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【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

申请人名称

联系人邮箱

联系人邮编

联系人通讯地址

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

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

试验机构

香港中文大學頭頸外科耳鼻咽喉科

研究负责人电话

研究负责人邮箱

研究负责人邮编

联系人通讯地址

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