Customized Acoustic Stimulation for the Treatment of Tinnitus

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2013 by University of California, Irvine.
Recruitment status was Active, not recruiting

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 (Adult, Senior)
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


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

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 September 27, 2016

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