Customized Acoustic Stimulation for the Treatment of Tinnitus

January 29, 2020 updated by: University of California, Irvine
The purpose of this study is to determine the efficacy of a customized sound therapy in reducing tinnitus loudness and increasing the residual inhibition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • UC Irvine Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control
Other: Regular Masker
treatment with white noise
EXPERIMENTAL: Intervention
Other: Customized sound
treatment with customized sound therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in score of tinnitus loudness
Time Frame: 0, 1 minute; 1 hour; 1, 2, 4 and 6 months
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
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
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
0, 1, 2, 4 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

December 2, 2011

First Submitted That Met QC Criteria

December 5, 2011

First Posted (ESTIMATE)

December 7, 2011

Study Record Updates

Last Update Posted (ACTUAL)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSMT003 HS# 2006-5187

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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