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

December 2, 2011
July 3, 2013
January 2010
July 2014   (final data collection date for primary outcome measure)
  • 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 ]
  • Change in score of tinnitus loudness [ Time Frame: Beofre treatment; 1 minute; 1 hour; 1, 2, 4 and 6 months ] [ Designated as safety issue: No ]
  • Change in score of tinnitus annoyance [ Time Frame: Beofre treatment; 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: Beofre treatment; 1, 2, 4 and 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01487447 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Customized Acoustic Stimulation for the Treatment of Tinnitus
Not Provided

The purpose of this study is to determine the efficacy of a customized sound therapy in reducing tinnitus loudness and increasing the residual inhibition.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Tinnitus
  • Other: Customized sound
    treatment with customized sound therapy
  • Other: Regular Masker
    treatment with white noise
  • Experimental: Intervention
    Intervention: Other: Customized sound
  • Active Comparator: Control
    Intervention: Other: Regular Masker
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
Not Provided
July 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01487447
HSMT003
Not Provided
University of California, Irvine
University of California, Irvine
Not Provided
Not Provided
University of California, Irvine
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP