Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus

Tinnitus Clinical Trial

Official title:

Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03022084
• Other study ID #: PVARF-387005
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: June 2019

Study information

• Verified date: June 2020
• Source: VA National Center for Rehabilitative Auditory Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus

Intervention

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

Other:
• Cognitive Behavioral Therapy
Standard of Care

Locations

Country	Name	City	State
United States	VA Portland Health Care System, National Center for Rehabilitative Auditory Research	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
VA National Center for Rehabilitative Auditory Research	Desyncra, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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