Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus

Study Overview
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Brief Summary
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The purpose of this study is to determine if a novel sound-based therapy in comparison to standard of care (cognitive behavioral therapy) results in reducing tinnitus-related effects for people with bothersome tinnitus.

Detailed Description
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This study is a randomized controlled trial evaluating if a customized sound-therapy device is just as effective or more so, than the standard of care (cognitive behavioral therapy, CBT) for bothersome tinnitus. All eligible participants will be randomly assigned to one of the two groups. Depending on group assignment, participants will attend approximately 7-12 visits over a 7-month period.

Official Title
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Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus

Conditions
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Tinnitus

Intervention / Treatment
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* Device: Desyncra
* Other: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Primary and persistent tinnitus (6 months or longer in duration) Tonal tinnitus Dominant tinnitus frequency measured between 0.2 and 10 kHz Tinnitus Questionnaire score No current participation in other tinnitus therapy program Willing and able to listen to the acoustic prescription for 4-6 hours daily during the trial Able to pass the Tone Audibility Assessment with factor of 1.1 Exclusion Criteria: Secondary/somatic tinnitus due to a suspected underlying disease Atonal, pulsatile, intermittent, or occasional tinnitus Any hearing threshold >70 dB HL from .25-8kHz, unless subject passes the Tone Audibility Assessment screening with a factor of 1.1 Any health or other problems that may prevent the person from completing the study procedures as determined by investigator Participant reports current suicidal ideation and/or homicidal ideation Use of medication which may trigger tinnitus [e.g., quinine derivatives, aminoglycoside antibiotics, daily high dose non-steroidal anti-inflammatory drugs ≥1000 mg, salicylates (when not prescribed as a low dose for cardiac health), loop diuretics and chemotherapy agents like cis-platin] Conductive hearing loss Visible congenital or traumatic deformity of the ear History of active drainage from the ear within the past 90 days History of sudden or rapidly progressive hearing loss within the past 90 days Inability to read and respond appropriately to instructions that appear on the computer screen, and/or to perform all of the procedures Previous use of Desyncra for Tinnitus Therapy System

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desyncra<br>This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System. | Device: Desyncra<br>* This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.<br>* Other names: Desyncra™ for Tinnitus Therapy System;|
| Other: Cognitive Behavioral Therapy<br>Standard of Care | Other: Cognitive Behavioral Therapy<br>* Standard of Care<br>* Other names: CBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Questionnaire (TQ) | 52-item questionnaire that measures the functional impact of tinnitus (scores range from 0 to 104); lower scores indicate better outcome | 24-weeks |