Customized Acoustic Stimulation for the Treatment of Tinnitus

Tinnitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01487447
• Other study ID #: HSMT003 HS# 2006-5187
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: January 2015

Study information

• Verified date: July 2018
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tinnitus

Intervention

Other:
• Customized sound
treatment with customized sound therapy
• Regular Masker
treatment with white noise

Locations

Country	Name	City	State
United States	UC Irvine Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in score of tinnitus loudness		0, 1 minute; 1 hour; 1, 2, 4 and 6 months
Primary	Change in score of tinnitus annoyance		0, 1 minute; 1 hour; 1, 2, 4 and 6 months
Primary	Change in residual inhibition		1 minute; 1 hour; 1, 2, 4 and 6 months
Primary	Change in score of Tinnitus Handicap Inventory (THI)		0, 1, 2, 4 and 6 months