Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus

VA National Center for Rehabilitative Auditory Research

Status

Completed

Conditions

Tinnitus

Treatments

Device: Desyncra

Other: Cognitive Behavioral Therapy

Study type

Interventional

Funder types

Other U.S. Federal agency

Other

Identifiers

NCT03022084

PVARF-387005

Details and patient eligibility

About

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.

Full 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.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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