The Clinical Effects of Modified Tinnitus Relieving Sound Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Tinnitus Handicapped Inventory (THI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Listening to unmodified music (Other)
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.
干预措施: Listening to modified tinnitus relieving sound (Other)
结局指标
主要结局
Tinnitus Handicapped Inventory (THI)
时间窗: 12 months from baseline
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.
Hospital Anxiety and Distress Scale (HADS)
时间窗: 12 months from baseline
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).
Visual Analogue Scale (VAS) for tinnitus
时间窗: 12 months from baseline
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.
Tinnitus Handicapped Inventory (THI)
时间窗: 1 months from baseline
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.
Tinnitus Handicapped Inventory (THI)
时间窗: 3 months from baseline
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.
Tinnitus Handicapped Inventory (THI)
时间窗: 9 months from baseline
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.
Visual Analogue Scale (VAS) for tinnitus
时间窗: 1 months from baseline
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.
Hospital Anxiety and Distress Scale (HADS)
时间窗: 1 months from baseline
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).
Hospital Anxiety and Distress Scale (HADS)
时间窗: 3 months from baseline
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).
Hospital Anxiety and Distress Scale (HADS)
时间窗: 9 months from baseline
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).
Visual Analogue Scale (VAS) for tinnitus
时间窗: 3 months from baseline
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.
Visual Analogue Scale (VAS) for tinnitus
时间窗: 9 months from baseline
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.
次要结局
- Athens Insomnia Scale (AIS)(12 months from baseline)
- tinnitus loudness matched by sensation level (LM, SL)(12 months from baseline)
- minimum masking level (MML)(12 months from baseline)
- Athens Insomnia Scale (AIS)(1 months from baseline)
- Athens Insomnia Scale (AIS)(3 months from baseline)
- Athens Insomnia Scale (AIS)(9 months from baseline)
- tinnitus loudness matched by sensation level (LM, SL)(1 months from baseline)
- tinnitus loudness matched by sensation level (LM, SL)(3 months from baseline)
- tinnitus loudness matched by sensation level (LM, SL)(9 months from baseline)
- minimum masking level (MML)(1 months from baseline)
- minimum masking level (MML)(3 months from baseline)
- minimum masking level (MML)(9 months from baseline)