Combination of Electroacupuncture and Medication for Patients With Tinnitus Associated With Idiopathic Sudden Sensorineural Hearing Loss: Protocol for a Prospective Randomized Controlled Trial
BackgroundTinnitus, a common and troublesome symptom of idiopathic sudden sensorineural hearing loss (ISSNHL), is the perception of sound without any external or internal sound source. The etiology of ISSNHL accompanied by tinnitus remains unclear. Tinnitus often occurs along...
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JMIR Publications
2025-05-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2025/1/e69163 |
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| author | Tuoran Wang Lingyu Qi Xinping Hao Miao Zhang Shihao Du Biao Chen Chang Liu Jing Chen Xinyue Zou Ping Liu Jin Huo |
| author_facet | Tuoran Wang Lingyu Qi Xinping Hao Miao Zhang Shihao Du Biao Chen Chang Liu Jing Chen Xinyue Zou Ping Liu Jin Huo |
| author_sort | Tuoran Wang |
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BackgroundTinnitus, a common and troublesome symptom of idiopathic sudden sensorineural hearing loss (ISSNHL), is the perception of sound without any external or internal sound source. The etiology of ISSNHL accompanied by tinnitus remains unclear. Tinnitus often occurs alongside or before hearing loss and can severely impact patients’ quality of life, leading to psychological stress and emotional distress. Current treatments primarily focus on improving hearing loss while neglecting tinnitus treatment. Electroacupuncture (EA), a technique widely applied in China for tinnitus management, may become a promising intervention by addressing both auditory and psychological symptoms.
ObjectiveThis study aims to conduct a double-center, assessor-blinded, prospective randomized pilot clinical trial to explore the potential effects and feasibility of EA combined with medication for patients with ISSNHL accompanied by tinnitus, and to generate preliminary data to inform future large-scale trials of EA as an adjunctive therapy for this condition.
MethodsIn this double-center, assessor-blinded, randomized controlled trial, 60 patients with ISSNHL accompanied by tinnitus will be randomly allocated to either the EA group, receiving EA combined with medication, or the control group, receiving standard medication treatment, for a total treatment duration of 4 weeks. Follow-up assessments will be conducted at weeks 2 and 4, and at 1, 2, and 3 months after treatment. The feasibility primary outcomes are recruitment rate, adherence rate, data completeness, and safety outcomes. The primary outcome measures will include pure tone audiometry, tinnitus matching, and the Tinnitus Handicap Inventory, while the secondary outcome measures will comprise speech-recognition thresholds in noise, the Self-Rating Anxiety Scale, and the 36-item Short Form Health Survey Questionnaire.
ResultsThis study began recruitment on July 15, 2024, and is scheduled to conclude on August 31, 2025. To date, 42 participants have been enrolled, with 35 having completed the intervention and posttreatment assessments (control group: n=21; EA group: n=14). Following protocol publication, data compilation and analysis will be conducted, with results anticipated to be published in a relevant journal in 2026.
ConclusionsThis pilot trial is expected to provide critical insights into the feasibility of integrating EA with standard medication for managing ISSNHL with tinnitus. By generating preliminary evidence on its practicality and potential benefits, this study aims to inform the design and sample size estimation of future multicenter trials, potentially advancing nonpharmacological treatment options for this challenging condition.
Trial RegistrationChinese Clinical Trial Registry ChiCTR2400086802; https://tinyurl.com/mtxthpzj
International Registered Report Identifier (IRRID)DERR1-10.2196/69163 |
| format | Article |
| id | doaj-art-84287f32eef24dbeafc7fd57a085fa5c |
| institution | OA Journals |
| issn | 1929-0748 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | JMIR Publications |
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| spelling | doaj-art-84287f32eef24dbeafc7fd57a085fa5c2025-08-20T01:49:55ZengJMIR PublicationsJMIR Research Protocols1929-07482025-05-0114e6916310.2196/69163Combination of Electroacupuncture and Medication for Patients With Tinnitus Associated With Idiopathic Sudden Sensorineural Hearing Loss: Protocol for a Prospective Randomized Controlled TrialTuoran Wanghttps://orcid.org/0009-0000-5209-4027Lingyu Qihttps://orcid.org/0000-0002-7167-776XXinping Haohttps://orcid.org/0000-0001-8835-2948Miao Zhanghttps://orcid.org/0009-0004-2981-6676Shihao Duhttps://orcid.org/0000-0002-1207-6542Biao Chenhttps://orcid.org/0000-0002-2436-4621Chang Liuhttps://orcid.org/0000-0002-4031-4392Jing Chenhttps://orcid.org/0000-0002-4938-7299Xinyue Zouhttps://orcid.org/0009-0003-0452-0695Ping Liuhttps://orcid.org/0009-0008-0697-0637Jin Huohttps://orcid.org/0000-0002-1327-0101 BackgroundTinnitus, a common and troublesome symptom of idiopathic sudden sensorineural hearing loss (ISSNHL), is the perception of sound without any external or internal sound source. The etiology of ISSNHL accompanied by tinnitus remains unclear. Tinnitus often occurs alongside or before hearing loss and can severely impact patients’ quality of life, leading to psychological stress and emotional distress. Current treatments primarily focus on improving hearing loss while neglecting tinnitus treatment. Electroacupuncture (EA), a technique widely applied in China for tinnitus management, may become a promising intervention by addressing both auditory and psychological symptoms. ObjectiveThis study aims to conduct a double-center, assessor-blinded, prospective randomized pilot clinical trial to explore the potential effects and feasibility of EA combined with medication for patients with ISSNHL accompanied by tinnitus, and to generate preliminary data to inform future large-scale trials of EA as an adjunctive therapy for this condition. MethodsIn this double-center, assessor-blinded, randomized controlled trial, 60 patients with ISSNHL accompanied by tinnitus will be randomly allocated to either the EA group, receiving EA combined with medication, or the control group, receiving standard medication treatment, for a total treatment duration of 4 weeks. Follow-up assessments will be conducted at weeks 2 and 4, and at 1, 2, and 3 months after treatment. The feasibility primary outcomes are recruitment rate, adherence rate, data completeness, and safety outcomes. The primary outcome measures will include pure tone audiometry, tinnitus matching, and the Tinnitus Handicap Inventory, while the secondary outcome measures will comprise speech-recognition thresholds in noise, the Self-Rating Anxiety Scale, and the 36-item Short Form Health Survey Questionnaire. ResultsThis study began recruitment on July 15, 2024, and is scheduled to conclude on August 31, 2025. To date, 42 participants have been enrolled, with 35 having completed the intervention and posttreatment assessments (control group: n=21; EA group: n=14). Following protocol publication, data compilation and analysis will be conducted, with results anticipated to be published in a relevant journal in 2026. ConclusionsThis pilot trial is expected to provide critical insights into the feasibility of integrating EA with standard medication for managing ISSNHL with tinnitus. By generating preliminary evidence on its practicality and potential benefits, this study aims to inform the design and sample size estimation of future multicenter trials, potentially advancing nonpharmacological treatment options for this challenging condition. Trial RegistrationChinese Clinical Trial Registry ChiCTR2400086802; https://tinyurl.com/mtxthpzj International Registered Report Identifier (IRRID)DERR1-10.2196/69163https://www.researchprotocols.org/2025/1/e69163 |
| spellingShingle | Tuoran Wang Lingyu Qi Xinping Hao Miao Zhang Shihao Du Biao Chen Chang Liu Jing Chen Xinyue Zou Ping Liu Jin Huo Combination of Electroacupuncture and Medication for Patients With Tinnitus Associated With Idiopathic Sudden Sensorineural Hearing Loss: Protocol for a Prospective Randomized Controlled Trial JMIR Research Protocols |
| title | Combination of Electroacupuncture and Medication for Patients With Tinnitus Associated With Idiopathic Sudden Sensorineural Hearing Loss: Protocol for a Prospective Randomized Controlled Trial |
| title_full | Combination of Electroacupuncture and Medication for Patients With Tinnitus Associated With Idiopathic Sudden Sensorineural Hearing Loss: Protocol for a Prospective Randomized Controlled Trial |
| title_fullStr | Combination of Electroacupuncture and Medication for Patients With Tinnitus Associated With Idiopathic Sudden Sensorineural Hearing Loss: Protocol for a Prospective Randomized Controlled Trial |
| title_full_unstemmed | Combination of Electroacupuncture and Medication for Patients With Tinnitus Associated With Idiopathic Sudden Sensorineural Hearing Loss: Protocol for a Prospective Randomized Controlled Trial |
| title_short | Combination of Electroacupuncture and Medication for Patients With Tinnitus Associated With Idiopathic Sudden Sensorineural Hearing Loss: Protocol for a Prospective Randomized Controlled Trial |
| title_sort | combination of electroacupuncture and medication for patients with tinnitus associated with idiopathic sudden sensorineural hearing loss protocol for a prospective randomized controlled trial |
| url | https://www.researchprotocols.org/2025/1/e69163 |
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