Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
68 participants
INTERVENTIONAL
2019-08-31
2022-02-28
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Unmodified music group
34 participants in Group 1 will listen to the music without any modification for at least two hours a day in total.
Listening to unmodified music
Listening to unmodified music for at least 2 hours a day
Modified tinnitus relieving sound group
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.
Listening to modified tinnitus relieving sound
Listening to modified tinnitus relieving sound for at least 2 hours a day
Interventions
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Listening to unmodified music
Listening to unmodified music for at least 2 hours a day
Listening to modified tinnitus relieving sound
Listening to modified tinnitus relieving sound for at least 2 hours a day
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with subjective tinnitus;
3. Chronic tinnitus: tinnitus course ≥3 months;
4. Be able to understand and communicate with Mandarin；
5. The average pure tone threshold (0.5, 1, 2kHz) ≤ 55dB HL of the worse ear;
6. 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
2. Having significant health issues that affect or prevent participation or continue with the follow-up;
3. Diseases requiring other medical intervention first (eg, infections, tumors, otosclerosis, Meniere's disease, the acute stage of sudden sensorineural hearing loss);
4. People with severe hyperacusis, severe anxiety, depression and other psychiatric disorders；
5. Currently participating in other research projects that may affect tinnitus；
6. Subjects who are not considered suitable for this clinical trial by the researchers.
18 Years
80 Years
ALL
No
Sponsors
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Eye & ENT Hospital of Fudan University
OTHER
Responsible Party
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Principal Investigators
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Huawei Li
Role: STUDY_CHAIR
Eye and ENT Hospital of Fudan University
Locations
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Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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Tinnitus sound therapy RCT
Identifier Type: -
Identifier Source: org_study_id
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