The Clinical Effects of Modified TRS Treatment

Study Overview
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Brief Summary
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Objective Tinnitus is one of the most common acoustic disorders by affecting 5-43% people around the world, and tinnitus is harmful to social and individuals, inducing to annoyance, irritability, anxiety, depression, insomnia and concentration difficulties. Many efforts have been made to help tinnitus suffers, however, the curative means are still in absence. This study aims to introduce a novel sound therapy for tinnitus and to evaluate the efficacy of modified tinnitus relieving sound treatment in comparison with unmodified music which served as a control. Methods and analysis A randomized, triple-blinded, controlled, clinical trial will be carried out. 68 patients with subjective tinnitus will be recruited and randomized into two groups in 1:1 ratio. The primary outcomes will be Tinnitus Handicapped Inventory (THI), Hospital Anxiety and Distress Scale (HADS), and visual analogue scale (VAS) for tinnitus; the secondary outcome measures will be Athens Insomnia Scale (AIS), tinnitus loudness matched by sensation level (LM, SL), and minimum masking level (MML). Assessment will be performed at baseline and at 1, 3, 9, and 12 months post-randomization. The sound stimulus will be persistent until 9 months after randomization, and be interdictory in the last three months.

Official Title
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The Clinical Effects of Modified Tinnitus Relieving Sound Treatment

Conditions
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Tinnitus, Subjective

Intervention / Treatment
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* Other: Listening to unmodified music
* Other: Listening to modified tinnitus relieving sound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged between 18 to 80 years old; Diagnosed with subjective tinnitus; Chronic tinnitus: tinnitus course ≥3 months; Be able to understand and communicate with Mandarin； The average pure tone threshold (0.5, 1, 2kHz) ≤ 55dB HL of the worse ear; Subjects are able to understand the purpose of the study, volunteer to participate and cooperate with the instructors to complete the experiment, and be willing to sign the informed consent. Exclusion Criteria: Pulsatile tinnitus and objective tinnitus； Having significant health issues that affect or prevent participation or continue with the follow-up; Diseases requiring other medical intervention first (eg, infections, tumors, otosclerosis, Meniere's disease, the acute stage of sudden sensorineural hearing loss); People with severe hyperacusis, severe anxiety, depression and other psychiatric disorders； Currently participating in other research projects that may affect tinnitus； Subjects who are not considered suitable for this clinical trial by the researchers.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Unmodified music group<br>34 participants in Group 1 will listen to the music without any modification for at least two hours a day in total. | Other: Listening to unmodified music<br>* Listening to unmodified music for at least 2 hours a day<br>|
| Experimental: Modified tinnitus relieving sound group<br>34 participants in Group 2 will listen to the music modified according to the matched dominant tinnitus pitch for at least two hours a day in total. | Other: Listening to modified tinnitus relieving sound<br>* Listening to modified tinnitus relieving sound for at least 2 hours a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Handicapped Inventory (THI) | THI is a self-assessment inventory including 25 items with grades four categories of tinnitus severity: slight corresponding to a score 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus. | 1 months from baseline | 
| Tinnitus Handicapped Inventory (THI) | THI is a self-assessment inventory including 25 items with grades four categories of tinnitus severity: slight corresponding to a score 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus. | 3 months from baseline | 
| Tinnitus Handicapped Inventory (THI) | THI is a self-assessment inventory including 25 items with grades four categories of tinnitus severity: slight corresponding to a score 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus. | 9 months from baseline | 
| Tinnitus Handicapped Inventory (THI) | THI is a self-assessment inventory including 25 items with grades four categories of tinnitus severity: slight corresponding to a score 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus. | 12 months from baseline | 
| Hospital Anxiety and Distress Scale (HADS) | HADS includes two subscales for anxiety and depression, each with respective 7 items, and the grades are valued by scoring: negative (0-7), positive (8-21). | 1 months from baseline | 
| Hospital Anxiety and Distress Scale (HADS) | HADS includes two subscales for anxiety and depression, each with respective 7 items, and the grades are valued by scoring: negative (0-7), positive (8-21). | 3 months from baseline | 
| Hospital Anxiety and Distress Scale (HADS) | HADS includes two subscales for anxiety and depression, each with respective 7 items, and the grades are valued by scoring: negative (0-7), positive (8-21). | 9 months from baseline | 
| Hospital Anxiety and Distress Scale (HADS) | HADS includes two subscales for anxiety and depression, each with respective 7 items, and the grades are valued by scoring: negative (0-7), positive (8-21). | 12 months from baseline | 
| Visual Analogue Scale (VAS) for tinnitus | Visual Analogue Scale (VAS) for tinnitus is a universal psychometric scale evaluating subjective tinnintus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom. | 1 months from baseline | 
| Visual Analogue Scale (VAS) for tinnitus | Visual Analogue Scale (VAS) for tinnitus is a universal psychometric scale evaluating subjective tinnintus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom. | 3 months from baseline | 
| Visual Analogue Scale (VAS) for tinnitus | Visual Analogue Scale (VAS) for tinnitus is a universal psychometric scale evaluating subjective tinnintus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom. | 9 months from baseline | 
| Visual Analogue Scale (VAS) for tinnitus | Visual Analogue Scale (VAS) for tinnitus is a universal psychometric scale evaluating subjective tinnintus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom. | 12 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Athens Insomnia Scale (AIS) | AIS grades three categories of sleep disorder: no insomnia scoring below 4, suspicious (4-6), insomnia (7-24) | 1 months from baseline | 
| Athens Insomnia Scale (AIS) | AIS grades three categories of sleep disorder: no insomnia scoring below 4, suspicious (4-6), insomnia (7-24) | 3 months from baseline | 
| Athens Insomnia Scale (AIS) | AIS grades three categories of sleep disorder: no insomnia scoring below 4, suspicious (4-6), insomnia (7-24) | 9 months from baseline | 
| Athens Insomnia Scale (AIS) | AIS grades three categories of sleep disorder: no insomnia scoring below 4, suspicious (4-6), insomnia (7-24) | 12 months from baseline | 
| tinnitus loudness matched by sensation level (LM, SL) | The loudness of tinnitus is reflected in sensation level (dB SL). Sensation level is defined as the loudness value above hearing threshold at the pitch of tinnitus. | 1 months from baseline | 
| tinnitus loudness matched by sensation level (LM, SL) | The loudness of tinnitus is reflected in sensation level (dB SL). Sensation level is defined as the loudness value above hearing threshold at the pitch of tinnitus. | 3 months from baseline | 
| tinnitus loudness matched by sensation level (LM, SL) | The loudness of tinnitus is reflected in sensation level (dB SL). Sensation level is defined as the loudness value above hearing threshold at the pitch of tinnitus. | 9 months from baseline | 
| tinnitus loudness matched by sensation level (LM, SL) | The loudness of tinnitus is reflected in sensation level (dB SL). Sensation level is defined as the loudness value above hearing threshold at the pitch of tinnitus. | 12 months from baseline | 
| minimum masking level (MML) | MML test is presented bilaterally, the noise is raised until tinnitus is just covered in both ears. The higher the value, the more severe the tinnitus. | 1 months from baseline | 
| minimum masking level (MML) | MML test is presented bilaterally, the noise is raised until tinnitus is just covered in both ears. The higher the value, the more severe the tinnitus. | 3 months from baseline | 
| minimum masking level (MML) | MML test is presented bilaterally, the noise is raised until tinnitus is just covered in both ears. The higher the value, the more severe the tinnitus. | 9 months from baseline | 
| minimum masking level (MML) | MML test is presented bilaterally, the noise is raised until tinnitus is just covered in both ears. The higher the value, the more severe the tinnitus. | 12 months from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subjective tinnitus, tinnitus relieving sound, clinical effects