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Evaluation of Treatment Methods for Clinically Significant Tinnitus

Evaluation of Treatment Methods for Clinically Significant Tinnitus

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00013390
Enrollment
200
Registered
2001-03-16
Start date
1999-10-31
Completion date
2002-09-30
Last updated
2011-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus

Keywords

Auditory, tinnitus

Brief summary

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.

Interventions

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).

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.

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients with significant tinnitus

Design outcomes

Primary

MeasureTime frameDescription
Tinnitus Severity IndexBaseline, 3 mo., 6 mo., 12 mo., 18 mo.A well-developed scale currently in use at the Oregon Tinnitus Clinic.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026