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Randomized Trial Of Tinnitus Retraining Therapy

Primary Purpose

Tinnitus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Counseling and Sound Therapy
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have experienced tinnitus for at least 4 months.
  • Have the ability to participate in research.

Exclusion Criteria:

  • Have a treatable otological disorder.
  • Are involved in litigation.
  • Have or are suspected of having a serious psychiatric problem.

Sites / Locations

  • University of Iowa
  • University of Michigan
  • University at Buffalo, State University of New York
  • East Tennessee State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Other

Other

Other

Other

Other

Other

Arm Label

1

2

3

4

5

6

Arm Description

Counseling plus everyday noise type 1

Counseling plus static noise type 2

Counseling plus static noise type 3

Hearing aid and counseling plus everyday noise type 1

Hearing aid and counseling plus static noise type 2

Hearing aid and counseling plus static noise type 3

Outcomes

Primary Outcome Measures

Iowa Tinnitus Handicap Questionnaire

Secondary Outcome Measures

Tinnitus measures

Full Information

First Posted
December 18, 2007
Last Updated
August 2, 2011
Sponsor
University of Iowa
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT00578058
Brief Title
Randomized Trial Of Tinnitus Retraining Therapy
Official Title
Randomized Trial Of Tinnitus Retraining Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Iowa
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Millions of Americans suffer from tinnitus. However, there is no widely accepted treatment that has been shown to be effective in controlled investigations. The purpose of this study is to evaluate the effectiveness of Tinnitus Retraining Therapy (TRT). This study will investigate the contributions of counseling, the use of hearing aids and sound generators, and the importance of setting masking noise to a particular level. All groups will receive the same Counseling. In pilot studies we have developed a picture-based counseling protocol. The results of this study will determine if TRT is more effective than masking or counseling alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Counseling plus everyday noise type 1
Arm Title
2
Arm Type
Other
Arm Description
Counseling plus static noise type 2
Arm Title
3
Arm Type
Other
Arm Description
Counseling plus static noise type 3
Arm Title
4
Arm Type
Other
Arm Description
Hearing aid and counseling plus everyday noise type 1
Arm Title
5
Arm Type
Other
Arm Description
Hearing aid and counseling plus static noise type 2
Arm Title
6
Arm Type
Other
Arm Description
Hearing aid and counseling plus static noise type 3
Intervention Type
Other
Intervention Name(s)
Counseling and Sound Therapy
Intervention Description
Tinnitus counseling and sound therapy
Primary Outcome Measure Information:
Title
Iowa Tinnitus Handicap Questionnaire
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Tinnitus measures
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have experienced tinnitus for at least 4 months. Have the ability to participate in research. Exclusion Criteria: Have a treatable otological disorder. Are involved in litigation. Have or are suspected of having a serious psychiatric problem.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard S Tyler, Ph.D.
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University at Buffalo, State University of New York
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Facility Name
East Tennessee State University
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37614
Country
United States

12. IPD Sharing Statement

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Randomized Trial Of Tinnitus Retraining Therapy

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