Customized Acoustic Stimulation for the Treatment of Tinnitus

Not Applicable

Completed

• Conditions: Tinnitus
• Interventions: Other: Regular Masker; Other: Customized sound

• Registration Number: NCT01487447
• Lead Sponsor: University of California, Irvine

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 available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-12-02
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-07
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2018-07
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	Regular Masker	-
Intervention	Customized sound	-

Primary Outcome Measures

Name	Time	Method
Change in score of tinnitus loudness	0, 1 minute; 1 hour; 1, 2, 4 and 6 months
Change in score of tinnitus annoyance	0, 1 minute; 1 hour; 1, 2, 4 and 6 months
Change in residual inhibition	1 minute; 1 hour; 1, 2, 4 and 6 months
Change in score of Tinnitus Handicap Inventory (THI)	0, 1, 2, 4 and 6 months

Trial Locations

Locations (1)

UC Irvine Medical Center; 🇺🇸 Orange, California, United States