Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus

NCT ID: NCT03022084

Last Updated: 2020-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-06-30

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.

Conditions

Tinnitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Desyncra

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

Group Type: EXPERIMENTAL

Desyncra

Intervention Type: DEVICE

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

Cognitive Behavioral Therapy

Standard of Care

Group Type: OTHER

Cognitive Behavioral Therapy

Intervention Type: OTHER

Standard of Care

Interventions

Desyncra

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

Intervention Type: DEVICE

Cognitive Behavioral Therapy

Standard of Care

Intervention Type: OTHER

Other Intervention Names

Desyncra™ for Tinnitus Therapy System; CBT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Desyncra, Inc.

INDUSTRY

Sponsor Role: collaborator

VA National Center for Rehabilitative Auditory Research

FED

Sponsor Role: lead

Responsible Party

Sarah Theodoroff

Research Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Henry (PI), PhD

Role: PRINCIPAL_INVESTIGATOR

VA RR&D NCRAR

Sarah Theodoroff (Co-PI), PhD

Role: PRINCIPAL_INVESTIGATOR

VA RR&D NCRAR

Locations

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

Portland, Oregon, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PVARF-387005

Identifier Type: -

Identifier Source: org_study_id