NCT00124800

Brief Summary

The objective of this study is to examine the efficacy of tinnitus retraining therapy (TRT) as a treatment of chronic tinnitus in people with limited hearing loss. The study design is prospective, randomized, double-blind, with repeated measures. The null hypothesis states there will be no difference in subjective measures of tinnitus severity between subjects treated with standard TRT and subjects treated with sham TRT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2005

Typical duration for phase_1

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

September 24, 2009

Status Verified

September 1, 2009

Enrollment Period

3.6 years

First QC Date

July 27, 2005

Last Update Submit

September 23, 2009

Conditions

Tinnitus

Keywords

tinnitus

Outcome Measures

Primary Outcomes (2)

  • Change in objective measure of tinnitus loudness using psychoacoustic matching task

    18 months

  • Change in subjective handicap rating of tinnitus using a standardized questionnaire

    18 months

Secondary Outcomes (1)

  • Change in subjective ratings of tinnitus loudness, annoyance and awareness

    18 months

Interventions

Tinnitus retraining therapyBEHAVIORAL

Sound therapy and counseling

Sound therapyDEVICE

sound therapy and counselling

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic non-pulsatile tinnitus

You may not qualify if:

  • Hyperacusis
  • Subjective hearing loss
  • Objective hearing loss with pure tone average greater than 35 dB sound pressure level (SPL)
  • Evidence of significant depression or suicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Illinois University School of Medicine

Springfield, Illinois, 62794, United States

Location

Related Links

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

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

Study Officials

  • Carol A Bauer, MD

    Southern Illinois University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 27, 2005

First Posted

July 28, 2005

Study Start

November 1, 2005

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

September 24, 2009

Record last verified: 2009-09

Locations

US(1)