ChiCTR1800019012尚未招募不适用
黏合式骨導助聽器對傳導性弱聽人士的聽力效益及用者滿意狀況
Dept. of Otorhinolaryngology, Head and Neck Surgery, CUHK1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 1990年1月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in sound-field audiometric threshold
研究概览
简要总结
黏合式骨導助聽器對傳導性弱聽人士的聽力效益及用者滿意狀況
研究设计
- 研究类型
- 观察性研究
- 主要目的
- 单臂
- 盲法
- N/a
入排标准
- 年龄范围
- 6 至 —（—）
- 性别
- All
入选标准
- •Unilateral or bilateral conductive hearing loss, as defined by the affected ear(s) having bone-conduction thresholds of no worse than 25 dB(HL) at 0.5 – 4 kHz and air-bone gaps of at least 10 dB at three of the tested frequencies;
- •Absence of skin or scalp conditions that may preclude attachment of the adhesive adapter, or interfere with audio processor usage;
- •Aged 6 years and above and can comply with evaluation procedures;
- •Cantonese as the primary language;
- •Willingness to attend extra audiological sessions for evaluating device benefits;
- •Willingness to fill out journal regarding device usage and questionnaires regarding user satisfaction;
- •Willingness and being able to provide daily care to a loaned device;
- •Gives consent to taking part in the study.
排除标准
- •Does not meet one or more of the inclusion criteria listed above;
- •Any type of hearing loss other than conductive;
- •Health, physical, or cognitive conditions that would interfere with the completion of, participation in, or provision of valid responses during the required audiological evaluations, or interfere with adherence to study procedures.
研究组 & 干预措施
Case series
An adhesive form of bone-conduction hearing device, 8 weeks of use during waking hours
结局指标
主要结局
Change in sound-field audiometric threshold
时间窗: Week 4, Week 8
Change in sentence reception threshold in noise
时间窗: Week 4, Week 8
Self-rated hearing qualities associated with device use
时间窗: Week 4, Week 8
次要结局
- User experience with the adhesive bone-conduction device(Week 8)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
罗琼老师：该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者，并与我们联系上传批件。 SOUNDBIT 牙骨传导助听器在传导性聋的临床试验方案研究传导性听力损失ChiCTR1900022756试验所需的牙传导助听器由声佗医疗科技（上海）有限公司提供20
尚未招募
Unknown
谢友舟医师：请上传正式伦理审批文件。 模块化骨导助听设备的设计传导性聋ChiCTR2000033500复旦大学附属眼耳鼻喉科医院40
Unknown
不适用
助听器对听障老年人抑郁状况的干预研究ChiCTR2300069838国家或省自然科学基金
Unknown
不适用
听神经瘤术后单侧耳聋听觉功能重建的临床研究ChiCTR-OOC-17012339自筹34
Unknown
不适用
人工耳蜗患者皮层听觉诱发电位研究ChiCTR2200058334国家或者省自然基金100