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Customized Acoustic Stimulation for the Treatment of Tinnitus

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
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine

Tracking Information
First Submitted Date  ICMJE December 2, 2011
First Posted Date  ICMJE December 7, 2011
Last Update Posted Date January 30, 2020
Study Start Date  ICMJE January 2010
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2011)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 5, 2011)
  • Change in score of tinnitus loudness [ Time Frame: Beofre treatment; 1 minute; 1 hour; 1, 2, 4 and 6 months ]
  • Change in score of tinnitus annoyance [ Time Frame: Beofre treatment; 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: Beofre treatment; 1, 2, 4 and 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Customized Acoustic Stimulation for the Treatment of Tinnitus
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tinnitus
Intervention  ICMJE
  • Other: Customized sound
    treatment with customized sound therapy
  • Other: Regular Masker
    treatment with white noise
Study Arms  ICMJE
  • Experimental: Intervention
    Intervention: Other: Customized sound
  • Active Comparator: Control
    Intervention: Other: Regular Masker
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2018)
31
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2011)
60
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01487447
Other Study ID Numbers  ICMJE HSMT003 HS# 2006-5187
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Irvine
Study Sponsor  ICMJE University of California, Irvine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, Irvine
Verification Date July 2018

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