Subjective TinnitusPhase 3TRTTNCT01177137

Tinnitus Retraining Therapy Trial

A Phase 3 study testing Conventional sound generator (SG) and Directive Counseling (DC) in people with Subjective Tinnitus, run by Johns Hopkins Bloomberg School of Public Health at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Subjective Tinnitus
What is being tested?: Conventional sound generator (SG) and Directive Counseling (DC)
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 151 participants
Where: 6 sitesUnited States
Study dates: Jul 2011to Feb 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 25Show fewer

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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Naval Hospital Camp Pendleton
Camp Pendleton, California, 92055-5191
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236-5300
Portsmouth Naval Medical Center
Portsmouth, Virginia, 23705-2103
Naval Medical Center
San Diego, California, 92134
David Grant Medical Center
Travis Air Force Base, California, 94535

Other trials in United States

About this study

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.

Read the 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.

Conditions: Subjective Tinnitus
Being tested: Conventional sound generator (SG), Placebo sound generator (placebo SG), Standard of Care (SC), Directive Counseling (DC)
Keywords: tinnitus, tinnitus retraining therapy, standard of care, directive counseling, sound therapy, tinnitus questionnaire, tinnitus handicap inventory
Medical subject headings: Tinnitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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)
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.
Standard of Care (SC)Behavioural
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.
Directive Counseling (DC)Behavioural
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.
Directive Counseling (DC)Behavioural
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.

Study groups in NCT01177137
Study group	Role	What they receive
TRT	Experimental	TRT includes treatment with a conventional sound generator (SG) and directive counseling (DC) Receives: 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). Receives: 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 Receives: Behavioral: Standard of Care (SC)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
The TFI is a tinnitus-specific health -related quality of life instrument. Subscales include intrusiveness, reduced sense of control, cognitive interference, sleep disturbance, auditory difficulties (related to tinnitus), relaxation interference, reduced quality of life, and emotional distress. The total and each subscale score ranges from 0 to 100 with higher scores indicated a greater impact of tinnitus on quality of life.
Measured: 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
Change in THI score from baseline to 3 months follow-up. The THI is a tinnitus-specific health-related quality of life instrument. Subscales include the functional (scored 0 to 44), emotional (scored 0 to 36) and catastrophic (scored 0 to 20). The total score ranges from 0 to 100 with higher scores indicating a greater impact of tinnitus on quality of life.
Measured: 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
10 point visual analog scale asking "How much of a problem is tinnitus?" on a scale from 0 "no problem at all" to 10 "as much as you can imagine"
Measured: 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.
Change in Tinnitus Questionnaire emotional distress sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 38 with higher scores representing greater emotional distress.
Measured: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores.
Change in Tinnitus Questionnaire intrusiveness sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 14 with higher scores representing greater intrusiveness of the tinnitus.
Measured: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Questionnaire Auditory Perceptual Difficulties Sub-scale Scores.
Change in Tinnitus Questionnaire auditory perceptual sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 14 with higher scores representing greater auditory difficulties.
Measured: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Questionnaire Sleep Disturbance Sub-scale Scores.
Change in Tinnitus Questionnaire sleep disturbance sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 8 with higher scores representing greater sleep disturbance.
Measured: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Questionnaire Somatic Complaint Sub-scale Scores.
Change in Tinnitus Questionnaire somatic complaint sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 8 with higher scores representing greater somatic complaints.
Measured: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Functional Index Intrusiveness Sub-scale Scores.
Change in Tinnitus Functional Index intrusiveness sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater intrusiveness of the tinnitus.
Measured: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Functional Index Reduced Sense of Control Sub-scale Scores.
Change in Tinnitus Functional Index reduced sense of control sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater reduction of control.
Measured: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Functional Index Cognitive Interference Sub-scale Scores.
Change in Tinnitus Functional Index cognitive interference sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater cognitive interference.
Measured: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Functional Index Sleep Disturbance Sub-scale Scores.
Change in Tinnitus Functional Index sleep disturbance sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater sleep disturbance.
Measured: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Functional Index Auditory Difficulties Sub-scale Scores.
Change in Tinnitus Functional Index auditory difficulties sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater auditory difficulties.
Measured: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Functional Index Relaxation Interference Sub-scale Scores.
Change in Tinnitus Functional Index relaxation interference sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater relaxation interference.
Measured: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Functional Index Emotional Distress Sub-scale Scores.
Change in Tinnitus Functional Index emotional distress sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater emotional distress.
Measured: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Functional Index Reduced Quality of Life Sub-scale Scores.
Change in Tinnitus Functional Index reduced quality of life sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater reduction in quality of life.
Measured: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Handicap Inventory Functional Sub-scale Scores.
Change in Tinnitus Handicap Inventory functional sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 44 with higher scores representing greater functional difficulties.
Measured: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Handicap Inventory Emotional Sub-scale Scores.
Change in Tinnitus Handicap Inventory emotional sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 36 with higher scores representing greater emotional distress.
Measured: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Handicap Inventory Catastrophic Sub-scale Scores.
Change in Tinnitus Handicap Inventory catastrophic sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 20 with higher scores representing greater catastrophic effect of the tinnitus.
Measured: Baseline to 3, 6, 12, and 18 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Feb 2017

First posted6 Aug 2010 (estimated)
Study startJul 2011
Primary completionFeb 2017
Study completionFeb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Subjective TinnitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 151 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01177137
Sponsor's protocol ID: U01DC007422
Other IDs: U01DC007422
Acronym: TRTT
Status last verified: Oct 2018
First submitted: 5 Aug 2010
Last updated: 21 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Requests for limited datasets may be made to the TRTT Data Coordinating Center

Publications

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.
PubMed 25319676
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.
PubMed 23571304
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.
PubMed 35073492
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.
PubMed 32703244
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.
PubMed 31120533
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.
PubMed 29792074

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Non-Invasive Neurofeedback Training to Alleviate Tinnitus Distress
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COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY
Somatosensory Tinnitus, Subjektif tınnitus

All Subjective Tinnitus trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tinnitus Retraining Therapy Trial
ClinicalTrials.gov ID: NCT01177137
Acronym / sponsor ID: TRTT / U01DC007422
Conditions: Subjective Tinnitus
Keywords: tinnitus, tinnitus retraining therapy, standard of care, directive counseling, sound therapy, tinnitus questionnaire, tinnitus handicap inventory
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 151 participants (actual)
Lead sponsor: Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD), University of Alabama, Tuscaloosa, David Grant U.S. Air Force Medical Center, 59th Medical Wing, United States Naval Medical Center, San Diego, United States Naval Medical Center, Portsmouth, Naval Hospital Camp Pendleton, Walter Reed National Military Medical Center
Study start: Jul 2011 (actual)
Primary completion: Feb 2017 (actual)
Study completion: Feb 2017 (actual)
First posted: 6 Aug 2010 (estimated)
Results: Posted 21 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
TRT	Experimental	Device: Conventional sound generator (SG), Behavioral: Directive Counseling (DC)TRT includes treatment with a conventional sound generator (SG) and directive counseling (DC)
Partial TRT	Other	Device: Placebo sound generator (placebo SG), Behavioral: Directive Counseling (DC)Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC).
Standard of Care (SC)	Other	Behavioral: Standard of Care (SC)The standard of care arm includes care as typically delivered in US military medical centers

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (25 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Conventional sound generator (SG)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)	Device	TRT
Placebo sound generator (placebo SG)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.	Device	Partial TRT
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.	Behavioural	Standard of Care (SC)
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.	Behavioural	TRT
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.	Behavioural	Partial TRT

Primary outcome

Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
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.

19 secondary outcomes

Change in Tinnitus Functional Index (TFI) From Baseline to 3, 6, 12, and 18 Months
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Questionnaire Auditory Perceptual Difficulties Sub-scale Scores.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Questionnaire Sleep Disturbance Sub-scale Scores.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Questionnaire Somatic Complaint Sub-scale Scores.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Functional Index Intrusiveness Sub-scale Scores.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Functional Index Reduced Sense of Control Sub-scale Scores.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Functional Index Cognitive Interference Sub-scale Scores.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Functional Index Sleep Disturbance Sub-scale Scores.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Functional Index Auditory Difficulties Sub-scale Scores.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Functional Index Relaxation Interference Sub-scale Scores.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Functional Index Emotional Distress Sub-scale Scores.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Functional Index Reduced Quality of Life Sub-scale Scores.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Handicap Inventory Functional Sub-scale Scores.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Handicap Inventory Emotional Sub-scale Scores.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Change in Tinnitus Handicap Inventory Catastrophic Sub-scale Scores.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up

Results and safety

Results posted to the registry on 21 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tinnitus Retraining Therapy (TRT)	51	41
Partial Tinnitus Retraining Therapy (Partial TRT)	51	41
Standard of Care (SC)	49	47

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

Time frame: Baseline to 3, 6, 12, and 18 months follow-up. Mean (Standard Deviation). Unit: units on a scale

Measure	Tinnitus Retraining Therapy (TRT) n = 44	Partial Tinnitus Retraining Therapy (Partial TRT) n = 46	Standard of Care (SC) n = 46
Change from baseline to 3 months	-17.8 (13.6)	-15.4 (15.9)	-11.5 (13.4)
Change from baseline to 6 months	-22.0 (15.6)	-18.3 (15.4)	-14.5 (14.8)
Change from baseline to 12 months	-21.1 (15.1)	-21.8 (15.9)	-17.6 (14.0)
Change from baseline to 18 months	-18.2 (15.2)	-19.0 (15.9)	-16.5 (16.3)

Tinnitus Retraining Therapy (TRT) vs Standard of Care (SC): Slope: -2.35 (95% CI -8.77 to 4.07), p = 0.47, repeated measures GEE model
Partial Tinnitus Retraining Therapy (Partial TRT) vs Standard of Care (SC): Slope: -2.80 (95% CI -8.27 to 2.65), p = 0.31, repeated measures GEE model

Population analysed: Intention to treat, including data from all participants with at least one follow-up visit

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from baseline to the end of the 18 month follow-up period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tinnitus Retraining Therapy (TRT)	0 of 51 (0%)	10 of 51 (19.6%)	0 of 51
Partial Tinnitus Retraining Therapy (Partial TRT)	3 of 51 (5.9%)	12 of 51 (23.5%)	0 of 51
Standard of Care (SC)	0 of 49 (0%)	9 of 49 (18.4%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25319676Scherer 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.
Background: PubMed 23571304Formby 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.
Derived from this study: PubMed 35073492Formby 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.
Derived from this study: PubMed 32703244Scherer 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.
Derived from this study: PubMed 31120533Tinnitus 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.
Derived from this study: PubMed 29792074Scherer 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.
Individual participant dataSharing planned: Yes. Requests for limited datasets may be made to the TRTT Data Coordinating Center

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

C. Craig Formby, PhD study chair

The University of Alabama, Tuscaloosa

Roberta W Scherer, PhD study director

Johns Hopkins Bloomberg School of Public Health

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months (time frame: Baseline to 3, 6, 12, and 18 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01177137, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.