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Benefits and efficacy of cochlear implant system in subjects with unilateral or asymmetrical acquired sensorineural severe-to-profound hearing loss
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注册号：

Registration number：

 ChiCTR1900021885 

最近更新日期：

Date of Last Refreshed on：

 2019-03-15 00:20:05 

注册时间：

Date of Registration：

 2019-03-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Benefits and efficacy of cochlear implant system in subjects with unilateral or asymmetrical acquired sensorineural severe-to-profound hearing loss

Public title：

Benefits and efficacy of cochlear implant system in subjects with unilateral or asymmetrical acquired sensorineural severe-to-profound hearing loss

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Benefits and efficacy of cochlear implant system in subjects with unilateral or asymmetrical acquired sensorineural severe-to-profound hearing loss

Scientific title：

Benefits and efficacy of cochlear implant system in subjects with unilateral or asymmetrical acquired sensorineural severe-to-profound hearing loss

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：

Yeung Kammy Ngan-kam 

研究负责人：

Tong Michael Chi-fai 

Applicant：

Yeung Kammy Ngan-kam 

Study leader：

Tong Michael Chi-fai 

申请注册联系人电话：

Applicant telephone：

 +852 35052628

研究负责人电话：

Study leader's
telephone：

+852 35052628

申请注册联系人传真 ：

Applicant Fax：

 +852 3942 0969

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：

 kammyyeung@ent.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 mtong@ent.cuhk.edu.hk

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：

Room 303, Academic Building No.2, Chinese University of Hong Kong, China

研究负责人通讯地址：

中國香港特別行政區新界沙田威爾斯親王醫院呂志和臨床科學大樓6樓

Applicant address：

Room 303, Academic Building No.2, Chinese University of Hong Kong, China

Study leader's address：

Room 84026, 6/F, Lui Che Woo Clinical Sciences Building, The Chinese University of Hong Kong, Prince of Wales Hospital

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：

香港中文大學

Applicant's institution：

Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

Chinese University of Hong Kong

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：

 2017.537-T

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

Joint CUHK-NTEC CREC

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-02-07 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

中國香港特別行政區新界沙田威爾斯親王醫院呂志和臨床科學大樓8樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3824

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 crec2@cuhk.edu.hk

研究实施负责（组长）单位：

香港中文大學

Primary sponsor：

Chinese University of Hong Kong

研究实施负责（组长）单位地址：

香港中文大學

Primary sponsor's address：

Chinese University of Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

N/A

Source(s) of funding：

N/A

研究疾病：

acquired unilateral or asymmetrical severe-to-profound hearing loss  

Target disease：

acquired unilateral or asymmetrical severe-to-profound hearing loss

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

单臂 

Study design：

Single arm 

研究目的：

To evaluate the benefit and efficacy of cochlear implantation in patients with acquired unilateral or asymmetrical severe-to-profound hearing loss.  

Objectives of Study：

To evaluate the benefit and efficacy of cochlear implantation in patients with acquired unilateral or asymmetrical severe-to-profound hearing loss.

药物成份或治疗方案详述：

1. To demonstrate that word and sentence understanding in quiet and in noise after 6 months of implant use are significantly better than pre-implant scores with conventional amplification in the implanted ear; 2. To demonstrate a decrease of tinnitus for the sub population suffering a very severe tinnitus at baseline. 

Description for medicine or protocol of treatment in detail：

1. To demonstrate that word and sentence understanding in quiet and in noise after 6 months of implant use are significantly better than pre-implant scores with conventional amplification in the implanted ear; 2. To demonstrate a decrease of tinnitus for the sub population suffering a very severe tinnitus at baseline. 

纳入标准：

Inclusion criteria

排除标准：

1. Unilateral deafness resulting from non-intact auditory nerve;
2. Cochlear malformation or obstruction that would preclude full insertion of electrode array;
3. Presence of additional disabilities that would prevent or interfere with participation in the required study procedures;
4. Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures;
5. Indication for central auditory lesion or compromised auditory nerve.

Exclusion criteria：

1. Unilateral deafness resulting from non-intact auditory nerve;
2. Cochlear malformation or obstruction that would preclude full insertion of electrode array;
3. Presence of additional disabilities that would prevent or interfere with participation in the required study procedures;
4. Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures;
5. Indication for central auditory lesion or compromised auditory nerve.

研究实施时间：

Study execute time：

从 From 2019-04-01 00:00:00至 To 2021-04-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-04-01 00:00:00 至 To 2019-09-30 00:00:00

干预措施：

Interventions：

组别：

Hearing loss

样本量：

 10

Group：

Hearing loss

Sample size：

干预措施：

Cochlear Implant

干预措施代码：

Intervention：

Cochlear Implant

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 香港中文大學 

单位级别：

 香港中文大學 

Institution
hospital：

Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Word (Disyllabic) and sentence (CHINT sentences) at 65 dB SPL in soundfield

指标类型：

主要指标

Outcome：

Word (Disyllabic) and sentence (CHINT sentences) at 65 dB SPL in soundfield

Type：

Primary indicator

测量时间点：

Post 1,3, 6, 12, 18, and 24 months

测量方法：

Word (monosyllabic) and sentence (CHINT sentences) at 65 dB SPL in soundfield

Measure time point of outcome：

Post 1,3, 6, 12, 18, and 24 months

Measure method：

Word (monosyllabic) and sentence (CHINT sentences) at 65 dB SPL in soundfield

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

NA

Tissue：

NA

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

NA

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 6 岁 years
最大 Max age 70 岁 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）：

N/A

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

N/A

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

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)：

是否共享原始数据：

IPD sharing

否No

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）：

Not stated

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

Not stated

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：

Database

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

Database

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2019-03-15 00:20:05
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