Evaluation of the Central Auditory Processing in Patients (Elder Than 45 Years Old) With Bilateral Sensorineural Hearing Loss and the Change of the Central Auditory Processing Ability by the Use of Hearing Aids (CAPHA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change from the baseline in the Hearing In Noise Test (HINT) score at 6 months
研究概览
简要总结
The purpose of this study is to evaluate the central auditory processing in patients with bilateral sensorineural hearing loss and to observe the change of the central auditory processing ability after using hearing aids.
详细描述
Screening for recruiting
- Among patients who are visiting for hearing disturbance, patients with bilateral sensorineural hearing loss will be included after audiologic tests, history taking and physical examination.
- audiologic tests: pure tone audiometry, speech audiometry, impedence audiometry, distortion product otoacoustic emission, auditory brainstem response.
Dividing into "Hearing aids" group and "No hearing aids" group
- The use of hearing aids will be recommended to all included patients.
- Hearing aids group: patients who want to be prescribed hearing aids (28 subjects)
- No hearing aids group: patients who do not want to be prescribed hearing aids (28 subjects)
Audiologic test
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults of age 45 years of older
- •Bilateral sensorineural hearing loss
- •Average pure tone audiometry threshold >= 40dB
- •Speech discrimination >= 60% in both ears
排除标准
- •Refusing the study
- •Medical history of any brain damage or intracranial surgery
- •Showing signs of central lesion in MRI or neurologic exams
- •Speech discrimination < 60% in any ear
研究组 & 干预措施
Hearing aids
Patients who agree to use hearing aids
干预措施: Hearing aids (Device)
No hearing aids
Patients who did not agree to use hearing aids
结局指标
主要结局
Change from the baseline in the Hearing In Noise Test (HINT) score at 6 months
时间窗: at screening and 6 months after starting hearing aids use
HINT measures a person's ability to hear speech in quiet and in noise. In the test, the patient is required to repeat sentences both in a quiet environment and with competing noise being presented from different directions.
次要结局
- changes from the baseline in central auditory processing disorder test score at 1, 3, 6, 9 and 12 months(at screening, 1, 3, 6, 9, and 12 months after starting hearing aids use)
- changes from the baseline in the HINT score at 3, 9, and 12 months(baseline, 3, 9 and 12 months)
研究者
Jong Woo Chung
MD
Asan Medical Center