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Customized Acoustic Stimulation for the Treatment of Tinnitus

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ClinicalTrials.gov Identifier: NCT01487447
Recruitment Status : Unknown
Verified July 2013 by University of California, Irvine.
Recruitment status was:  Active, not recruiting
First Posted : December 7, 2011
Last Update Posted : July 4, 2013
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tinnitus Other: Customized sound Other: Regular Masker Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2010
Estimated Primary Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Other: Customized sound
treatment with customized sound therapy
Active Comparator: Control Other: Regular Masker
treatment with white noise


Outcome Measures
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Primary Outcome Measures :
  1. Change in score of tinnitus loudness [ Time Frame: 0, 1 minute; 1 hour; 1, 2, 4 and 6 months ]
  2. Change in score of tinnitus annoyance [ Time Frame: 0, 1 minute; 1 hour; 1, 2, 4 and 6 months ]
  3. Change in residual inhibition [ Time Frame: 1 minute; 1 hour; 1, 2, 4 and 6 months ]
  4. Change in score of Tinnitus Handicap Inventory (THI) [ Time Frame: 0, 1, 2, 4 and 6 months ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
United States, California
UC Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT01487447     History of Changes
Other Study ID Numbers: HSMT003
First Posted: December 7, 2011    Key Record Dates
Last Update Posted: July 4, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms