Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus

June 25, 2020 updated by: Sarah Theodoroff, VA National Center for Rehabilitative Auditory Research
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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oregon
      • Portland, Oregon, United States, 97239
        • VA Portland Health Care System, National Center for Rehabilitative Auditory Research

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Desyncra
This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.
This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.
Other Names:
  • Desyncra™ for Tinnitus Therapy System
Other: Cognitive Behavioral Therapy
Standard of Care
Standard of Care
Other Names:
  • CBT

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: James Henry (PI), PhD, VA RR&D NCRAR
  • Principal Investigator: Sarah Theodoroff (Co-PI), PhD, VA RR&D NCRAR

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 Major Dates

Study Start

January 1, 2017

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

January 12, 2017

First Posted (Estimate)

January 16, 2017

Study Record Updates

Last Update Posted (Actual)

July 13, 2020

Last Update Submitted That Met QC Criteria

June 25, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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