The Effect of Tinnitus Retraining Therapy on Subjective a... | NCT00124800

Studies
The Effect of Tinnitus Retraining Therapy on Subjective and Objective Measures of Chronic Tinnitus

NCT00124800

Sponsor

Tinnitus Research Consortium

Status

Completed

Last Update Posted

Sep 24, 2009Estimated

Enrollment

41Actual

Phase

Phase 1

Conditions

Tinnitus

Interventions

Tinnitus retraining therapy
Sound therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Jul 27, 2005

First Submission Date that Met QC Criteria

Jul 27, 2005

First Posted Date

Jul 28, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2009

Last Update Posted Date

Sep 24, 2009Estimated

Description Module

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.

Detailed Description

The specific aims of the study are to:

Evaluate the efficacy of TRT in reducing the objective magnitude of tinnitus.
Evaluate the efficacy of TRT in reducing the subjective awareness and impact of tinnitus.
Determine the therapeutic time course of improvement in tinnitus.
Determine the long-term improvement in tinnitus derived from TRT.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tinnitus retraining therapy	Behavioral	Sound therapy and counseling
Sound therapy	Device	sound therapy and counselling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change in subjective ratings of tinnitus loudness, annoyance and awareness		18 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic non-pulsatile tinnitus

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carol A Bauer, MD	Southern Illinois University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southern Illinois University School of Medicine		Springfield	Illinois	62794	United States

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D014012	Tinnitus

Ancestor Terms

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders

Browse Leaves

Not provided

Browse Branches

Not provided