Effects of Music Combined With Cognitive Behavioral Therapy on Chronic Subjective Tinnitus and a Multi-Factor Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- tinnitus loudness
研究概览
简要总结
This study retrospectively analyzed the first and second visit data of chronic subjective tinnitus patients who received music combined with cognitive behavioral therapy in our hospital in recent years. Behavioral tests and tinnitus questionnaires, as well as sleep and depression scores, were used to analyze the therapeutic effects of this approach. EEG results were analyzed as a potential neurobiological marker to explore the neural mechanism of tinnitus symptom improvement.
详细描述
The subjects of this study were chronic subjective tinnitus patients and normal controls who were treated with music therapy combined with cognitive behavioral therapy (music-CBT) in the Department of Otolaryngology of Sun Yat-sen Memorial Hospital from December 2016 to March 2024 and who had completed re-examination. The pre- and post-music-CBT data of past patients who met our study conditions were collected for retrospective statistics. The complete sample data included medical history, pure tone audiometry, tinnitus matching, tinnitus questionnaires (Tinnitus Handicap Inventory, Visual Analog Scales, tinnitus Functional Index), sleep quality questionnaire (Pittsburgh Sleep Quality Index), and depression questionnaire (Hamilton Depression Scale -24 items). The resting state electroencephalogram (rs-EEG). Retrospective statistical analysis was conducted to determine the clinical efficacy and influencing factors of music-CBT for chronic subjective tinnitus at 3 months and long term. Finally, the neural mechanism of music-CBT for tinnitus treatment was analyzed based on rs-EEG results.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults aged between 18 and 60
- •a total score of 18 or higher on THI
- •a constant tinnitus that can be matched
- •right-handed
- •no significant medical or psychiatric conditions
排除标准
- •intermittent, pulsating or objective tinnitus
- •central nervous system disease
- •cognitive impairment
- •other contraindications for EEG testing
结局指标
主要结局
tinnitus loudness
时间窗: the exact 1 day of the first visit and review visit, within 3 - 4.5 months
Tinnitus loudness was calculated by the matched intensity subtracting the pure tone threshold at that frequency.
tinnitus handicap inventory (THI)
时间窗: the exact 1 day of the first visit and review visit, within 3 - 4.5 months
There were 25 items in the THI scale, divided into three subscales (functional, emotional, and catastrophic), and response choices consisted of "no" (0 points), "sometimes" (2 points), and "yes" (4 points). A higher score of THI indicateed more severe tinnitus.
pure tone audiometry
时间窗: the exact 1 day of the first visit
The air conductivity threshold of pure tone audiometry across the frequency range of 500-4000Hz is referred to as the pure tone average (PTA) for the tested ear
EEG functional connectivity and brain network characteristics
时间窗: the exact 1 day of the first visit and review visit, within 3 - 4.5 months
EEG signals were used to explore the activation of brain regions and remodeling of poor connections in the postoperative outcomes of conductive hearing loss patients accompanied by with tinnitus. Power spectral density calculation, traceability analysis, functional connection, microstate, clustering coefficient, feature path length, feature path intermediation, and isocompatibility coefficient were collected and then analyzed.
tinnitus functional index (TFI)
时间窗: the exact day of the first visit and review visit, within 3 - 4.5 months
The TFI scale assessed tinnitus-related distress and severity. It contained 8 subscales. They were denoted as TFI-I (Intrusiveness) and TFI-SC (Sense of) control), TFI-C (Cognition), TFI-S (Sleep), TFI-A (Auditory), TFI-R (Relaxation), TFI-Q (Quality of life), TFI-E (Emotional) distress); A total of 25 items are included. Each item worthes 100 points. The average score of all items was recorded as the total TFI score (0-100). A higher score of TFI indicateed more severe tinnitus.
次要结局
- Hamilton Depression Scale -24 items (HAMD-24)(the exact 1 day of the first visit and review visit, within 3 - 4.5 months)
- Pittsburgh sleep quality index (PSQI)(the exact 1 day of the first visit and review visit, within 3 - 4.5 months)
- visual analogue scale (VAS)(the exact 1 day of the first visit and review visit, within 3 - 4.5 months)