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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unmodified music group | Placebo Comparator | 34 participants in Group 1 will listen to the music without any modification for at least two hours a day in total. |
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| Modified tinnitus relieving sound group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Listening to unmodified music | Other | Listening to unmodified music for at least 2 hours a day |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongmei Tang | Contact | +86-13023299189 | tang.dongm@163.com | |
| Huiqian Yu | Contact | +86-13636423139 | yhq925@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Huawei Li | Eye and ENT Hospital of Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China | Shanghai | Shanghai Municipality | 200031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23948178 | Background | Langguth B, Kreuzer PM, Kleinjung T, De Ridder D. Tinnitus: causes and clinical management. Lancet Neurol. 2013 Sep;12(9):920-930. doi: 10.1016/S1474-4422(13)70160-1. | |
| 21502503 | Background | De Ridder D, Elgoyhen AB, Romo R, Langguth B. Phantom percepts: tinnitus and pain as persisting aversive memory networks. Proc Natl Acad Sci U S A. 2011 May 17;108(20):8075-80. doi: 10.1073/pnas.1018466108. Epub 2011 Apr 18. |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| Listening to modified tinnitus relieving sound | Other | Listening to modified tinnitus relieving sound for at least 2 hours a day |
|
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 |
| 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 |
| 25273878 | Background | Tunkel DE, Bauer CA, Sun GH, Rosenfeld RM, Chandrasekhar SS, Cunningham ER Jr, Archer SM, Blakley BW, Carter JM, Granieri EC, Henry JA, Hollingsworth D, Khan FA, Mitchell S, Monfared A, Newman CW, Omole FS, Phillips CD, Robinson SK, Taw MB, Tyler RS, Waguespack R, Whamond EJ. Clinical practice guideline: tinnitus. Otolaryngol Head Neck Surg. 2014 Oct;151(2 Suppl):S1-S40. doi: 10.1177/0194599814545325. |
| 22633033 | Background | Cima RF, Maes IH, Joore MA, Scheyen DJ, El Refaie A, Baguley DM, Anteunis LJ, van Breukelen GJ, Vlaeyen JW. Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: a randomised controlled trial. Lancet. 2012 May 26;379(9830):1951-9. doi: 10.1016/S0140-6736(12)60469-3. |
| 8630207 | Background | Newman CW, Jacobson GP, Spitzer JB. Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1996 Feb;122(2):143-8. doi: 10.1001/archotol.1996.01890140029007. |
| 37268971 | Derived | Tang D, Wang J, Yu X, Yu H. The clinical effects of modified tinnitus relieving sound (MTRS) for chronic tinnitus: protocol for a randomized controlled trial. Trials. 2023 Jun 2;24(1):372. doi: 10.1186/s13063-023-07389-8. |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |