- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03022084
Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus
June 25, 2020 updated by: Sarah Theodoroff, VA National Center for Rehabilitative Auditory Research
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
61
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Oregon
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Portland, Oregon, United States, 97239
- VA Portland Health Care System, National Center for Rehabilitative Auditory Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Desyncra
This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.
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This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.
Other Names:
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Other: Cognitive Behavioral Therapy
Standard of Care
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Standard of Care
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tinnitus Questionnaire (TQ)
Time Frame: 24-weeks
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52-item questionnaire that measures the functional impact of tinnitus (scores range from 0 to 104); lower scores indicate better outcome
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24-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: James Henry (PI), PhD, VA RR&D NCRAR
- Principal Investigator: Sarah Theodoroff (Co-PI), PhD, VA RR&D NCRAR
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2017
Primary Completion (Actual)
June 1, 2019
Study Completion (Actual)
June 1, 2019
Study Registration Dates
First Submitted
January 12, 2017
First Submitted That Met QC Criteria
January 12, 2017
First Posted (Estimate)
January 16, 2017
Study Record Updates
Last Update Posted (Actual)
July 13, 2020
Last Update Submitted That Met QC Criteria
June 25, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PVARF-387005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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