Back to resultsCustomized Acoustic Stimulation for the Treatment of Tinnitus
Primary Purpose
Tinnitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Customized sound
Regular Masker
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- Male or female
- Tinnitus present for 6 months or more
- Adequate command of English
Exclusion Criteria:
- Active illicit drug use, alcohol dependence
- Treatable cause of tinnitus
- History of psychosis
- Subjects on medications known to cause tinnitus (aspirin, ibuprofen, naproxen) which could not be stopped will be excluded.
Sites / Locations
- UC Irvine Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
Outcomes
Primary Outcome Measures
Change in score of tinnitus loudness
Change in score of tinnitus annoyance
Change in residual inhibition
Change in score of Tinnitus Handicap Inventory (THI)
Secondary Outcome Measures
Full Information
NCT ID
NCT01487447
First Posted
December 2, 2011
Last Updated
January 29, 2020
Sponsor
University of California, Irvine
1. Study Identification
Unique Protocol Identification Number
NCT01487447
Brief Title
Customized Acoustic Stimulation for the Treatment of Tinnitus
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Irvine
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the efficacy of a customized sound therapy in reducing tinnitus loudness and increasing the residual inhibition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Customized sound
Intervention Description
treatment with customized sound therapy
Intervention Type
Other
Intervention Name(s)
Regular Masker
Intervention Description
treatment with white noise
Primary Outcome Measure Information:
Title
Change in score of tinnitus loudness
Time Frame
0, 1 minute; 1 hour; 1, 2, 4 and 6 months
Title
Change in score of tinnitus annoyance
Time Frame
0, 1 minute; 1 hour; 1, 2, 4 and 6 months
Title
Change in residual inhibition
Time Frame
1 minute; 1 hour; 1, 2, 4 and 6 months
Title
Change in score of Tinnitus Handicap Inventory (THI)
Time Frame
0, 1, 2, 4 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
Male or female
Tinnitus present for 6 months or more
Adequate command of English
Exclusion Criteria:
Active illicit drug use, alcohol dependence
Treatable cause of tinnitus
History of psychosis
Subjects on medications known to cause tinnitus (aspirin, ibuprofen, naproxen) which could not be stopped will be excluded.
Facility Information:
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Customized Acoustic Stimulation for the Treatment of Tinnitus
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