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Customized Acoustic Stimulation for the Treatment of Tinnitus

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01487447
First received: December 2, 2011
Last updated: July 3, 2013
Last verified: July 2013
History of Changes
  Purpose

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 Intervention Phase
Tinnitus
 Other: Customized sound
Other: Regular Masker
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus
U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Change in score of tinnitus loudness [ Time Frame: 0, 1 minute; 1 hour; 1, 2, 4 and 6 months ] [ Designated as safety issue: No ]
  • Change in score of tinnitus annoyance [ Time Frame: 0, 1 minute; 1 hour; 1, 2, 4 and 6 months ] [ Designated as safety issue: No ]
  • Change in residual inhibition [ Time Frame: 1 minute; 1 hour; 1, 2, 4 and 6 months ] [ Designated as safety issue: No ]
  • Change in score of Tinnitus Handicap Inventory (THI) [ Time Frame: 0, 1, 2, 4 and 6 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 60
Study Start Date: January 2010
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Other: Customized sound
treatment with customized sound therapy
Active Comparator: Control Other: Regular Masker
treatment with white noise

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487447

Locations
United States, California
UC Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
  More Information

No publications provided

Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT01487447     History of Changes
Other Study ID Numbers: HSMT003
Study First Received: December 2, 2011
Last Updated: July 3, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on March 03, 2015