NCT01487447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 30, 2020

Status Verified

July 1, 2018

Enrollment Period

5 years

First QC Date

December 2, 2011

Last Update Submit

January 29, 2020

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL
Other: Customized sound

Control

ACTIVE COMPARATOR
Other: Regular Masker

Interventions

Customized soundOTHER

treatment with customized sound therapy

Intervention
Regular MaskerOTHER

treatment with white noise

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Male or female
  • Tinnitus present for 6 months or more
  • Adequate command of English

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2011

First Posted

December 7, 2011

Study Start

January 1, 2010

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 30, 2020

Record last verified: 2018-07

Locations

US(1)