Customized Acoustic Stimulation for the Treatment of Tinnitus
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01487447 |
Recruitment Status :
Completed
First Posted : December 7, 2011
Last Update Posted : January 30, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tinnitus | Other: Customized sound Other: Regular Masker | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 31 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | January 2015 |
Actual Study Completion Date : | January 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: Intervention |
Other: Customized sound
treatment with customized sound therapy |
Active Comparator: Control |
Other: Regular Masker
treatment with white noise |
- Change in score of tinnitus loudness [ Time Frame: 0, 1 minute; 1 hour; 1, 2, 4 and 6 months ]
- Change in score of tinnitus annoyance [ Time Frame: 0, 1 minute; 1 hour; 1, 2, 4 and 6 months ]
- Change in residual inhibition [ Time Frame: 1 minute; 1 hour; 1, 2, 4 and 6 months ]
- Change in score of Tinnitus Handicap Inventory (THI) [ Time Frame: 0, 1, 2, 4 and 6 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01487447
United States, California | |
UC Irvine Medical Center | |
Orange, California, United States, 92868 |
Responsible Party: | University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT01487447 |
Other Study ID Numbers: |
HSMT003 HS# 2006-5187 |
First Posted: | December 7, 2011 Key Record Dates |
Last Update Posted: | January 30, 2020 |
Last Verified: | July 2018 |
Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases |