Randomized Trial Of Tinnitus Retraining Therapy

NCT00578058 | Completed Phase 2 DMC

• 1 other identifier: R01DC005972
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 4

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.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

• Iowa Tinnitus Handicap Questionnaire

  18 months

Secondary Outcomes (1)

• Tinnitus measures

  18 months

Study Arms (6)

1

OTHER

Counseling plus everyday noise type 1

Other: Counseling and Sound Therapy

2

OTHER

Counseling plus static noise type 2

Other: Counseling and Sound Therapy

3

OTHER

Counseling plus static noise type 3

Other: Counseling and Sound Therapy

4

OTHER

Hearing aid and counseling plus everyday noise type 1

Other: Counseling and Sound Therapy

5

OTHER

Hearing aid and counseling plus static noise type 2

Other: Counseling and Sound Therapy

6

OTHER

Hearing aid and counseling plus static noise type 3

Other: Counseling and Sound Therapy

Interventions

Counseling and Sound Therapy OTHER

Tinnitus counseling and sound therapy

1; 2; 3; 4; 5; 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Iowa: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (4)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University at Buffalo, State University of New York

Buffalo, New York, 14214, United States

Location

East Tennessee State University

Johnson City, Tennessee, 37614, United States

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Counseling

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Richard S Tyler, Ph.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 20, 2007
• Study Start: January 1, 2004
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: August 3, 2011

Record last verified: 2011-08

Locations

US (4)