Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03022084
Recruitment Status : Completed
First Posted : January 16, 2017
Results First Posted : July 13, 2020
Last Update Posted : July 13, 2020
Sponsor:
Collaborator:
Desyncra, Inc.
Information provided by (Responsible Party):
Sarah Theodoroff, VA National Center for Rehabilitative Auditory Research

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Tinnitus Device: Desyncra Other: Cognitive Behavioral Therapy Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus
Study Start Date : January 2017
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Desyncra
This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.
 Device: Desyncra
This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.
Other Name: Desyncra™ for Tinnitus Therapy System
Cognitive Behavioral Therapy
Standard of Care
 Other: Cognitive Behavioral Therapy
Standard of Care
Other Name: CBT


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022084


Locations
Layout table for location information
United States, Oregon
VA Portland Health Care System, National Center for Rehabilitative Auditory Research
Portland, Oregon, United States, 97239
Sponsors and Collaborators
VA National Center for Rehabilitative Auditory Research
Desyncra, Inc.
Investigators
Layout table for investigator information
Principal Investigator: James Henry (PI), PhD VA RR&D NCRAR
Principal Investigator: Sarah Theodoroff (Co-PI), PhD VA RR&D NCRAR
  Study Documents (Full-Text)

Documents provided by Sarah Theodoroff, VA National Center for Rehabilitative Auditory Research:
Study Protocol and Statistical Analysis Plan  [PDF] March 13, 2018

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Sarah Theodoroff, Research Investigator, VA National Center for Rehabilitative Auditory Research
ClinicalTrials.gov Identifier: NCT03022084    
Other Study ID Numbers: PVARF-387005
First Posted: January 16, 2017    Key Record Dates
Results First Posted: July 13, 2020
Last Update Posted: July 13, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases