher scores indicating increased anxiety severity.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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