Tinnitus Retraining Therapy Trial

NCT01177137 | Completed Phase 3 Results DMC

• 1 other identifier: U01DC007422
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Subjective Tinnitus

Keywords

tinnitus; tinnitus retraining therapy; standard of care; directive counseling; sound therapy; tinnitus questionnaire; tinnitus handicap inventory

Outcome Measures

Primary Outcomes (1)

• Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months

  The TQ is a tinnitus-specific health-related quality of life instrument with 52 statements that the respondent marks as true, partly true, or not true. The TQ is scored from 0 to 102, with higher scores indicating more of an impact of the tinnitus on quality of life. Subscales include emotional distress, intrusiveness, auditory perceptual difficulties, sleep disturbance,and somatic complaints.

  Baseline to 3, 6, 12, and 18 months follow-up

Secondary Outcomes (19)

• Change in Tinnitus Functional Index (TFI) From Baseline to 3, 6, 12, and 18 Months

  Baseline and 3, 6, 12, and 18 months

• Change in Tinnitus Handicap Inventory (THI) Score From Baseline to 3, 6, 12, and 18 Months Follow-up

  Baseline and 3. 6. 12. and 18 months

• Change in Tinnitus Retraining Therapy Interview Visual Analogue Scales at 3, 6, 12, and 18 Months Follow-up

  Baseline to 6, 12, and 18 months follow-up

• Change in Tinnitus Questionnaire Emotional Distress Sub-scale Scores From Baseline to 3, 6, 12, and 18 Months.

  Baseline to 3, 6, 12, and 18 months follow-up

• Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores.

  Baseline to 3, 6, 12, and 18 months follow-up

Study Arms (3)

TRT

EXPERIMENTAL

TRT includes treatment with a conventional sound generator (SG) and directive counseling (DC)

Device: Conventional sound generator (SG); Behavioral: Directive Counseling (DC)

Partial TRT

OTHER

Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC).

Device: Placebo sound generator (placebo SG); Behavioral: Directive Counseling (DC)

Standard of Care (SC)

OTHER

The standard of care arm includes care as typically delivered in US military medical centers

Behavioral: Standard of Care (SC)

Interventions

Conventional sound generator (SG) DEVICE

Conventional SGs: Tranquil model sound generators (General Hearing Instruments, Inc.) are either inside or 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)

TRT

Placebo sound generator (placebo SG) DEVICE

Tranquil model placebo sound generators (General Hearing Instruments, Inc.) are either inside or outside-the-ear devices that generate a sound different from the active devices.

Partial TRT

Standard of Care (SC) BEHAVIORAL

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.

Standard of Care (SC)

Directive Counseling (DC) BEHAVIORAL

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.

TRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• University of Alabama, Tuscaloosa: collaborator
• David Grant U.S. Air Force Medical Center: collaborator
• 59th Medical Wing: collaborator
• United States Naval Medical Center, San Diego: collaborator
• United States Naval Medical Center, Portsmouth: collaborator
• Naval Hospital Camp Pendleton: collaborator
• Walter Reed National Military Medical Center: collaborator

Study Sites (6)

Naval Hospital Camp Pendleton

Camp Pendleton, California, 92055-5191, United States

Location

Naval Medical Center

San Diego, California, 92134, United States

Location

David Grant Medical Center

Travis Air Force Base, California, 94535, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236-5300, United States

Location

Portsmouth Naval Medical Center

Portsmouth, Virginia, 23705-2103, United States

Location

Related Publications (6)

• Scherer RW, Formby C, Gold S, Erdman S, Rodhe C, Carlson M, Shade D, Tucker M, Sensinger LM, Hughes G, Conley GS, Downey N, Eades C, Jylkka M, Haber-Perez A, Harper C, Russell SK, Sierra-Irizarry B, Sullivan M; Tinnitus Retraining Therapy Trial Research Group. The Tinnitus Retraining Therapy Trial (TRTT): study protocol for a randomized controlled trial. Trials. 2014 Oct 15;15:396. doi: 10.1186/1745-6215-15-396.

  PMID: 25319676 BACKGROUND

• Formby C, Scherer R; TRTT Study Group. Rationale for the tinnitus retraining therapy trial. Noise Health. 2013 Mar-Apr;15(63):134-42. doi: 10.4103/1463-1741.110299.

  PMID: 23571304 BACKGROUND

• Formby C, Yang X, Scherer RW. Contributions of Counseling and Sound Generator Use in Tinnitus Retraining Therapy: Treatment Response Dynamics Assessed in a Secondary Analysis of a Randomized Trial. J Speech Lang Hear Res. 2022 Feb 9;65(2):816-828. doi: 10.1044/2021_JSLHR-21-00210. Epub 2022 Jan 24.

  PMID: 35073492 DERIVED

• Scherer RW, Erdman SA, Gold S, Formby C; TRTT Research Group. Treatment fidelity in the Tinnitus Retraining Therapy Trial. Trials. 2020 Jul 23;21(1):670. doi: 10.1186/s13063-020-04530-9.

  PMID: 32703244 DERIVED

• Tinnitus Retraining Therapy Trial Research Group; Scherer RW, Formby C. Effect of Tinnitus Retraining Therapy vs Standard of Care on Tinnitus-Related Quality of Life: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2019 Jul 1;145(7):597-608. doi: 10.1001/jamaoto.2019.0821.

  PMID: 31120533 DERIVED

• Scherer RW, Sensinger LD, Sierra-Irizarry B, Formby C; TRTT Research Group. Lessons learned conducting a multi-center trial with a military population: The Tinnitus Retraining Therapy Trial. Clin Trials. 2018 Oct;15(5):429-435. doi: 10.1177/1740774518777709. Epub 2018 May 23.

  PMID: 29792074 DERIVED

MeSH Terms

Conditions

Tinnitus

Interventions

Standard of Care; Directive Counseling

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Roberta W. Scherer, Director Data Coordinating Center
• Organization: Center for Clinical Trials and Evidence Synthesis, Johns Hopkins Bloomberg School of Public Health

rschere1@jhu.edu

410 502 4636

Study Officials

• C. Craig Formby, PhD

  The University of Alabama, Tuscaloosa

  STUDY CHAIR

• Roberta W Scherer, PhD

  Johns Hopkins Bloomberg School of Public Health

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 6, 2010
• Study Start: July 1, 2011
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: November 21, 2018
• Results First Posted: November 21, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share

Locations

US (6)