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| ID | Type | Description | Link |
|---|---|---|---|
| U01DC007422 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
| University of Alabama, Tuscaloosa | OTHER |
| David Grant U.S. Air Force Medical Center | FED |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRT | Experimental | TRT includes treatment with a conventional sound generator (SG) and directive counseling (DC) |
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| Partial TRT | Other | Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). |
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| Standard of Care (SC) | Other | The standard of care arm includes care as typically delivered in US military medical centers |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| C. Craig Formby, PhD | The University of Alabama, Tuscaloosa | Study Chair |
| Roberta W Scherer, PhD | Johns Hopkins Bloomberg School of Public Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Hospital Camp Pendleton | Camp Pendleton | California | 92055-5191 | United States | ||
| Naval Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25319676 | Background | 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. | |
| 23571304 | Background |
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Requests for limited datasets may be made to the TRTT Data Coordinating Center
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| ID | Title | Description |
|---|---|---|
| FG000 | Tinnitus Retraining Therapy (TRT) | TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant 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, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 14, 2013 |
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| 59th Medical Wing |
| FED |
| United States Naval Medical Center, San Diego | FED |
| United States Naval Medical Center, Portsmouth | FED |
| Naval Hospital Camp Pendleton | FED |
| Walter Reed National Military Medical Center | FED |
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| 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) | 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. |
|
| 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. |
|
| 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. |
|
| 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. | 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" | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline to 3, 6, 12, and 18 months follow-up |
| San Diego |
| California |
| 92134 |
| United States |
| David Grant Medical Center | Travis Air Force Base | California | 94535 | United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
| Wilford Hall Medical Center | Lackland Air Force Base | Texas | 78236-5300 | United States |
| Portsmouth Naval Medical Center | Portsmouth | Virginia | 23705-2103 | United States |
| 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. |
| 35073492 | Derived | 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. |
| 32703244 | 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. |
| 31120533 | 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. |
| 29792074 | 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. |
| FG001 | Partial Tinnitus Retraining Therapy (Partial TRT) | Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant 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, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process. |
| FG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tinnitus Retraining Therapy (TRT) | TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant 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, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process. |
| BG001 | Partial Tinnitus Retraining Therapy (Partial TRT) | Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant 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, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process. |
| BG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Marital status | Count of Participants | Participants |
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| Smoking status | Count of Participants | Participants |
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| Duration of tinnitus as a problem | Count of Participants | Participants |
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| Tinnitus type of sound | Count of Participants | Participants |
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| Tinnitus location | Count of Participants | Participants |
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| Baseline scores on the Tinnitus Questionnaire and sub-scales | The Tinnitus Questionnaire has 52 questions, scored as 0, 1, or 2. The total score is the sum of the scores of all questions and ranges from 0 to 102, with higher scores indicating more tinnitus distress. Sub-scales (range of scores) include auditory perceptual difficulties (0 to 14), emotional distress (0 to 38), intrusiveness (0 to 14), sleep disturbance (0 to 8), and somatic complaint (0 to 8). | Mean | Standard Deviation | units on a scale |
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| Baseline scores on Tinnitus Functional Index and sub-scales | The Tinnitus Functional Index (TFI) has 25 questions, scored from 0 to 10. The total score ranges from 0 to 100, with higher scores indicating more tinnitus distress. All sub-scales are normalized to range from 0 to 100 scores. Sub-scales include auditory difficulties, cognitive interference, emotional distress, intrusiveness, reduced sense of control, reduced quality of life, relaxation interference, and sleep disturbance. | Mean | Standard Deviation | units on a scale |
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| Baseline scores on the Tinnitus Handicap Inventory and sub-scales | The Tinnitus Handicap Inventory has 25 questions scored as 0, 2, or 4 for "no", "sometimes", and "yes" respectively for a total score ranging from 0 to 100, with higher scores indicated more tinnitus distress. Subscales (ranges for scores) are functional (0 to 44), emotional (0 to 36) and catastrophic (0 to 20). | Mean | Standard Deviation | units on a scale |
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| Rank of tinnitus as problem | The question "How much of a problem is tinnitus?" was scored on a visual analogue scale from 0 ("no problem at all") to 10 "as much as you can imagine". | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Intention to treat, including data from all participants with at least one follow-up visit | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3, 6, 12, and 18 months follow-up |
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| Secondary | 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. | Intention to treat, including data from all participants with at least one follow-up visit | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3, 6, 12, and 18 months |
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| Secondary | 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. | Intention to treat, including data from all participants with at least one follow-up visit | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3. 6. 12. and 18 months |
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| Secondary | 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" | Intention to treat, including data from all participants with at least one follow-up visit | Posted | Mean | Standard Deviation | units on a scale | Baseline to 6, 12, and 18 months follow-up |
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| Secondary | 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. | Intention to treat, including data from all participants with at least one follow-up visit | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3, 6, 12, and 18 months follow-up |
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| Secondary | 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. | Intention to treat, including data from all participants with at least one follow-up visit | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3, 6, 12, and 18 months follow-up |
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| Secondary | 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. | Intention to treat, including all data from participants with at least one follow-up visit | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3, 6, 12, and 18 months follow-up |
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| Secondary | 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. | Intention to treat, including data from all participants with at least one follow-up visit | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3, 6, 12, and 18 months follow-up |
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| Secondary | 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. | Intention to treat, including data from all participants with at least one follow-up visit | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3, 6, 12, and 18 months follow-up |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intention to treat, including data from all participants with at least one follow-up visit | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3, 6, 12, and 18 months follow-up |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intention to treat, including data from all participants with at least one follow-up visit | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3, 6, 12, and 18 months follow-up |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intention to treat, including data from all participants with at least one follow-up visit | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3, 6, 12, and 18 months follow-up |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intention to treat, including data from all participants with at least one follow-up visit | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3, 6, 12, and 18 months follow-up |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intention to treat, including data from all participants with at least one follow-up visit | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3, 6, 12, and 18 months follow-up |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intention to treat, including data from all participants with at least one follow-up visit | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3, 6, 12, and 18 months follow-up |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intention to treat, including data from all participants with at least one follow-up visit | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3, 6, 12, and 18 months follow-up |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intention to treat, including data from all participants with at least one follow-up visit | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3, 6, 12, and 18 months follow-up |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intention to treat, including data from all participants with at least one follow-up visit | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3, 6, 12, and 18 months follow-up |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intention to treat, including data from all participants with at least one follow-up visit | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3, 6, 12, and 18 months follow-up |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intention to treat, including data from all participants with at least one follow-up visit | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3, 6, 12, and 18 months follow-up |
|
Adverse events were collected from baseline to the end of the 18 month follow-up period.
The only adverse event systematically collected was depression, assessed as a score of 4 or more or endorsement of suicidal ideation on the Beck Depression Inventory Short Form. This instrument was administered at each study visit (baseline, 3, 6, 12, and 18 months follow-up).
Other adverse events were not systematically collected, but reported at the time of incidence.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tinnitus Retraining Therapy (TRT) | TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant 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, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process. | 0 | 51 | 0 | 51 | 10 | 51 |
| EG001 | Partial Tinnitus Retraining Therapy (Partial TRT) | Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant 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, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process. | 0 | 51 | 3 | 51 | 12 | 51 |
| EG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. | 0 | 49 | 0 | 49 | 9 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Unspecified cancer |
| |
| Surgery | Nervous system disorders | Non-systematic Assessment | Surgery due to blood clot compressing cerebellum |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | Systematic Assessment | Score of 4 of more on Beck Depression Inventory at any visit |
| |
| Sudden hearing loss | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Pain and swollen ear canal | Ear and labyrinth disorders | Non-systematic Assessment | No redness or oozing |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberta W. Scherer, Director Data Coordinating Center | Center for Clinical Trials and Evidence Synthesis, Johns Hopkins Bloomberg School of Public Health | 410 502 4636 | rschere1@jhu.edu |
| Oct 24, 2018 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D037001 | Directive Counseling |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or not reported |
|
| Single/never married |
|
| Divorced/separated |
|
| Widowed |
|
| Other/unknown |
|
| Previous smoker |
|
| Never smoked |
|
| More than 2 years but less than 5 years |
|
| More than 5 years |
|
| Unknown/missing |
|
| Low frequency (buzzing, puldating, ocean, etc. |
|
| High frequency (hissing, sizzling, ectc.) |
|
| Other (clicking, crickets, etc.) |
|
| Missing |
|
| Both ears |
|
| In the head |
|
| In the head and one or both ears |
|
| Auditory perceptual |
|
| Emotional distress |
|
| Intrusiveness |
|
| Sleep disturbance |
|
| Somatic complaint |
|
| Auditory difficulties |
|
| Cognitive interference |
|
| Emotional distress |
|
| Intrusiveness |
|
| Reduced sense of control |
|
| Reduced quality of life |
|
| Relaxation difficulties |
|
| Sleep disturbance |
|
| Functional subscale |
|
| Emotional subscale |
|
| Catastrophic subscale |
|
| Change from baseline to 6 months |
|
|
| Change from baseline to 12 months |
|
|
| Change from baseline to 18 months |
|
|
| repeated measures GEE model | 0.31 | The a priori threshold for statistical significance was <0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care. | Slope | -2.80 | Standard Error of the Mean | 2.78 | 2-Sided | 95 | -8.27 | 2.65 | Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation | Superiority |
| OG001 | Partial Tinnitus Retraining Therapy (Partial TRT) | Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant 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, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process. |
| OG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. |
|
|
|
| OG001 |
| Partial Tinnitus Retraining Therapy (Partial TRT) |
Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant 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, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process. |
| OG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. |
|
|
|
Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC).
The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices.
Directive Counseling (DC) involves a one to two-hour educational session during which the participant 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, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.
| OG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. |
|
|
Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). 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. 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. |
| OG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. |
|
|
|
Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC).
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.
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.
| OG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. |
|
|
|
Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC).
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.
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.
| OG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. |
|
|
|
Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC).
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.
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.
| OG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. |
|
|
|
Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC).
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.
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.
| OG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. |
|
|
|
Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC).
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.
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.
| OG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. |
|
|
|
Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). 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. 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. |
| OG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. |
|
|
|
Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC).
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.
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.
| OG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. |
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Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC).
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.
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.
| OG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. |
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Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC).
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.
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.
| OG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. |
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Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). 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. 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. |
| OG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. |
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Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC).
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.
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.
| OG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. |
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Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). 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. 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. |
| OG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. |
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Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC).
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.
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.
| OG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. |
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Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC).
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.
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.
| OG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. |
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Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC).
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.
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.
| OG002 | Standard of Care (SC) | The standard of care arm includes care as typically delivered in US military medical centers 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. |
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