Today is 2019-12-07

Audiological benefits and subjective satisfaction with adhesive bone-conduction device in conductive hearing loss patients
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注册号:

Registration number:

ChiCTR1800019012 

最近更新日期:

Date of Last Refreshed on:

2018-10-21 

注册时间:

Date of Registration:

2018-10-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

黏合式骨導助聽器對傳導性弱聽人士的聽力效益及用者滿意狀況 

Public title:

Audiological benefits and subjective satisfaction with adhesive bone-conduction device in conductive hearing loss patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

黏合式骨導助聽器對傳導性弱聽人士的聽力效益及用者滿意狀況 

Scientific title:

Audiological benefits and subjective satisfaction with adhesive bone-conduction device in conductive hearing loss patients 

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:

CUHK_CCRB00626 

申请注册联系人:

Ms. Kit Chan 

研究负责人:

Michael Tong 

Applicant:

Ms. Kit Chan 

Study leader:

Michael Tong 

申请注册联系人电话:

Applicant telephone:

+852 3505 1277 

研究负责人电话:

Study leader's telephone:

+852 3505 1277 

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:

kitchan@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):

https://www2.ccrb.cuhk.edu.hk/registry/public/607 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

https://www2.ccrb.cuhk.edu.hk/registry/public/607 

申请注册联系人通讯地址:

Room 84026, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong SAR, China 

研究负责人通讯地址:

Room 84026, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong SAR, China 

Applicant address:

Room 84026, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong SAR, China 

Study leader's address:

Room 84026, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong SAR, China 

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:

Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong 

Applicant's institution:

Department of Otorhinolaryngology, Head and Neck Surgery, The 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:

2017.553 

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:

Joint CUHK-NTEC Clinical Research Ethics Committee 

Name of the ethic committee:

Joint CUHK-NTEC Clinical Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-01-24 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

The Chinese University of Hong Kong 

Primary sponsor:

The Chinese University of Hong Kong 

研究实施负责(组长)单位地址:

The Chinese University of Hong Kong 

Primary sponsor's address:

The 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:

Dept. of Otorhinolaryngology, Head and Neck Surgery, CUHK 

Source(s) of funding:

Dept. of Otorhinolaryngology, Head and Neck Surgery, CUHK 

研究疾病:

傳導性弱聽 

Target disease:

conductive 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:

其它 

Study phase:

N/A 

研究目的:

黏合式骨導助聽器對傳導性弱聽人士的聽力效益及用者滿意狀況 

Objectives of Study:

Audiological benefits and subjective satisfaction with adhesive bone-conduction device in conductive hearing loss patients 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1. Unilateral or bilateral conductive hearing loss, as defined by the affected ear(s) having bone-conduction thresholds of no worse than 25 dB(HL) at 0.5 – 4 kHz and air-bone gaps of at least 10 dB at three of the tested frequencies; 2. Absence of skin or scalp conditions that may preclude attachment of the adhesive adapter, or interfere with audio processor usage; 3. Aged 6 years and above and can comply with evaluation procedures; 4. Cantonese as the primary language; 5. Willingness to attend extra audiological sessions for evaluating device benefits; 6. Willingness to fill out journal regarding device usage and questionnaires regarding user satisfaction; 7. Willingness and being able to provide daily care to a loaned device; 8. Gives consent to taking part in the study. 

Inclusion criteria

1. Unilateral or bilateral conductive hearing loss, as defined by the affected ear(s) having bone-conduction thresholds of no worse than 25 dB(HL) at 0.5 – 4 kHz and air-bone gaps of at least 10 dB at three of the tested frequencies; 2. Absence of skin or scalp conditions that may preclude attachment of the adhesive adapter, or interfere with audio processor usage; 3. Aged 6 years and above and can comply with evaluation procedures; 4. Cantonese as the primary language; 5. Willingness to attend extra audiological sessions for evaluating device benefits; 6. Willingness to fill out journal regarding device usage and questionnaires regarding user satisfaction; 7. Willingness and being able to provide daily care to a loaned device; 8. Gives consent to taking part in the study. 

排除标准:

1. Does not meet one or more of the inclusion criteria listed above; 2. Any type of hearing loss other than conductive; 3. Health, physical, or cognitive conditions that would interfere with the completion of, participation in, or provision of valid responses during the required audiological evaluations, or interfere with adherence to study procedures. 

Exclusion criteria:

1. Does not meet one or more of the inclusion criteria listed above; 2. Any type of hearing loss other than conductive; 3. Health, physical, or cognitive conditions that would interfere with the completion of, participation in, or provision of valid responses during the required audiological evaluations, or interfere with adherence to study procedures. 

研究实施时间:

Study execute time:

FromTo  

干预措施:

Interventions:

组别:

Case series

样本量:

40

Group:

Case series

Sample size:

干预措施:

An adhesive form of bone-conduction hearing device, 8 weeks of use during waking hours

干预措施代码:

Intervention:

An adhesive form of bone-conduction hearing device, 8 weeks of use during waking hours

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):

The Chinese University of Hong Kong 

单位级别:

The Chinese University of Hong Kong 

Institution
hospital:

The Chinese University of Hong Kong  

Level of the institution:

The Chinese University of Hong Kong 

测量指标:

Outcomes:

指标中文名:

Change in sound-field audiometric threshold

指标类型:

主要指标 

Outcome:

Change in sound-field audiometric threshold

Type:

Primary indicator 

测量时间点:

Week 4, Week 8

测量方法:

Sound-field audiometry

Measure time point of outcome:

Week 4, Week 8

Measure method:

Sound-field audiometry

指标中文名:

Change in sentence reception threshold in noise

指标类型:

主要指标 

Outcome:

Change in sentence reception threshold in noise

Type:

Primary indicator 

测量时间点:

Week 4, Week 8

测量方法:

Cantonese Hearing In Noise Test (CHINT)

Measure time point of outcome:

Week 4, Week 8

Measure method:

Cantonese Hearing In Noise Test (CHINT)

指标中文名:

Self-rated hearing qualities associated with device use

指标类型:

主要指标 

Outcome:

Self-rated hearing qualities associated with device use

Type:

Primary indicator 

测量时间点:

Week 4, Week 8

测量方法:

Speech, Spatial and Qualities of Hearing scale (SSQ12)

Measure time point of outcome:

Week 4, Week 8

Measure method:

Speech, Spatial and Qualities of Hearing scale (SSQ12)

指标中文名:

User experience with the adhesive bone-conduction device

指标类型:

次要指标 

Outcome:

User experience with the adhesive bone-conduction device

Type:

Secondary indicator 

测量时间点:

Week 8

测量方法:

ADHEAR Use and Satisfaction Questionnaire

Measure time point of outcome:

Week 8

Measure method:

ADHEAR Use and Satisfaction Questionnaire

采集人体标本:

Collecting sample(s)
from participants:

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 years
最大 Max age 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

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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:

Not stated

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

Not stated

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-10-08
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