NCT03022084

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 13, 2020

Completed
Last Updated

July 13, 2020

Status Verified

June 1, 2020

Enrollment Period

2.4 years

First QC Date

January 12, 2017

Results QC Date

June 25, 2020

Last Update Submit

June 25, 2020

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Desyncra

EXPERIMENTAL

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

Device: Desyncra

Cognitive Behavioral Therapy

OTHER

Standard of Care

Other: Cognitive Behavioral Therapy

Interventions

DesyncraDEVICE

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

Also known as: Desyncra™ for Tinnitus Therapy System
Desyncra
Cognitive Behavioral TherapyOTHER

Standard of Care

Also known as: CBT
Cognitive Behavioral Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. James Henry
Organization
VA RR&D National Center for Rehabilitative Auditory Research
James.Henry@va.gov
503-220-8262

Study Officials

  • James Henry (PI), PhD

    VA RR&D NCRAR

    PRINCIPAL INVESTIGATOR

  • Sarah Theodoroff (Co-PI), PhD

    VA RR&D NCRAR

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Investigator

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 16, 2017

Study Start

January 1, 2017

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

July 13, 2020

Results First Posted

July 13, 2020

Record last verified: 2020-06

Locations

US(1)