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Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Desyncra
Cognitive Behavioral Therapy
Sponsored by
VA National Center for Rehabilitative Auditory Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Portland Health Care System, National Center for Rehabilitative Auditory Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Desyncra

Cognitive Behavioral Therapy

Arm Description

This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.

Standard of Care

Outcomes

Primary Outcome Measures

Tinnitus Questionnaire (TQ)
52-item questionnaire that measures the functional impact of tinnitus (scores range from 0 to 104); lower scores indicate better outcome

Secondary Outcome Measures

Full Information

First Posted
January 12, 2017
Last Updated
June 25, 2020
Sponsor
VA National Center for Rehabilitative Auditory Research
Collaborators
Desyncra, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03022084
Brief Title
Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus
Official Title
Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA National Center for Rehabilitative Auditory Research
Collaborators
Desyncra, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desyncra
Arm Type
Experimental
Arm Description
This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.
Arm Title
Cognitive Behavioral Therapy
Arm Type
Other
Arm Description
Standard of Care
Intervention Type
Device
Intervention Name(s)
Desyncra
Other Intervention Name(s)
Desyncra™ for Tinnitus Therapy System
Intervention Description
This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.
Intervention Type
Other
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
CBT
Intervention Description
Standard of Care
Primary Outcome Measure Information:
Title
Tinnitus Questionnaire (TQ)
Description
52-item questionnaire that measures the functional impact of tinnitus (scores range from 0 to 104); lower scores indicate better outcome
Time Frame
24-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Henry (PI), PhD
Organizational Affiliation
VA RR&D NCRAR
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sarah Theodoroff (Co-PI), PhD
Organizational Affiliation
VA RR&D NCRAR
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System, National Center for Rehabilitative Auditory Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus

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