Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of Treatment Methods for Clinically Significant Tinnitus

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00013390
First received: March 14, 2001
Last updated: May 17, 2011
Last verified: May 2011

March 14, 2001
May 17, 2011
October 1999
September 2002   (final data collection date for primary outcome measure)
Tinnitus Severity Index [ Time Frame: Baseline, 3 mo., 6 mo., 12 mo., 18 mo. ] [ Designated as safety issue: No ]
A well-developed scale currently in use at the Oregon Tinnitus Clinic.
Not Provided
Complete list of historical versions of study NCT00013390 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of Treatment Methods for Clinically Significant Tinnitus
Evaluation of Treatment Methods for Clinically Significant Tinnitus

The investigators propose to evaluate two different approaches to the alleviation of tinnitus symptoms by comparing changes from baseline performance on the Tinnitus Severity Index. They propose to provide an unbiased evaluation of competing methodologies. The design is one in which pairs of prospective subjects are randomly assigned to one of two treatment groups. Changes in group performance will be compared for selected measures.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Tinnitus
  • Procedure: Tinnitus Masking
    Tinnitus Masking is a widely-used method for providing relief of tinnitus. The central premise of Tinnitus Masking involves the use of wearable ear-level devices (hearing aids, maskers, or combination instruments) that deliver sound to a patient's ear(s). The primary purpose of the sound presentation is to produce a sense of relief from the annoyance caused by the tinnitus sound. The relief is accomplished by either obscuring, or "covering up" (masking) the tinnitus sound, or by changing the sound of the tinnitus in some way, usually by reducing its loudness (Vernon, Meikle).
  • Procedure: Tinnitus Retraining Therapy
    Tinnitus Retraining Therapy (TRT) was derived from a purely psychological approach for facilitating tinnitus habituation (Hallam et al). The current method is based on neurophysiological principles, and aims at "retraining" brain regions that are involved in processing the tinnitus signal, without attempting to suppress generation of the signal (Jastreboff). The retraining involves a systematic effort aimed at decreasing both the detectability of tinnitus and the transmission of the tinnitus "signal" to emotional centers of the brain. Habituation of tinnitus thus purportedly occurs at two levels: habituation of emotional reactions to the tinnitus and habituation of tinnitus perception. Habituation is achieved by utilizing directive counseling, along with the use of low-level broadband noise to reduce the detectability of tinnitus for patients with normal or near-normal hearing. When hearing loss is a significant problem to the patient, appropriate hearing aids are fitted.
    Other Name: TRT
  • Active Comparator: 1
    Tinnitus Masking
    Intervention: Procedure: Tinnitus Masking
  • 2
    Tinnitus Retraining Therapy
    Intervention: Procedure: Tinnitus Retraining Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
September 2002
September 2002   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients with significant tinnitus

Exclusion Criteria:

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00013390
C1995R
No
Henry, James - Principal Investigator, Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: James Henry, PhD VA Medical Center, Portland
Department of Veterans Affairs
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP