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Customized Acoustic Stimulation for the Treatment of Tinnitus

This study is currently recruiting participants.
Verified December 2011 by University of California, Irvine
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01487447
First received: December 2, 2011
Last updated: December 20, 2011
Last verified: December 2011
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 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487447

Contacts
Contact: Hamid R Djalilian, MD 7144565753 hdjalili@uci.edu

Locations
United States, California
UC Irvine Medical Center Recruiting
Orange, California, United States, 92868
Principal Investigator: Hamid R Djalilian, MD            
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: December 20, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013