Subjective Tinnitus
Conditions
Keywords
tinnitus, tinnitus retraining therapy, standard of care, directive counseling, sound therapy, tinnitus questionnaire, tinnitus handicap inventory
Brief summary
The primary purpose of the Tinnitus Retraining Therapy Trial (TRTT) is to assess the efficacy of tinnitus retraining therapy (TRT) as a treatment for severe debilitating tinnitus. TRT is a non-medical intervention that uses directive counseling (DC) and sound therapy (ST)to habituate the patient's associated negative emotional reactions to tinnitus, its perception, and ultimately, its impact on the patient's life.
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.
Interventions
DEVICEConventional 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)
DEVICEPlacebo 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.
BEHAVIORALStandard 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.
BEHAVIORALDirective 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.
Sponsors
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
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or above * Subjective severe tinnitus, defined as a score on the Tinnitus Questionnaire (TQ) greater than or equal to 40 * Eligible for care at a Department of Defense Clinical Center * Speaks English well enough to complete a series of questionnaires and benefit from counseling
Exclusion criteria
* Involvement in pending tinnitus-related financial claims or litigation except that associated with usual Veterans' Administration retirement claims * Tinnitus of less than 12 months duration * Treatment for tinnitus within previous 12 months * Routine unavoidable exposure to hazardous noise * Use of a cancer chemotherapeutic drug within previous 12 months * Treatment for head or neck injury within previous 24 months * Treatment for an emotional, psychological, or psychiatric condition within previous 12 months resulting in inability to participate in the trial or complete all followup visits, as assessed by best clinical judgment * Requirement for use of an ototoxic drug * Hearing impairment, defined by audiometric thresholds \> 30 dB HL at and below 2,000 Hz and \> 40 dB HL at 4,000 and 8,000 Hz * Required use of hearing aids * Fluctuating hearing loss at a level that would interfere with the reliability of study results * One or more prominent spontaneous otoacoustic emissions, defined as the presence of a spontaneous otoacoustic emission spike that is 3 or more times larger than the measured variation in amplitude across the remaining frequency range and/or if the emission corresponds in pitch to the tinnitus pitch * Pulsatile somatosounds suggesting presence of abnormal vasculature or high blood pressure contributing to the tinnitus * Feigning tinnitus or hearing loss * Evidence by audiological testing of a treatable etiology of the tinnitus, such as conductive hearing impairment as shown by pure-tone thresholds, abnormal acoustic immittance, abnormal stapedial reflex test, or abnormal auditory brainstem response * Predisposing disease with tinnitus symptoms amenable to medical or surgical intervention, including but not limited to; chronic otitis media, otosclerosis, vestibular disorder or dizziness, Eustachian tube, middle ear, or inner ear disease, Lyme disease or ear autoimmune disease, malocclusion or temporomandibular joint disease, uncontrolled allergies, aberrant ear, head, or neck blood vasculature or glomus tumor, neurological condition such as multiple sclerosis or ear-related demyelinating disease, perilymphatic fistula, or facial weakness or paralysis * Meniere's disease * Uncontrolled diabetes, defined as blood glucose consistently ≥ 200 mg/dl or an HBA1c above 8% * Evidence from any laboratory study that suggests an etiology for the tinnitus that is treatable, including, but not limited to, abnormal thyroid stimulating hormone (TSH) or thyroid hormone (T3 or T4) levels, positive fluorescent treponemal antibody (FTA) test, or positive Lyme titer * Evidence of a tumor contributing to the tinnitus, including an acoustic neuroma (or vestibular schwannoma), cerebellopontine angle tumor, skull base tumor, or any other type of tumor that the examining physician believes is responsible for the tinnitus * Diagnosis of traumatic head or brain injury requiring treatment * Diagnosis of an emotional, psychological, or psychiatric condition requiring treatment and resulting in inability to participate in the trial or complete all followup visits, as assessed by best clinical judgment * Inability or unwillingness of patient to comply with study requirements * Unwillingness of Clinical Center Director to randomize the patient to treatment due to the presence of any condition, physical, mental or social, which is likely to affect the patient returning for follow-up visits on schedule or which is likely to impair his or her performance on the functional tests * Inability or unwillingness of patient to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tinnitus Handicap Inventory (THI) Score From Baseline to 3, 6, 12, and 18 Months Follow-up | Baseline and 3. 6. 12. and 18 months | Change in 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. |
| Change in Tinnitus Retraining Therapy Interview Visual Analogue Scales at 3, 6, 12, and 18 Months Follow-up | Baseline to 6, 12, and 18 months follow-up | 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 |
| Change in Tinnitus Questionnaire Emotional Distress Sub-scale Scores From Baseline to 3, 6, 12, and 18 Months. | Baseline to 3, 6, 12, and 18 months follow-up | Change in Tinnitus Questionnaire emotional distress sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 38 with higher scores representing greater emotional distress. |
| Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores. | Baseline to 3, 6, 12, and 18 months follow-up | 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. |
| Change in Tinnitus Questionnaire Auditory Perceptual Difficulties Sub-scale Scores. | Baseline to 3, 6, 12, and 18 months follow-up | 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. |
| Change in Tinnitus Questionnaire Sleep Disturbance Sub-scale Scores. | Baseline to 3, 6, 12, and 18 months follow-up | 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. |
| Change in Tinnitus Questionnaire Somatic Complaint Sub-scale Scores. | Baseline to 3, 6, 12, and 18 months follow-up | 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. |
| Change in Tinnitus Functional Index Intrusiveness Sub-scale Scores. | Baseline to 3, 6, 12, and 18 months follow-up | 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. |
| Change in Tinnitus Functional Index Reduced Sense of Control Sub-scale Scores. | Baseline to 3, 6, 12, and 18 months follow-up | 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. |
| Change in Tinnitus Functional Index (TFI) From Baseline to 3, 6, 12, and 18 Months | Baseline and 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. |
| Change in Tinnitus Functional Index Sleep Disturbance Sub-scale Scores. | Baseline to 3, 6, 12, and 18 months follow-up | 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. |
| Change in Tinnitus Functional Index Auditory Difficulties Sub-scale Scores. | Baseline to 3, 6, 12, and 18 months follow-up | 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. |
| Change in Tinnitus Functional Index Relaxation Interference Sub-scale Scores. | Baseline to 3, 6, 12, and 18 months follow-up | 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. |
| Change in Tinnitus Functional Index Emotional Distress Sub-scale Scores. | Baseline to 3, 6, 12, and 18 months follow-up | 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. |
| Change in Tinnitus Functional Index Reduced Quality of Life Sub-scale Scores. | Baseline to 3, 6, 12, and 18 months follow-up | 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. |
| Change in Tinnitus Handicap Inventory Functional Sub-scale Scores. | Baseline to 3, 6, 12, and 18 months follow-up | 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. |
| Change in Tinnitus Handicap Inventory Emotional Sub-scale Scores. | Baseline to 3, 6, 12, and 18 months follow-up | 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. |
| Change in Tinnitus Handicap Inventory Catastrophic Sub-scale Scores. | Baseline to 3, 6, 12, and 18 months follow-up | 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. |
| Change in Tinnitus Functional Index Cognitive Interference Sub-scale Scores. | Baseline to 3, 6, 12, and 18 months follow-up | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 51 |
| 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. | 51 |
| 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. | 49 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 10 | 10 | 2 |
Baseline characteristics
| Characteristic | Partial Tinnitus Retraining Therapy (Partial TRT) | Tinnitus Retraining Therapy (TRT) | Standard of Care (SC) | Total |
|---|---|---|---|---|
| Age, Continuous | 50.9 years STANDARD_DEVIATION 11.2 | 51.1 years STANDARD_DEVIATION 12.6 | 49.9 years STANDARD_DEVIATION 10.6 | 50.6 years STANDARD_DEVIATION 11.3 |
| Baseline scores on the Tinnitus Handicap Inventory and sub-scales Catastrophic subscale | 8.7 units on a scale STANDARD_DEVIATION 4.2 | 8.2 units on a scale STANDARD_DEVIATION 3.4 | 8.0 units on a scale STANDARD_DEVIATION 3.5 | 8.3 units on a scale STANDARD_DEVIATION 3.7 |
| Baseline scores on the Tinnitus Handicap Inventory and sub-scales Emotional subscale | 12.7 units on a scale STANDARD_DEVIATION 9 | 11.3 units on a scale STANDARD_DEVIATION 6.2 | 11.4 units on a scale STANDARD_DEVIATION 7.1 | 11.8 units on a scale STANDARD_DEVIATION 7.5 |
| Baseline scores on the Tinnitus Handicap Inventory and sub-scales Functional subscale | 20.9 units on a scale STANDARD_DEVIATION 9.5 | 18.4 units on a scale STANDARD_DEVIATION 6.2 | 19.3 units on a scale STANDARD_DEVIATION 8.4 | 19.5 units on a scale STANDARD_DEVIATION 8.2 |
| Baseline scores on the Tinnitus Handicap Inventory and sub-scales Total | 42.3 units on a scale STANDARD_DEVIATION 20.7 | 37.8 units on a scale STANDARD_DEVIATION 13 | 38.6 units on a scale STANDARD_DEVIATION 16.7 | 39.6 units on a scale STANDARD_DEVIATION 17.1 |
| Baseline scores on the Tinnitus Questionnaire and sub-scales Auditory perceptual | 7.1 units on a scale STANDARD_DEVIATION 3 | 7.2 units on a scale STANDARD_DEVIATION 2.8 | 7.7 units on a scale STANDARD_DEVIATION 3.7 | 7.3 units on a scale STANDARD_DEVIATION 3.1 |
| Baseline scores on the Tinnitus Questionnaire and sub-scales Emotional distress | 17.0 units on a scale STANDARD_DEVIATION 6.6 | 17.2 units on a scale STANDARD_DEVIATION 6.2 | 15.8 units on a scale STANDARD_DEVIATION 5.5 | 16.7 units on a scale STANDARD_DEVIATION 6.1 |
| Baseline scores on the Tinnitus Questionnaire and sub-scales Intrusiveness | 9.9 units on a scale STANDARD_DEVIATION 2.1 | 9.9 units on a scale STANDARD_DEVIATION 2 | 9.8 units on a scale STANDARD_DEVIATION 1.8 | 9.9 units on a scale STANDARD_DEVIATION 2 |
| Baseline scores on the Tinnitus Questionnaire and sub-scales Sleep disturbance | 4.3 units on a scale STANDARD_DEVIATION 2.2 | 4.9 units on a scale STANDARD_DEVIATION 2.3 | 4.8 units on a scale STANDARD_DEVIATION 2.4 | 4.7 units on a scale STANDARD_DEVIATION 2.3 |
| Baseline scores on the Tinnitus Questionnaire and sub-scales Somatic complaint | 4.5 units on a scale STANDARD_DEVIATION 1.8 | 5.3 units on a scale STANDARD_DEVIATION 1.6 | 4.9 units on a scale STANDARD_DEVIATION 1.7 | 4.9 units on a scale STANDARD_DEVIATION 1.7 |
| Baseline scores on the Tinnitus Questionnaire and sub-scales Total | 54.4 units on a scale STANDARD_DEVIATION 11.5 | 56.4 units on a scale STANDARD_DEVIATION 11.9 | 54.6 units on a scale STANDARD_DEVIATION 11.2 | 55.1 units on a scale STANDARD_DEVIATION 11.5 |
| Baseline scores on Tinnitus Functional Index and sub-scales Auditory difficulties | 45.0 units on a scale STANDARD_DEVIATION 27.2 | 45.1 units on a scale STANDARD_DEVIATION 27.2 | 46.6 units on a scale STANDARD_DEVIATION 25.7 | 45.6 units on a scale STANDARD_DEVIATION 25.9 |
| Baseline scores on Tinnitus Functional Index and sub-scales Cognitive interference | 51.0 units on a scale STANDARD_DEVIATION 22.1 | 42.7 units on a scale STANDARD_DEVIATION 21.2 | 47.8 units on a scale STANDARD_DEVIATION 24.5 | 47.2 units on a scale STANDARD_DEVIATION 22.7 |
| Baseline scores on Tinnitus Functional Index and sub-scales Emotional distress | 31.8 units on a scale STANDARD_DEVIATION 26.1 | 31.6 units on a scale STANDARD_DEVIATION 24.6 | 34.4 units on a scale STANDARD_DEVIATION 23.6 | 32.6 units on a scale STANDARD_DEVIATION 24.7 |
| Baseline scores on Tinnitus Functional Index and sub-scales Intrusiveness | 67.5 units on a scale STANDARD_DEVIATION 18 | 63.3 units on a scale STANDARD_DEVIATION 23.2 | 70.7 units on a scale STANDARD_DEVIATION 17.3 | 67.1 units on a scale STANDARD_DEVIATION 19.8 |
| Baseline scores on Tinnitus Functional Index and sub-scales Reduced quality of life | 35.7 units on a scale STANDARD_DEVIATION 23.1 | 30.1 units on a scale STANDARD_DEVIATION 22.7 | 37.0 units on a scale STANDARD_DEVIATION 25.4 | 34.2 units on a scale STANDARD_DEVIATION 23.8 |
| Baseline scores on Tinnitus Functional Index and sub-scales Reduced sense of control | 63.7 units on a scale STANDARD_DEVIATION 16.7 | 58.6 units on a scale STANDARD_DEVIATION 20.9 | 67.8 units on a scale STANDARD_DEVIATION 19.5 | 63.3 units on a scale STANDARD_DEVIATION 19.3 |
| Baseline scores on Tinnitus Functional Index and sub-scales Relaxation difficulties | 61.9 units on a scale STANDARD_DEVIATION 27.2 | 63.9 units on a scale STANDARD_DEVIATION 23.6 | 68.2 units on a scale STANDARD_DEVIATION 24.4 | 64.6 units on a scale STANDARD_DEVIATION 25.1 |
| Baseline scores on Tinnitus Functional Index and sub-scales Sleep disturbance | 50.3 units on a scale STANDARD_DEVIATION 28.1 | 55.4 units on a scale STANDARD_DEVIATION 30.8 | 61.0 units on a scale STANDARD_DEVIATION 30.2 | 55.5 units on a scale STANDARD_DEVIATION 29.8 |
| Baseline scores on Tinnitus Functional Index and sub-scales Total | 50.3 units on a scale STANDARD_DEVIATION 17.1 | 48.1 units on a scale STANDARD_DEVIATION 17.6 | 53.5 units on a scale STANDARD_DEVIATION 17.3 | 50.6 units on a scale STANDARD_DEVIATION 17.3 |
| Duration of tinnitus as a problem Less than 2 years | 11 Participants | 12 Participants | 6 Participants | 29 Participants |
| Duration of tinnitus as a problem More than 2 years but less than 5 years | 17 Participants | 15 Participants | 20 Participants | 52 Participants |
| Duration of tinnitus as a problem More than 5 years | 22 Participants | 24 Participants | 22 Participants | 68 Participants |
| Duration of tinnitus as a problem Unknown/missing | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Marital status Divorced/separated | 4 Participants | 7 Participants | 4 Participants | 15 Participants |
| Marital status Married/living with partner | 41 Participants | 39 Participants | 41 Participants | 121 Participants |
| Marital status Other/unknown | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Marital status Single/never married | 6 Participants | 4 Participants | 3 Participants | 13 Participants |
| Marital status Widowed | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 5 Participants | 7 Participants | 5 Participants | 17 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 44 Participants | 41 Participants | 41 Participants | 126 Participants |
| Race/Ethnicity, Customized Unknown or not reported | 2 Participants | 3 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 3 Participants | 2 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 5 Participants | 7 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 39 Participants | 36 Participants | 35 Participants | 110 Participants |
| Rank of tinnitus as problem | 6.4 units on a scale STANDARD_DEVIATION 2.2 | 6.2 units on a scale STANDARD_DEVIATION 2.2 | 6.3 units on a scale STANDARD_DEVIATION 2.1 | 6.3 units on a scale STANDARD_DEVIATION 2.2 |
| Sex: Female, Male Female | 14 Participants | 17 Participants | 13 Participants | 44 Participants |
| Sex: Female, Male Male | 37 Participants | 34 Participants | 36 Participants | 107 Participants |
| Smoking status Current smoker | 3 Participants | 0 Participants | 2 Participants | 5 Participants |
| Smoking status Never smoked | 33 Participants | 36 Participants | 36 Participants | 105 Participants |
| Smoking status Previous smoker | 15 Participants | 15 Participants | 11 Participants | 41 Participants |
| Tinnitus location Both ears | 24 Participants | 22 Participants | 20 Participants | 66 Participants |
| Tinnitus location In the head | 11 Participants | 7 Participants | 10 Participants | 28 Participants |
| Tinnitus location In the head and one or both ears | 12 Participants | 11 Participants | 15 Participants | 38 Participants |
| Tinnitus location One ear | 4 Participants | 11 Participants | 4 Participants | 19 Participants |
| Tinnitus type of sound High frequency (hissing, sizzling, ectc.) | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Tinnitus type of sound Low frequency (buzzing, puldating, ocean, etc. | 2 Participants | 4 Participants | 1 Participants | 7 Participants |
| Tinnitus type of sound Missing | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Tinnitus type of sound Other (clicking, crickets, etc.) | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Tinnitus type of sound Tonal (ringing, music, whistling, etc.) | 47 Participants | 47 Participants | 47 Participants | 141 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 51 | 0 / 49 |
| other Total, other adverse events | 10 / 51 | 12 / 51 | 9 / 49 |
| serious Total, serious adverse events | 0 / 51 | 3 / 51 | 0 / 49 |
Outcome results
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.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Population: Intention to treat, including data from all participants with at least one follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 12 months | -21.1 units on a scale | Standard Deviation 15.1 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 3 months | -17.8 units on a scale | Standard Deviation 13.6 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 18 months | -18.2 units on a scale | Standard Deviation 15.2 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 6 months | -22.0 units on a scale | Standard Deviation 15.6 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 12 months | -21.8 units on a scale | Standard Deviation 15.9 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 6 months | -18.3 units on a scale | Standard Deviation 15.4 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 18 months | -19.0 units on a scale | Standard Deviation 15.9 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 3 months | -15.4 units on a scale | Standard Deviation 15.9 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 18 months | -16.5 units on a scale | Standard Deviation 16.3 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 3 months | -11.5 units on a scale | Standard Deviation 13.4 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 6 months | -14.5 units on a scale | Standard Deviation 14.8 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 12 months | -17.6 units on a scale | Standard Deviation 14 |
p-value: 0.4795% CI: [-8.77, 4.07]repeated measures GEE model
p-value: 0.3195% CI: [-8.27, 2.65]repeated measures GEE model
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.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Population: Intention to treat, including data from all participants with at least one follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Auditory Difficulties Sub-scale Scores. | Change from baseline to 3 months | 0.3 units on a scale | Standard Deviation 26 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Auditory Difficulties Sub-scale Scores. | Change from baseline to 6 months | -5.3 units on a scale | Standard Deviation 21.8 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Auditory Difficulties Sub-scale Scores. | Change from baseline to 12 months | -7.9 units on a scale | Standard Deviation 24.3 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Auditory Difficulties Sub-scale Scores. | Change from baseline to 18 months | -7.1 units on a scale | Standard Deviation 21.1 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Auditory Difficulties Sub-scale Scores. | Change from baseline to 18 months | -6.6 units on a scale | Standard Deviation 22.3 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Auditory Difficulties Sub-scale Scores. | Change from baseline to 3 months | -8.9 units on a scale | Standard Deviation 24.5 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Auditory Difficulties Sub-scale Scores. | Change from baseline to 12 months | -13.2 units on a scale | Standard Deviation 24.9 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Auditory Difficulties Sub-scale Scores. | Change from baseline to 6 months | -3.8 units on a scale | Standard Deviation 28.3 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Auditory Difficulties Sub-scale Scores. | Change from baseline to 18 months | -2.7 units on a scale | Standard Deviation 29.2 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Auditory Difficulties Sub-scale Scores. | Change from baseline to 6 months | -2.5 units on a scale | Standard Deviation 33.7 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Auditory Difficulties Sub-scale Scores. | Change from baseline to 12 months | -11.8 units on a scale | Standard Deviation 29.2 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Auditory Difficulties Sub-scale Scores. | Change from baseline to 3 months | 1.2 units on a scale | Standard Deviation 21.3 |
p-value: 0.3495% CI: [-3.96, 11.38]repeated measures GEE model
p-value: 0.9595% CI: [-7.72, 7.26]repeated measures GEE model
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.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Population: Intention to treat, including data from all participants with at least one follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Cognitive Interference Sub-scale Scores. | Change from baseline to 3 months | -2.2 units on a scale | Standard Deviation 20 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Cognitive Interference Sub-scale Scores. | Change from baseline to 6 months | -7.5 units on a scale | Standard Deviation 17.3 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Cognitive Interference Sub-scale Scores. | Change from baseline to 12 months | -2.4 units on a scale | Standard Deviation 21.4 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Cognitive Interference Sub-scale Scores. | Change from baseline to 18 months | -1.1 units on a scale | Standard Deviation 22.2 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Cognitive Interference Sub-scale Scores. | Change from baseline to 18 months | -14.7 units on a scale | Standard Deviation 21.2 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Cognitive Interference Sub-scale Scores. | Change from baseline to 3 months | -13.1 units on a scale | Standard Deviation 22.5 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Cognitive Interference Sub-scale Scores. | Change from baseline to 12 months | -15.4 units on a scale | Standard Deviation 21.4 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Cognitive Interference Sub-scale Scores. | Change from baseline to 6 months | -12.2 units on a scale | Standard Deviation 23.3 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Cognitive Interference Sub-scale Scores. | Change from baseline to 18 months | -8.3 units on a scale | Standard Deviation 29.2 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Cognitive Interference Sub-scale Scores. | Change from baseline to 6 months | -6.7 units on a scale | Standard Deviation 22.4 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Cognitive Interference Sub-scale Scores. | Change from baseline to 12 months | -9.1 units on a scale | Standard Deviation 24.5 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Cognitive Interference Sub-scale Scores. | Change from baseline to 3 months | -3.0 units on a scale | Standard Deviation 21.2 |
p-value: 0.6895% CI: [-5.2, 8.02]repeated measures GEE model
p-value: 0.7795% CI: [-5.44, 7.33]repeated measures GEE model
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.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Population: Intention to treat, including data from all participants with at least one follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Emotional Distress Sub-scale Scores. | Change from baseline to 3 months | -6.5 units on a scale | Standard Deviation 18.7 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Emotional Distress Sub-scale Scores. | Change from baseline to 6 months | -12.4 units on a scale | Standard Deviation 25.6 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Emotional Distress Sub-scale Scores. | Change from baseline to 12 months | -7.1 units on a scale | Standard Deviation 25 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Emotional Distress Sub-scale Scores. | Change from baseline to 18 months | -7.5 units on a scale | Standard Deviation 25.7 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Emotional Distress Sub-scale Scores. | Change from baseline to 18 months | -15.9 units on a scale | Standard Deviation 23.5 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Emotional Distress Sub-scale Scores. | Change from baseline to 3 months | -11.4 units on a scale | Standard Deviation 22.1 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Emotional Distress Sub-scale Scores. | Change from baseline to 12 months | -18.2 units on a scale | Standard Deviation 22.1 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Emotional Distress Sub-scale Scores. | Change from baseline to 6 months | -9.4 units on a scale | Standard Deviation 19.8 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Emotional Distress Sub-scale Scores. | Change from baseline to 18 months | -8.8 units on a scale | Standard Deviation 28.6 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Emotional Distress Sub-scale Scores. | Change from baseline to 6 months | -10.0 units on a scale | Standard Deviation 26.1 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Emotional Distress Sub-scale Scores. | Change from baseline to 12 months | -16.9 units on a scale | Standard Deviation 22.7 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Emotional Distress Sub-scale Scores. | Change from baseline to 3 months | -8.1 units on a scale | Standard Deviation 16.7 |
p-value: 0.9795% CI: [-6.78, 6.52]repeated measures GEE model
p-value: 0.3695% CI: [-9.43, 3.4]repeated measures GEE model
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.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Population: Intention to treat, including data from all participants with at least one follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Intrusiveness Sub-scale Scores. | Change from baseline to 3 months | -1.9 units on a scale | Standard Deviation 21.7 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Intrusiveness Sub-scale Scores. | Change from baseline to 6 months | -11.9 units on a scale | Standard Deviation 17.9 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Intrusiveness Sub-scale Scores. | Change from baseline to 12 months | -8.1 units on a scale | Standard Deviation 26.2 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Intrusiveness Sub-scale Scores. | Change from baseline to 18 months | -6.8 units on a scale | Standard Deviation 27.8 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Intrusiveness Sub-scale Scores. | Change from baseline to 18 months | -10.1 units on a scale | Standard Deviation 20.6 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Intrusiveness Sub-scale Scores. | Change from baseline to 3 months | -6.3 units on a scale | Standard Deviation 19.7 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Intrusiveness Sub-scale Scores. | Change from baseline to 12 months | -16.6 units on a scale | Standard Deviation 21.3 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Intrusiveness Sub-scale Scores. | Change from baseline to 6 months | -8.8 units on a scale | Standard Deviation 22.2 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Intrusiveness Sub-scale Scores. | Change from baseline to 18 months | -11.4 units on a scale | Standard Deviation 26.4 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Intrusiveness Sub-scale Scores. | Change from baseline to 6 months | -10.4 units on a scale | Standard Deviation 21.7 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Intrusiveness Sub-scale Scores. | Change from baseline to 12 months | -19.4 units on a scale | Standard Deviation 25.2 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Intrusiveness Sub-scale Scores. | Change from baseline to 3 months | -2.9 units on a scale | Standard Deviation 17.9 |
p-value: 0.395% CI: [-9.27, 2.88]repeated measures GEE model
p-value: 0.7695% CI: [-6.75, 4.93]repeated measures GEE model
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.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Population: Intention to treat, including data from all participants with at least one follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Reduced Quality of Life Sub-scale Scores. | Change from baseline to 3 months | -4.6 units on a scale | Standard Deviation 19.3 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Reduced Quality of Life Sub-scale Scores. | Change from baseline to 6 months | -7.0 units on a scale | Standard Deviation 18 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Reduced Quality of Life Sub-scale Scores. | Change from baseline to 12 months | -3.7 units on a scale | Standard Deviation 22.9 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Reduced Quality of Life Sub-scale Scores. | Change from baseline to 18 months | -0.3 units on a scale | Standard Deviation 23 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Reduced Quality of Life Sub-scale Scores. | Change from baseline to 18 months | -16.6 units on a scale | Standard Deviation 20.9 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Reduced Quality of Life Sub-scale Scores. | Change from baseline to 3 months | -12.0 units on a scale | Standard Deviation 21.2 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Reduced Quality of Life Sub-scale Scores. | Change from baseline to 12 months | -16.8 units on a scale | Standard Deviation 21.7 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Reduced Quality of Life Sub-scale Scores. | Change from baseline to 6 months | -10.7 units on a scale | Standard Deviation 20.9 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Reduced Quality of Life Sub-scale Scores. | Change from baseline to 18 months | -6.4 units on a scale | Standard Deviation 24.4 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Reduced Quality of Life Sub-scale Scores. | Change from baseline to 6 months | -7.6 units on a scale | Standard Deviation 23.7 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Reduced Quality of Life Sub-scale Scores. | Change from baseline to 12 months | -12.8 units on a scale | Standard Deviation 22.8 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Reduced Quality of Life Sub-scale Scores. | Change from baseline to 3 months | -4.6 units on a scale | Standard Deviation 15.5 |
p-value: 0.6895% CI: [-4.67, 7.14]repeated measures GEE model
p-value: 0.2395% CI: [-9.26, 2.23]repeated measures GEE model
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.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Population: Intention to treat, including data from all participants with at least one follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Reduced Sense of Control Sub-scale Scores. | Change from baseline to 3 months | 0.2 units on a scale | Standard Deviation 19 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Reduced Sense of Control Sub-scale Scores. | Change from baseline to 6 months | -8.0 units on a scale | Standard Deviation 18.5 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Reduced Sense of Control Sub-scale Scores. | Change from baseline to 12 months | -6.6 units on a scale | Standard Deviation 20.1 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Reduced Sense of Control Sub-scale Scores. | Change from baseline to 18 months | -9.0 units on a scale | Standard Deviation 21.5 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Reduced Sense of Control Sub-scale Scores. | Change from baseline to 18 months | -12.0 units on a scale | Standard Deviation 24 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Reduced Sense of Control Sub-scale Scores. | Change from baseline to 3 months | -9.2 units on a scale | Standard Deviation 23.6 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Reduced Sense of Control Sub-scale Scores. | Change from baseline to 12 months | -20.8 units on a scale | Standard Deviation 25.1 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Reduced Sense of Control Sub-scale Scores. | Change from baseline to 6 months | -7.0 units on a scale | Standard Deviation 24.9 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Reduced Sense of Control Sub-scale Scores. | Change from baseline to 18 months | -20.5 units on a scale | Standard Deviation 27.6 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Reduced Sense of Control Sub-scale Scores. | Change from baseline to 6 months | -12.4 units on a scale | Standard Deviation 22.1 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Reduced Sense of Control Sub-scale Scores. | Change from baseline to 12 months | -25.3 units on a scale | Standard Deviation 24.7 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Reduced Sense of Control Sub-scale Scores. | Change from baseline to 3 months | -9.4 units on a scale | Standard Deviation 17 |
p-value: 0.3595% CI: [-3.44, 9.68]repeated measures GEE model
p-value: 0.395% CI: [-2.96, 9.54]repeated measures GEE model
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.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Population: Intention to treat, including data from all participants with at least one follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Relaxation Interference Sub-scale Scores. | Change from baseline to 3 months | -7.6 units on a scale | Standard Deviation 24.3 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Relaxation Interference Sub-scale Scores. | Change from baseline to 6 months | -12.8 units on a scale | Standard Deviation 18.5 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Relaxation Interference Sub-scale Scores. | Change from baseline to 12 months | -16.1 units on a scale | Standard Deviation 23.5 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Relaxation Interference Sub-scale Scores. | Change from baseline to 18 months | -13.3 units on a scale | Standard Deviation 26.7 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Relaxation Interference Sub-scale Scores. | Change from baseline to 18 months | -18.6 units on a scale | Standard Deviation 30.2 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Relaxation Interference Sub-scale Scores. | Change from baseline to 3 months | -12.9 units on a scale | Standard Deviation 26.7 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Relaxation Interference Sub-scale Scores. | Change from baseline to 12 months | -16.3 units on a scale | Standard Deviation 28.1 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Relaxation Interference Sub-scale Scores. | Change from baseline to 6 months | -12.8 units on a scale | Standard Deviation 27.8 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Relaxation Interference Sub-scale Scores. | Change from baseline to 18 months | -15.6 units on a scale | Standard Deviation 33.1 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Relaxation Interference Sub-scale Scores. | Change from baseline to 6 months | -9.6 units on a scale | Standard Deviation 24.9 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Relaxation Interference Sub-scale Scores. | Change from baseline to 12 months | -20.3 units on a scale | Standard Deviation 33.5 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Relaxation Interference Sub-scale Scores. | Change from baseline to 3 months | -4.6 units on a scale | Standard Deviation 24.8 |
p-value: 0.6295% CI: [-9.07, 5.38]repeated measures GEE model
p-value: 0.2195% CI: [-11.48, 2.55]repeated measures GEE model
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.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Population: Intention to treat, including data from all participants with at least one follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Sleep Disturbance Sub-scale Scores. | Change from baseline to 3 months | -7.2 units on a scale | Standard Deviation 23.9 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Sleep Disturbance Sub-scale Scores. | Change from baseline to 6 months | -13.0 units on a scale | Standard Deviation 27.3 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Sleep Disturbance Sub-scale Scores. | Change from baseline to 12 months | -10.9 units on a scale | Standard Deviation 27.7 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index Sleep Disturbance Sub-scale Scores. | Change from baseline to 18 months | -11.1 units on a scale | Standard Deviation 31.4 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Sleep Disturbance Sub-scale Scores. | Change from baseline to 18 months | -20.2 units on a scale | Standard Deviation 23.4 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Sleep Disturbance Sub-scale Scores. | Change from baseline to 3 months | -16.1 units on a scale | Standard Deviation 24.9 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Sleep Disturbance Sub-scale Scores. | Change from baseline to 12 months | -20.6 units on a scale | Standard Deviation 26.9 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index Sleep Disturbance Sub-scale Scores. | Change from baseline to 6 months | -10.8 units on a scale | Standard Deviation 28.4 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Sleep Disturbance Sub-scale Scores. | Change from baseline to 18 months | -10.0 units on a scale | Standard Deviation 24.3 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Sleep Disturbance Sub-scale Scores. | Change from baseline to 6 months | -11.2 units on a scale | Standard Deviation 23.5 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Sleep Disturbance Sub-scale Scores. | Change from baseline to 12 months | -15.9 units on a scale | Standard Deviation 29 |
| Standard of Care (SC) | Change in Tinnitus Functional Index Sleep Disturbance Sub-scale Scores. | Change from baseline to 3 months | -4.0 units on a scale | Standard Deviation 21.1 |
p-value: 0.4395% CI: [-12.3, 5.23]repeated measures GEE model
p-value: 0.00195% CI: [-22.02, -5.38]repeated measures GEE model
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.
Time frame: Baseline and 3, 6, 12, and 18 months
Population: Intention to treat, including data from all participants with at least one follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index (TFI) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 3 months | -3.7 units on a scale | Standard Deviation 15.3 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index (TFI) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 6 months | -9.6 units on a scale | Standard Deviation 14.2 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index (TFI) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 12 months | -7.7 units on a scale | Standard Deviation 18.6 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Functional Index (TFI) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 18 months | -6.7 units on a scale | Standard Deviation 18.5 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index (TFI) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 18 months | -14.4 units on a scale | Standard Deviation 17.2 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index (TFI) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 3 months | -10.9 units on a scale | Standard Deviation 18 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index (TFI) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 12 months | -17.2 units on a scale | Standard Deviation 17.7 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Functional Index (TFI) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 6 months | -9.5 units on a scale | Standard Deviation 18.6 |
| Standard of Care (SC) | Change in Tinnitus Functional Index (TFI) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 18 months | -10.3 units on a scale | Standard Deviation 21.9 |
| Standard of Care (SC) | Change in Tinnitus Functional Index (TFI) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 6 months | -8.7 units on a scale | Standard Deviation 18 |
| Standard of Care (SC) | Change in Tinnitus Functional Index (TFI) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 12 months | -16.3 units on a scale | Standard Deviation 19.2 |
| Standard of Care (SC) | Change in Tinnitus Functional Index (TFI) From Baseline to 3, 6, 12, and 18 Months | Change from baseline to 3 months | -4.4 units on a scale | Standard Deviation 12.7 |
p-value: 0.9695% CI: [-5.3, 5.02]repeated measures GEE model
p-value: 0.2895% CI: [-2.21, 7.7]repeated measures GEE model
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.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Population: Intention to treat, including data from all participants with at least one follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Handicap Inventory Catastrophic Sub-scale Scores. | Change from baseline to 3 months | -1.7 units on a scale | Standard Deviation 3.6 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Handicap Inventory Catastrophic Sub-scale Scores. | Change from baseline to 6 months | -3.0 units on a scale | Standard Deviation 3.3 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Handicap Inventory Catastrophic Sub-scale Scores. | Change from baseline to 12 months | -1.9 units on a scale | Standard Deviation 4.1 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Handicap Inventory Catastrophic Sub-scale Scores. | Change from baseline to 18 months | -1.7 units on a scale | Standard Deviation 3.8 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Handicap Inventory Catastrophic Sub-scale Scores. | Change from baseline to 18 months | -3.2 units on a scale | Standard Deviation 4.4 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Handicap Inventory Catastrophic Sub-scale Scores. | Change from baseline to 3 months | -3.2 units on a scale | Standard Deviation 4.8 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Handicap Inventory Catastrophic Sub-scale Scores. | Change from baseline to 12 months | -3.5 units on a scale | Standard Deviation 4.7 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Handicap Inventory Catastrophic Sub-scale Scores. | Change from baseline to 6 months | -2.7 units on a scale | Standard Deviation 4.7 |
| Standard of Care (SC) | Change in Tinnitus Handicap Inventory Catastrophic Sub-scale Scores. | Change from baseline to 18 months | -2.7 units on a scale | Standard Deviation 4.3 |
| Standard of Care (SC) | Change in Tinnitus Handicap Inventory Catastrophic Sub-scale Scores. | Change from baseline to 6 months | -1.8 units on a scale | Standard Deviation 4.9 |
| Standard of Care (SC) | Change in Tinnitus Handicap Inventory Catastrophic Sub-scale Scores. | Change from baseline to 12 months | -2.7 units on a scale | Standard Deviation 3.2 |
| Standard of Care (SC) | Change in Tinnitus Handicap Inventory Catastrophic Sub-scale Scores. | Change from baseline to 3 months | -1.8 units on a scale | Standard Deviation 3.4 |
p-value: 0.395% CI: [0.55, 1.78]repeated measures GEE model
p-value: 0.2995% CI: [-1.75, 0.52]repeated measures GEE model
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.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Population: Intention to treat, including data from all participants with at least one follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Handicap Inventory Emotional Sub-scale Scores. | Change from baseline to 3 months | -3.0 units on a scale | Standard Deviation 6.7 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Handicap Inventory Emotional Sub-scale Scores. | Change from baseline to 6 months | -4.1 units on a scale | Standard Deviation 5.9 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Handicap Inventory Emotional Sub-scale Scores. | Change from baseline to 12 months | -3.3 units on a scale | Standard Deviation 7.1 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Handicap Inventory Emotional Sub-scale Scores. | Change from baseline to 18 months | -2.8 units on a scale | Standard Deviation 8 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Handicap Inventory Emotional Sub-scale Scores. | Change from baseline to 18 months | -4.4 units on a scale | Standard Deviation 7.7 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Handicap Inventory Emotional Sub-scale Scores. | Change from baseline to 3 months | -4.2 units on a scale | Standard Deviation 6.9 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Handicap Inventory Emotional Sub-scale Scores. | Change from baseline to 12 months | -4.9 units on a scale | Standard Deviation 6.3 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Handicap Inventory Emotional Sub-scale Scores. | Change from baseline to 6 months | -4.2 units on a scale | Standard Deviation 7.3 |
| Standard of Care (SC) | Change in Tinnitus Handicap Inventory Emotional Sub-scale Scores. | Change from baseline to 18 months | -4.3 units on a scale | Standard Deviation 6.2 |
| Standard of Care (SC) | Change in Tinnitus Handicap Inventory Emotional Sub-scale Scores. | Change from baseline to 6 months | -2.4 units on a scale | Standard Deviation 8.5 |
| Standard of Care (SC) | Change in Tinnitus Handicap Inventory Emotional Sub-scale Scores. | Change from baseline to 12 months | -5.3 units on a scale | Standard Deviation 6.3 |
| Standard of Care (SC) | Change in Tinnitus Handicap Inventory Emotional Sub-scale Scores. | Change from baseline to 3 months | -1.7 units on a scale | Standard Deviation 5.4 |
p-value: 0.7295% CI: [-1.54, 2.23]repeated measures GEE model
p-value: 0.2695% CI: [-2.83, 0.75]repeated measures GEE model
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.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Population: Intention to treat, including data from all participants with at least one follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Handicap Inventory Functional Sub-scale Scores. | Change from baseline to 3 months | -1.3 units on a scale | Standard Deviation 7.9 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Handicap Inventory Functional Sub-scale Scores. | Change from baseline to 6 months | -3.2 units on a scale | Standard Deviation 6.4 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Handicap Inventory Functional Sub-scale Scores. | Change from baseline to 12 months | -2.2 units on a scale | Standard Deviation 7.2 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Handicap Inventory Functional Sub-scale Scores. | Change from baseline to 18 months | -1.5 units on a scale | Standard Deviation 8.7 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Handicap Inventory Functional Sub-scale Scores. | Change from baseline to 18 months | -5.1 units on a scale | Standard Deviation 7 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Handicap Inventory Functional Sub-scale Scores. | Change from baseline to 3 months | -6.2 units on a scale | Standard Deviation 8.7 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Handicap Inventory Functional Sub-scale Scores. | Change from baseline to 12 months | -6.6 units on a scale | Standard Deviation 7.5 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Handicap Inventory Functional Sub-scale Scores. | Change from baseline to 6 months | -4.1 units on a scale | Standard Deviation 9 |
| Standard of Care (SC) | Change in Tinnitus Handicap Inventory Functional Sub-scale Scores. | Change from baseline to 18 months | -2.4 units on a scale | Standard Deviation 9.7 |
| Standard of Care (SC) | Change in Tinnitus Handicap Inventory Functional Sub-scale Scores. | Change from baseline to 6 months | -1.2 units on a scale | Standard Deviation 9.3 |
| Standard of Care (SC) | Change in Tinnitus Handicap Inventory Functional Sub-scale Scores. | Change from baseline to 12 months | -4.0 units on a scale | Standard Deviation 8 |
| Standard of Care (SC) | Change in Tinnitus Handicap Inventory Functional Sub-scale Scores. | Change from baseline to 3 months | 0.5 units on a scale | Standard Deviation 7.5 |
p-value: 0.5295% CI: [-3.3, 1.66]repeated measures GEE model
p-value: 0.02295% CI: [-5.21, -0.41]repeated measures GEE model
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.
Time frame: Baseline and 3. 6. 12. and 18 months
Population: Intention to treat, including data from all participants with at least one follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Handicap Inventory (THI) Score From Baseline to 3, 6, 12, and 18 Months Follow-up | Change from baseline to 3 months | -6.0 units on a scale | Standard Deviation 15.8 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Handicap Inventory (THI) Score From Baseline to 3, 6, 12, and 18 Months Follow-up | Change from baseline to 6 months | -10.3 units on a scale | Standard Deviation 12.8 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Handicap Inventory (THI) Score From Baseline to 3, 6, 12, and 18 Months Follow-up | Change from baseline to 12 months | -7.4 units on a scale | Standard Deviation 16.3 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Handicap Inventory (THI) Score From Baseline to 3, 6, 12, and 18 Months Follow-up | Change from baseline to 18 months | -6.1 units on a scale | Standard Deviation 18 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Handicap Inventory (THI) Score From Baseline to 3, 6, 12, and 18 Months Follow-up | Change from baseline to 18 months | -12.6 units on a scale | Standard Deviation 17.1 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Handicap Inventory (THI) Score From Baseline to 3, 6, 12, and 18 Months Follow-up | Change from baseline to 3 months | -13.6 units on a scale | Standard Deviation 18.4 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Handicap Inventory (THI) Score From Baseline to 3, 6, 12, and 18 Months Follow-up | Change from baseline to 12 months | -14.9 units on a scale | Standard Deviation 17.2 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Handicap Inventory (THI) Score From Baseline to 3, 6, 12, and 18 Months Follow-up | Change from baseline to 6 months | -11.0 units on a scale | Standard Deviation 19.1 |
| Standard of Care (SC) | Change in Tinnitus Handicap Inventory (THI) Score From Baseline to 3, 6, 12, and 18 Months Follow-up | Change from baseline to 18 months | -9.4 units on a scale | Standard Deviation 17.7 |
| Standard of Care (SC) | Change in Tinnitus Handicap Inventory (THI) Score From Baseline to 3, 6, 12, and 18 Months Follow-up | Change from baseline to 6 months | -5.3 units on a scale | Standard Deviation 20.6 |
| Standard of Care (SC) | Change in Tinnitus Handicap Inventory (THI) Score From Baseline to 3, 6, 12, and 18 Months Follow-up | Change from baseline to 12 months | -12.0 units on a scale | Standard Deviation 15.5 |
| Standard of Care (SC) | Change in Tinnitus Handicap Inventory (THI) Score From Baseline to 3, 6, 12, and 18 Months Follow-up | Change from baseline to 3 months | -2.9 units on a scale | Standard Deviation 13.6 |
p-value: 0.395% CI: [-0.55, 1.77]repeated measures GEE model
p-value: 0.2995% CI: [-1.75, 0.52]repeated measures GEE model
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.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Population: Intention to treat, including all data from participants with at least one follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire Auditory Perceptual Difficulties Sub-scale Scores. | Change from baseline to 3 months | -2.5 units on a scale | Standard Deviation 2.6 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire Auditory Perceptual Difficulties Sub-scale Scores. | Change from baseline to 6 months | -2.4 units on a scale | Standard Deviation 2.9 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire Auditory Perceptual Difficulties Sub-scale Scores. | Change from baseline to 12 months | -2.6 units on a scale | Standard Deviation 2.4 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire Auditory Perceptual Difficulties Sub-scale Scores. | Change from baseline to 18 months | -2.0 units on a scale | Standard Deviation 3 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire Auditory Perceptual Difficulties Sub-scale Scores. | Change from baseline to 18 months | -2.0 units on a scale | Standard Deviation 3.2 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire Auditory Perceptual Difficulties Sub-scale Scores. | Change from baseline to 3 months | -1.8 units on a scale | Standard Deviation 3 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire Auditory Perceptual Difficulties Sub-scale Scores. | Change from baseline to 12 months | -2.3 units on a scale | Standard Deviation 2.9 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire Auditory Perceptual Difficulties Sub-scale Scores. | Change from baseline to 6 months | -2.4 units on a scale | Standard Deviation 2.6 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire Auditory Perceptual Difficulties Sub-scale Scores. | Change from baseline to 18 months | -2.4 units on a scale | Standard Deviation 3.2 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire Auditory Perceptual Difficulties Sub-scale Scores. | Change from baseline to 6 months | -2.1 units on a scale | Standard Deviation 3.2 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire Auditory Perceptual Difficulties Sub-scale Scores. | Change from baseline to 12 months | -2.6 units on a scale | Standard Deviation 3 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire Auditory Perceptual Difficulties Sub-scale Scores. | Change from baseline to 3 months | -1.2 units on a scale | Standard Deviation 2.5 |
p-value: 0.4895% CI: [-1.35, 0.64]repeated measures GEE model
p-value: 0.4695% CI: [-1.37, 0.62]repeated measures GEE model
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.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Population: Intention to treat, including data from all participants with at least one follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire Emotional Distress Sub-scale Scores From Baseline to 3, 6, 12, and 18 Months. | Change from baseline to 3 months | -7.2 units on a scale | Standard Deviation 6.3 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire Emotional Distress Sub-scale Scores From Baseline to 3, 6, 12, and 18 Months. | Change from baseline to 6 months | -8.8 units on a scale | Standard Deviation 6.8 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire Emotional Distress Sub-scale Scores From Baseline to 3, 6, 12, and 18 Months. | Change from baseline to 12 months | -8.9 units on a scale | Standard Deviation 6.4 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire Emotional Distress Sub-scale Scores From Baseline to 3, 6, 12, and 18 Months. | Change from baseline to 18 months | -8.1 units on a scale | Standard Deviation 6.3 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire Emotional Distress Sub-scale Scores From Baseline to 3, 6, 12, and 18 Months. | Change from baseline to 18 months | -8.7 units on a scale | Standard Deviation 7.9 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire Emotional Distress Sub-scale Scores From Baseline to 3, 6, 12, and 18 Months. | Change from baseline to 3 months | -6.6 units on a scale | Standard Deviation 8 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire Emotional Distress Sub-scale Scores From Baseline to 3, 6, 12, and 18 Months. | Change from baseline to 12 months | -9.0 units on a scale | Standard Deviation 7 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire Emotional Distress Sub-scale Scores From Baseline to 3, 6, 12, and 18 Months. | Change from baseline to 6 months | -7.8 units on a scale | Standard Deviation 8.3 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire Emotional Distress Sub-scale Scores From Baseline to 3, 6, 12, and 18 Months. | Change from baseline to 18 months | -7.4 units on a scale | Standard Deviation 6.3 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire Emotional Distress Sub-scale Scores From Baseline to 3, 6, 12, and 18 Months. | Change from baseline to 6 months | -6.0 units on a scale | Standard Deviation 6.5 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire Emotional Distress Sub-scale Scores From Baseline to 3, 6, 12, and 18 Months. | Change from baseline to 12 months | -7.4 units on a scale | Standard Deviation 5.8 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire Emotional Distress Sub-scale Scores From Baseline to 3, 6, 12, and 18 Months. | Change from baseline to 3 months | -4.6 units on a scale | Standard Deviation 6.2 |
p-value: 0.7795% CI: [-3.08, 2.29]repeated measures GEE model
p-value: 0.6595% CI: [-3.16, 1.96]repeated measures GEE model
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.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Population: Intention to treat, including data from all participants with at least one follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores. | Change from baseline to 3 months | -2.4 units on a scale | Standard Deviation 3.3 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores. | Change from baseline to 6 months | -2.2 units on a scale | Standard Deviation 2.7 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores. | Change from baseline to 12 months | -3.0 units on a scale | Standard Deviation 3 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores. | Change from baseline to 18 months | -3.2 units on a scale | Standard Deviation 3.3 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores. | Change from baseline to 18 months | -2.4 units on a scale | Standard Deviation 2.9 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores. | Change from baseline to 3 months | -1.7 units on a scale | Standard Deviation 2.8 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores. | Change from baseline to 12 months | -3.1 units on a scale | Standard Deviation 3 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores. | Change from baseline to 6 months | -2.2 units on a scale | Standard Deviation 3.1 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores. | Change from baseline to 18 months | -2.4 units on a scale | Standard Deviation 3.3 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores. | Change from baseline to 6 months | -2.0 units on a scale | Standard Deviation 3.2 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores. | Change from baseline to 12 months | -2.2 units on a scale | Standard Deviation 3.3 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores. | Change from baseline to 3 months | -1.4 units on a scale | Standard Deviation 2.5 |
p-value: 0.595% CI: [-1.38, 0.67]repeated measures GEE model
p-value: 0.8295% CI: [-1.14, 0.9]repeated measures GEE model
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.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Population: Intention to treat, including data from all participants with at least one follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire Sleep Disturbance Sub-scale Scores. | Change from baseline to 3 months | -1.4 units on a scale | Standard Deviation 1.7 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire Sleep Disturbance Sub-scale Scores. | Change from baseline to 6 months | -1.7 units on a scale | Standard Deviation 2 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire Sleep Disturbance Sub-scale Scores. | Change from baseline to 12 months | -1.7 units on a scale | Standard Deviation 2.4 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire Sleep Disturbance Sub-scale Scores. | Change from baseline to 18 months | -1.6 units on a scale | Standard Deviation 2.3 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire Sleep Disturbance Sub-scale Scores. | Change from baseline to 18 months | -2.2 units on a scale | Standard Deviation 2 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire Sleep Disturbance Sub-scale Scores. | Change from baseline to 3 months | -1.9 units on a scale | Standard Deviation 2.2 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire Sleep Disturbance Sub-scale Scores. | Change from baseline to 12 months | -2.3 units on a scale | Standard Deviation 2.5 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire Sleep Disturbance Sub-scale Scores. | Change from baseline to 6 months | -1.8 units on a scale | Standard Deviation 1.9 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire Sleep Disturbance Sub-scale Scores. | Change from baseline to 18 months | -1.2 units on a scale | Standard Deviation 2.1 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire Sleep Disturbance Sub-scale Scores. | Change from baseline to 6 months | -1.2 units on a scale | Standard Deviation 1.7 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire Sleep Disturbance Sub-scale Scores. | Change from baseline to 12 months | -1.4 units on a scale | Standard Deviation 1.9 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire Sleep Disturbance Sub-scale Scores. | Change from baseline to 3 months | -1.2 units on a scale | Standard Deviation 1.7 |
p-value: 0.7595% CI: [-0.74, 0.53]repeated measures GEE model
p-value: 0.01595% CI: [-1.56, -0.17]repeated measures GEE model
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.
Time frame: Baseline to 3, 6, 12, and 18 months follow-up
Population: Intention to treat, including data from all participants with at least one follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire Somatic Complaint Sub-scale Scores. | Change from baseline to 3 months | -1.9 units on a scale | Standard Deviation 2 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire Somatic Complaint Sub-scale Scores. | Change from baseline to 6 months | -2.2 units on a scale | Standard Deviation 1.7 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire Somatic Complaint Sub-scale Scores. | Change from baseline to 12 months | -2.1 units on a scale | Standard Deviation 1.8 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Questionnaire Somatic Complaint Sub-scale Scores. | Change from baseline to 18 months | -1.7 units on a scale | Standard Deviation 1.9 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire Somatic Complaint Sub-scale Scores. | Change from baseline to 18 months | -1.5 units on a scale | Standard Deviation 2.1 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire Somatic Complaint Sub-scale Scores. | Change from baseline to 3 months | -1.2 units on a scale | Standard Deviation 1.9 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire Somatic Complaint Sub-scale Scores. | Change from baseline to 12 months | -1.7 units on a scale | Standard Deviation 2 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Questionnaire Somatic Complaint Sub-scale Scores. | Change from baseline to 6 months | -1.6 units on a scale | Standard Deviation 1.8 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire Somatic Complaint Sub-scale Scores. | Change from baseline to 18 months | -1.3 units on a scale | Standard Deviation 2.1 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire Somatic Complaint Sub-scale Scores. | Change from baseline to 6 months | -1.5 units on a scale | Standard Deviation 2 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire Somatic Complaint Sub-scale Scores. | Change from baseline to 12 months | -1.6 units on a scale | Standard Deviation 2 |
| Standard of Care (SC) | Change in Tinnitus Questionnaire Somatic Complaint Sub-scale Scores. | Change from baseline to 3 months | -1.2 units on a scale | Standard Deviation 2.1 |
p-value: 0.8595% CI: [-0.83, 0.69]repeated measures GEE model
p-value: 0.5595% CI: [-0.86, 0.46]repeated measures GEE model
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
Time frame: Baseline to 6, 12, and 18 months follow-up
Population: Intention to treat, including data from all participants with at least one follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Retraining Therapy Interview Visual Analogue Scales at 3, 6, 12, and 18 Months Follow-up | Change from baseline to 12 months | -1.9 units on a scale | Standard Deviation 2.6 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Retraining Therapy Interview Visual Analogue Scales at 3, 6, 12, and 18 Months Follow-up | Change from baseline to 6 months | -1.6 units on a scale | Standard Deviation 2.4 |
| Tinnitus Retraining Therapy (TRT) | Change in Tinnitus Retraining Therapy Interview Visual Analogue Scales at 3, 6, 12, and 18 Months Follow-up | Change from baseline to 18 months | -1.8 units on a scale | Standard Deviation 3 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Retraining Therapy Interview Visual Analogue Scales at 3, 6, 12, and 18 Months Follow-up | Change from baseline to 12 months | -2.0 units on a scale | Standard Deviation 2.6 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Retraining Therapy Interview Visual Analogue Scales at 3, 6, 12, and 18 Months Follow-up | Change from baseline to 6 months | -1.4 units on a scale | Standard Deviation 2.3 |
| Partial Tinnitus Retraining Therapy (Partial TRT) | Change in Tinnitus Retraining Therapy Interview Visual Analogue Scales at 3, 6, 12, and 18 Months Follow-up | Change from baseline to 18 months | -2.1 units on a scale | Standard Deviation 2.4 |
| Standard of Care (SC) | Change in Tinnitus Retraining Therapy Interview Visual Analogue Scales at 3, 6, 12, and 18 Months Follow-up | Change from baseline to 6 months | -1.3 units on a scale | Standard Deviation 2.6 |
| Standard of Care (SC) | Change in Tinnitus Retraining Therapy Interview Visual Analogue Scales at 3, 6, 12, and 18 Months Follow-up | Change from baseline to 18 months | -1.8 units on a scale | Standard Deviation 2.8 |
| Standard of Care (SC) | Change in Tinnitus Retraining Therapy Interview Visual Analogue Scales at 3, 6, 12, and 18 Months Follow-up | Change from baseline to 12 months | -2.1 units on a scale | Standard Deviation 2.7 |