【ChiCTR1800018533】建立寬頻聲阻抗於中國人耳朵的標準數據

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基本信息

登记号

ChiCTR1800018533

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2018-09-05

临床申请受理号

靶点

适应症

Middle-ear disorder

试验通俗题目

建立寬頻聲阻抗於中國人耳朵的標準數據

试验专业题目

建立寬頻聲阻抗於中國人耳朵的標準數據

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

联系人通讯地址

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临床试验信息

试验目的

To establish Chinese normative data of wideband Energy Absorbance, which, is an emerging objective audiological measurement for revealing aural acoustic transfer function over a board frequency range.

试验分类

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试验类型

横断面

试验分期

Ⅰ期

随机化

N/A

盲法

N/A

试验项目经费来源

Dept. of Otorhinolaryngology, Head and Neck Surgery, CUHK

试验范围

目标入组人数

360

实际入组人数

第一例入组时间

1990-01-01

试验终止时间

1990-01-01

是否属于一致性

入选标准

For normative data, we plan to recruit thirty participants in 1:1 gender ratio in each of the following age groups: 3 – 5;11 years, 6 – 9;11 years, 10 – 30 years, 31 – 45 years, 46 – 60 years, 61 – 75 years, 76 years old and above; corresponding to a minimum of 210 participants. The inclusion criteria are: 1. Outpatients of the Dept. of Ear, Nose and Throat of the Prince of Wales Hospital (PWH, NTEC) who are aged 3 years and above and referred to the PWH Audiology Centre for audiological assessments; 2. Negative history of chronic middle-ear disease; 3. 226 Hz tympanometric criteria within normal limits, defined as having middle-ear compliance ≥ 0.3 ml, middle-ear pressure within +/- 100 daPa, and equivalent ear-canal volume ≤ 2.0 cm3; 4. Absence of significant air-bone gaps in the ear to be assessed, defined as having air-bone gap of no greater than 10 dB at 0.5, 1, 2, & 4 kHz; 5. No gross eardrum abnormalities or excessive cerumen as revealed via otoscopic examination, in the ear to be assessed; 6. Able to understand the consenting procedure and willing to provide written consent; for children aged under 18 years written consent will be obtained from accompanying parent or guardian. For disease-specific data, we plan to recruit 150 adult patients meeting the following criteria: 1. Outpatients of the PWH Dept. of Ear, Nose and Throat who are aged 18 years and above and referred to the PWH Audiology Centre for audiological assessments; 2. Referral reason is middle-ear related, e.g. conductive hearing loss, otosclerosis, otitis media effusion (OME), tympanic membrane perforation, middle-ear disease; 3. Referred for standard tympanometry as well; 4. Absence of any of the exclusion criteria abovementioned for normative sample.；

排除标准

Adult or child who presents any of the followings will be excluded: active discharge in ear canal, swollen ear canal, atresia, failure to comply with test procedures including insertion of test probe.；

研究者信息

研究负责人姓名

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试验机构

香港中文大學頭頸外科耳鼻咽喉科

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