The Brain Network Mechanism and Outcome After Surgical Intervention of Conductive Hearing Loss Accompanied by Tinnitus.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- speech test
研究概览
简要总结
This study explores the brain region activation and remodeling of poor connections of brain regions in the postoperative outcomes of conductive hearing loss patients with tinnitus by comparing pre - and post-operative audiological assessment, tinnitus assessment and EEG data.
详细描述
This study explores the brain region activation and remodeling of poor connections of brain regions in the postoperative outcomes of conductive hearing loss patients with tinnitus by comparing pre - and post-operative audiological assessment, tinnitus assessment and EEG data. Including audiological assessment (pure tone audiometry, speech test), tinnitus assessment (tinnitus matching, tinnitus handicap inventory, tinnitus function index, visual analogue scale)and non-invasive brain imaging assessment (EEG, fNIRS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 18 and 60 years;
- •diagnosed with conductive hearing loss with tinnitus;
- •treated with surgery;
- •able to cooperate with all Chinese version evaluation;
- •right-handed.
排除标准
- •Pure tone audiometry indicates that the average pure tone hearing threshold (500Hz, 1kHz, 2kHz, 4kHz) is > 91dB HL;
- •acoustic neuroma, nasopharyngeal carcinoma;
- •hearing loss caused by noise or drugs.
结局指标
主要结局
speech test
时间窗: 3-7 days before surgery, 1-12 months after surgery
Speech audiometry was mainly used to analyze the speech recognition rate of patients before and after surgery
pure tone audiometry
时间窗: 3-7 days before surgery, 1-12 months after surgery
The air- conducted threshold, bone-conducted threshold and air- bone gap of each frequency of pure tone audiometry were used to compare pre - and post-operative hearing level.
EEG activation
时间窗: 3-7 days before surgery, 1-12 months after surgery
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 handicap inventory scores
时间窗: 3-7 days before surgery, 1-12 months after surgery
The total score of the THI scale and the scores of the three subscales(functional, emotional, and catastrophic) were collected before and after surgery for data analysis.
次要结局
- fNIRS activation(3-7 days before surgery, 1-12 months after surgery)
- tinnitus function index scores(3-7 days before surgery, 1-12 months after surgery)
- visual analogue scale(3-7 days before surgery, 1-12 months after surgery)