今天是:2020-08-03 星期一

正常成年人及儿童声变复合波与声源定位的初步研究
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注册号:

Registration number:

ChiCTR2000034506 

最近更新日期:

Date of Last Refreshed on:

2020-07-08 

注册时间:

Date of Registration:

2020-07-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

正常成年人及儿童声变复合波与声源定位的初步研究 

Public title:

A preliminary study on Acoustic Change Complex and Sound Localization in normal adult and child 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

正常人及耳聋患者辅听设备干预后声源定位能力及言语能力研究 

Scientific title:

A study on the ability of sound source localization and speech ability of normal people and deaf patients after the intervention of auxiliary hearing equipment 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

樊知桐 

研究负责人:

张娟 

Applicant:

Fan Zhitong 

Study leader:

Zhang Juan 

申请注册联系人电话:

Applicant telephone:

+86 15810066460 

研究负责人电话:

Study leader's telephone:

+86 15810636610 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

308718834@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

chinayudian@sina.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

北京市朝阳区工体南路8号 

研究负责人通讯地址:

北京市朝阳区工体南路8号 

Applicant address:

8 Workers' Stadium Road South, Chaoyang District, Beijing 

Study leader's address:

8 Workers' Stadium Road South, Chaoyang District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

首都医科大学附属北京朝阳医院 

Applicant's institution:

Beijing Chao-Yang Hospital, Capital Medical University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2019-科-349 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

首都医科大学附属北京朝阳医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Beijing Chao-Yang Hospital, Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-12-02 

伦理委员会联系人:

吕老师 

Contact Name of the ethic committee:

Miss Lyu 

伦理委员会联系地址:

北京市朝阳区工体南路8号 

Contact Address of the ethic committee:

8 Workers' Stadium Road South, Chaoyang District, Beijing 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

首都医科大学附属北京朝阳医院 

Primary sponsor:

Beijing Chao-Yang Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京市朝阳区工体南路8号 

Primary sponsor's address:

8 Workers' Stadium Road South, Chaoyang District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京朝阳医院

具体地址:

朝阳区工体南路8号

Institution
hospital:

Beijing Chao-Yang Hospital, Capital Medical University

Address:

8 Workers' Stadium Road South, Chaoyang District

经费或物资来源:

中国国家自然科学基金 

Source(s) of funding:

National Natural Science Foundation of China 

研究疾病:

听力障碍/声源定位 

Target disease:

Hearing Loss/ Sound Localization 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

本试验采用电生理方法研究正常成年人及儿童的声源定位能力,探索客观的声源定位检查方法。 

Objectives of Study:

In this study, electrophysiological methods were used to study the sound localization ability of normal adults and children, and to explore an objective method of sound source localization. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

1.听力正常成年人,正规听力学检测双耳PTA≤25dB; 2.听力正常儿童,正规听力学检测双耳PTA≤15dB HL; 3.外耳道及鼓膜正常; 4.能够配合实验。 

Inclusion criteria

1. Normal hearing adults, PTA <= 25dB; 2. Normal hearing children, PTA <= 15dB HL; 3. Normal external auditory canal and tympanic membrane; 4. Be able to cooperate with the experiment. 

排除标准:

1.有活动性耳科疾病; 2.有严重颈椎疾病,不能正常转头; 3.存在认知功能障碍受试者。 

Exclusion criteria:

1. Active ear diseases; 2. Serious cervical spondylopathy, unable to turn head normally; 3. Subjects with cognitive impairment. 

研究实施时间:

Study execute time:

From2020-08-01To 2023-07-31 

征募观察对象时间:

Recruiting time:

From2020-08-01To 2023-07-31 

干预措施:

Interventions:

组别:

正常青年人及儿童

样本量:

97

Group:

Normal Young People

Sample size:

干预措施:

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京朝阳医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Chao-Yang Hospital, Capital Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

声变复合波

指标类型:

主要指标 

Outcome:

Acoustic Change Complex

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

角度辨别阈值

指标类型:

主要指标 

Outcome:

Minimum Audible Angle

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

角度偏差数值

指标类型:

主要指标 

Outcome:

Root Mean Square

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 1 years
最大 Max age 65 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

不适用

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

试验完成后6个月时,在本网站详细描述试验结果,粘贴发表文章。若需要提供原始数据,可通过邮箱来信要求。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

6 months after the completion of the trial, the results will be described in detail on the site, and the articles be posted. If you need to provide the original data, please email the investigator.

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

基本资料采用病历记录表储存,脑电图资料采用数据格式存储。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

The basic data were stored in the medical record form, and the EEG data were stored in the data format.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-07-07
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