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Customized Acoustic Stimulation for the Treatment of Tinnitus

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ClinicalTrials.gov Identifier: NCT01487447
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : January 30, 2020
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 Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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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
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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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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
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases