Tinnitus Retraining Therapy Trial - Full Text View

Sponsor:	Johns Hopkins Bloomberg School of Public Health
Collaborators:	National Institute on Deafness and Other Communication Disorders (NIDCD) University of Alabama, Tuscaloosa David Grant U.S. Air Force Medical Center Wilford Hall Medical Center United States Naval Medical Center, San Diego United States Naval Medical Center, Portsmouth National Naval Medical Center Naval Hospital Camp Pendleton
Information provided by (Responsible Party):	Roberta Scherer, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:	NCT01177137

Purpose

The primary purpose of the Tinnitus Retraining Therapy Trial (TRTT) is to assess the efficacy of tinnitus retraining therapy (TRT) as a treatment for severe debilitating tinnitus. TRT is a non-medical intervention that uses directive counseling (DC) and sound therapy (ST)to habituate the patient's associated negative emotional reactions to tinnitus, its perception, and ultimately, its impact on the patient's life.

Condition	Intervention	Phase
Subjective Tinnitus	Device: Conventional sound generator (SG) Device: Placebo sound generator (placebo SG) Behavioral: Standard of Care (SC) Behavioral: Directive Counseling (DC)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Tinnitus Retraining Therapy Trial

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus

U.S. FDA Resources

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:

Change in score on the Tinnitus Questionnaire (TQ) [ Time Frame: Baseline to 3, 6, 12, and 18 months follow-up ] [ Designated as safety issue: No ]
Initial TQ administration will determine eligibility (score greater than or equal to 40) for the TRTT. The primary outcome is a repeated measures analysis of change in TQ score from baseline to follow-up.

Secondary Outcome Measures:

Change in TQ sub-scale scores [ Time Frame: Baseline to 3, 6, 12, and 18 months follow-up ] [ Designated as safety issue: No ]
Repeated measures analysis of change in sub-scale scores from baseline to follow-up. Sub-scales include the following: psychological distress, intrusiveness, hearing difficulties, sleep disturbances, and somatic complaints.
Change in Tinnitus Handicap Inventory (THI) score [ Time Frame: Baseline to 3, 6, 12, and 18 months follow-up ] [ Designated as safety issue: No ]
Repeated measures analysis of change in overall and sub-scale scores from baseline to follow-up. Subscales include the following: functional, emotional; and catastrophic.
Change in Tinnitus Functional Index (TFI) score [ Time Frame: Baseline to 3, 6, 12, and 18 months follow-up ] [ Designated as safety issue: No ]
Repeated measures of change from baseline to follow-up in health related quality of life domains affected by tinnitus. Domains include intrusiveness, reduced sense of control, cognitive interference, sleep disturbance, auditory difficulties (related to tinnitus), relaxation interference, reduced quality of life, and emotional distress.
Change in TRT Interview Visual Analogue scales [ Time Frame: Baseline to 3, 6, 12, and 18 months follow-up ] [ Designated as safety issue: No ]
Repeated measures analysis of change in score from baseline to follow-up.
Change in Digit Symbol Substitution Test (DSST) [ Time Frame: Baseline to 6 and 18 months follow-up ] [ Designated as safety issue: No ]
Repeated measures analysis of change in score from baseline to follow-up. This test assesses cognitive function related to ability to focus attention to a task and recall and is an indirect measure of ability to ignore the tinnitus signal.
Change in psychoacoustic variables [ Time Frame: Baseline to 6 and 18 months follow-up ] [ Designated as safety issue: No ]
Repeated measures analysis of change from baseline to follow-up in tinnitus pitch and loudness match and loudness discomfort level.
Hearing Handicap Inventory (HHI) [ Time Frame: Before randomized treatment assignment is requested to 6 and 18 months follow-up ] [ Designated as safety issue: No ]
The HHI is a measure of the impact of hearing difficulties on the quality of life.

Estimated Enrollment:	228
Study Start Date:	July 2011
Estimated Study Completion Date:	February 2015
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: TRT TRT includes treatment with a conventional sound generator (SG) and directive counseling (DC)	Device: Conventional sound generator (SG) Conventional SGs: Tranquil model sound generators (General Hearing Instruments, Inc.) are outside-the-ear devices that generate low-level noise, which is set at or just below the patient's mixing point (i.e., the noise level that just blends with the study participant's tinnitus) Behavioral: Directive Counseling (DC) Directive Counseling (DC): two-hour educational session during which the patient is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, provide instruction on anatomy and physiology of hearing and tinnitus, introduce the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and describe and recommend the use of ST and environmental sound in the habituation process.
Partial TRT Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC).	Device: Placebo sound generator (placebo SG) Tranquil model placebo sound generators (General Hearing Instruments, Inc.) are outside-the-ear devices that generate a sound different from the active devices. Behavioral: Directive Counseling (DC) Directive Counseling (DC): two-hour educational session during which the patient is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, provide instruction on anatomy and physiology of hearing and tinnitus, introduce the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and describe and recommend the use of ST and environmental sound in the habituation process.
Standard of Care (SC) The standard of care arm includes care as typically delivered in US military medical centers	Behavioral: Standard of Care (SC) The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.

Detailed Description:

The Tinnitus Retraining Therapy Trial (TRTT), funded by the National Institute of Deafness and Other Communication Disorders, is a multi-center randomized clinical trial testing the efficacy of tinnitus retraining therapy (TRT) versus standard-of-care (SC) treatment in individuals who have self-perceived intolerable tinnitus. TRT is a non-medical intervention that uses directive counseling (DC) and low-level sound therapy (ST) achieved through sound generators (SGs) to habituate the patient's associated negative emotional reactions (annoyance) to tinnitus, its perception (awareness) and, ultimately, its impact on the participant's life. Study participants will include active and retired military personnel of the U. S. Armed Forces and their dependents who suffer from severe tinnitus. The study will be conducted at flagship Air Force, and Navy Medical Centers.

This trial will evaluate the efficacy of TRT and its components (DC and ST) versus the standard of care (SC) as administered in the military by comparing the efficacy of:

(1) TRT (DC and ST achieved using conventional sound generators) versus SC;
(2) TRT versus partial TRT (DC and placebo sound generators) to evaluate the separate effect of sound therapy, under the assumption that placebo noise generator will not provide any meaningful sound therapy beyond that found in SC;
(3) partial TRT versus SC to evaluate the separate effect of DC.

Eligibility will be determined at the Baseline Eligibility Visit, which will consist of a medical and tinnitus history, physical examination, and baseline audiological/tinnitus/hyperacusis evaluation. Study participants will also complete a series of quality of life and psychological profile tests. Study Audiologists will administer the randomly assigned treatment. Follow-up visits at Clinical Centers will take place at 3, 6, 12, and 18 months and include completion of tinnitus outcome questionnaires at all visits. Psychometric testing and audiological/tinnitus/hyperacusis evaluation will take place at the 6, 12, and 18 month visits. Evaluation of audiometric pure tone and loudness discomfort level also will take place at treatment visits.

The primary outcome to be measured in the TRTT will be change in scores on the Tinnitus Questionnaire (TQ) longitudinally assessed between baseline and follow-up (i.e., at 3, 6, 12 and 18 months following treatment). Secondary outcomes include changes in the sub-scales of the TQ, change in scores from the Tinnitus Handicap Inventory (THI), Tinnitus Functional Index (TFI), Hearing Handicap Inventory (HHI), and TRT visual analogue scales, and change in the Digit Symbol Substitution Test (DSST). Psychometric secondary outcomes also include change in psychoacoustic variables related to the tinnitus sensation, including tinnitus pitch and loudness match, and loudness discomfort level.

The TRTT is designed to have sufficient power to detect a minimal clinically important difference in the Tinnitus Questionnaire (TQ) i.e., a 10 point difference between TRT and SC groups on change in TQ global scores longitudinally assessed over the course of follow-up and a 7-point difference on TQ score by TRT components, DC and ST.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18 years or above
Subjective severe tinnitus, defined as a score on the Tinnitus Questionnaire (TQ) greater than or equal to 40
Eligible for care at a Department of Defense Clinical Center
Speaks English well enough to complete a series of questionnaires and benefit from counseling

Exclusion Criteria:

Involvement in pending tinnitus-related financial claims or litigation except that associated with usual Veterans' Administration retirement claims
Tinnitus of less than 12 months duration
Treatment for tinnitus within previous 12 months
Routine unavoidable exposure to hazardous noise
Use of a cancer chemotherapeutic drug within previous 12 months
Treatment for head or neck injury within previous 24 months
Treatment for an emotional, psychological, or psychiatric condition within previous 12 months resulting in inability to participate in the trial or complete all followup visits, as assessed by best clinical judgment
Requirement for use of an ototoxic drug
Hearing impairment, defined by audiometric thresholds > 30 dB HL at and below 2,000 Hz and > 40 dB HL at 4,000 and 8,000 Hz
Required use of hearing aids
Fluctuating hearing loss at a level that would interfere with the reliability of study results
One or more prominent spontaneous otoacoustic emissions, defined as the presence of a spontaneous otoacoustic emission spike that is 3 or more times larger than the measured variation in amplitude across the remaining frequency range and/or if the emission corresponds in pitch to the tinnitus pitch
Pulsatile somatosounds suggesting presence of abnormal vasculature or high blood pressure contributing to the tinnitus
Feigning tinnitus or hearing loss
Evidence by audiological testing of a treatable etiology of the tinnitus, such as conductive hearing impairment as shown by pure-tone thresholds, abnormal acoustic immittance, abnormal stapedial reflex test, or abnormal auditory brainstem response
Predisposing disease with tinnitus symptoms amenable to medical or surgical intervention, including but not limited to; chronic otitis media, otosclerosis, vestibular disorder or dizziness, Eustachian tube, middle ear, or inner ear disease, Lyme disease or ear autoimmune disease, malocclusion or temporomandibular joint disease, uncontrolled allergies, aberrant ear, head, or neck blood vasculature or glomus tumor, neurological condition such as multiple sclerosis or ear-related demyelinating disease, perilymphatic fistula, or facial weakness or paralysis
Meniere's disease
Uncontrolled diabetes, defined as blood glucose consistently ≥ 200 mg/dl or an HBA1c above 8%
Evidence from any laboratory study that suggests an etiology for the tinnitus that is treatable, including, but not limited to, abnormal thyroid stimulating hormone (TSH) or thyroid hormone (T3 or T4) levels, positive fluorescent treponemal antibody (FTA) test, or positive Lyme titer
Evidence of a tumor contributing to the tinnitus, including an acoustic neuroma (or vestibular schwannoma), cerebellopontine angle tumor, skull base tumor, or any other type of tumor that the examining physician believes is responsible for the tinnitus
Diagnosis of traumatic head or brain injury requiring treatment
Diagnosis of an emotional, psychological, or psychiatric condition requiring treatment and resulting in inability to participate in the trial or complete all followup visits, as assessed by best clinical judgment
Inability or unwillingness of patient to comply with study requirements
Unwillingness of Clinical Center Director to randomize the patient to treatment due to the presence of any condition, physical, mental or social, which is likely to affect the patient returning for follow-up visits on schedule or which is likely to impair his or her performance on the functional tests
Inability or unwillingness of patient to provide informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177137

Contacts

Contact: Roberta W. Scherer, PhD

(410) 502-4636

rscherer@jhsph.edu

Locations

United States, California
Naval Hospital Camp Pendleton	Recruiting
Camp Pendleton, California, United States, 92055-5191
Contact: Shawna Lee, AuD 760-725-1641 shawna.lee@med.navy.mil
Principal Investigator: Priscilla George, AuD
Naval Medical Center	Recruiting
San Diego, California, United States, 92134
Contact: Robert Olsson, AuD 619-892-3500 bob@rjolsson.com
Principal Investigator: Cynthia Kirby, AuD
David Grant Medical Center	Recruiting
Travis AFB, California, United States, 94535
Contact: Keva Simmons 707-423-7157 keva.simmons.1.ctr@us.af.mil
Principal Investigator: Cynthia Eades, MS
United States, Maryland
National Naval Medical Hospital	Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: Shoshannah Kantor 802-272-8889 shoshannah.kantor@gmail.com
Principal Investigator: Michele Spencer, AuD
United States, Texas
Wilford Hall Medical Center	Recruiting
Lackland AFB, Texas, United States, 78236-5300
Contact: Mark Sullivan 210-292-7937 mark.sullivan.6@us.af.mil
Principal Investigator: Ben Sierra-Irizarry, AuD
United States, Virginia
Portsmouth Naval Medical Center	Recruiting
Portsmouth, Virginia, United States, 23705-2103
Contact: Krezia Del Rosario 757-953-3674 krizia.delrosario.ctr@med.navy.mil
Principal Investigator: Virginia Teti, MD

Sponsors and Collaborators

Johns Hopkins Bloomberg School of Public Health

National Institute on Deafness and Other Communication Disorders (NIDCD)

University of Alabama, Tuscaloosa

David Grant U.S. Air Force Medical Center

Wilford Hall Medical Center

United States Naval Medical Center, San Diego

United States Naval Medical Center, Portsmouth

National Naval Medical Center

Naval Hospital Camp Pendleton

Investigators

Study Chair:	C. Craig Formby, PhD	The University of Alabama, Tuscaloosa
Study Director:	Roberta W Scherer, PhD	Johns Hopkins School of Public Health

More Information

No publications provided

Responsible Party:	Roberta Scherer, Director, Data Coordinating Center, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:	NCT01177137 History of Changes
Other Study ID Numbers:	U01DC007422, U01DC007422
Study First Received:	August 5, 2010
Last Updated:	February 7, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:

tinnitus
tinnitus retraining therapy
standard of care
directive counseling

sound therapy
tinnitus questionnaire
tinnitus handicap inventory

Additional relevant MeSH terms:

Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases

Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2012