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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
68
Listening to unmodified music for at least 2 hours a day
Listening to modified tinnitus relieving sound for at least 2 hours a day
Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
Shanghai, Shanghai Municipality, China
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 9 months from baseline
tinnitus loudness matched by sensation level (LM, SL)
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months from baseline