Overview

This trial is active, not recruiting.

Condition tinnitus
Treatments customized sound, regular masker
Phase phase 2/phase 3
Sponsor University of California, Irvine
Start date January 2010
End date July 2014
Trial size 60 participants
Trial identifier NCT01487447, HSMT003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
customized sound
treatment with customized sound therapy
(Active Comparator)
regular masker
treatment with white noise

Primary Outcomes

Measure
Change in score of tinnitus loudness
time frame: 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
Change in residual inhibition
time frame: 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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by University of California, Irvine.