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教育家長對改善學前兒童睡眠的成效 - 隨機對照研究
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注册号：

Registration number：

 ChiCTR1800019013 

最近更新日期：

Date of Last Refreshed on：

 2018-10-21 13:30:04 

注册时间：

Date of Registration：

 2018-10-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

教育家長對改善學前兒童睡眠的成效 - 隨機對照研究

Public title：

Randomised controlled study to examine the efficacy of sleep education on extending sleep duration of pre-school children

注册题目简写：

English Acronym：

研究课题的正式科学名称：

教育家長對改善學前兒童睡眠的成效 - 隨機對照研究

Scientific title：

Randomised controlled study to examine the efficacy of sleep education on extending sleep duration of pre-school children

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_CCRB00627

申请注册联系人：

Chun-Ting Au 

研究负责人：

Albert Marin Li 

Applicant：

Chun-Ting Au 

Study leader：

Albert Marin Li 

申请注册联系人电话：

Applicant telephone：

 +852 35052917

研究负责人电话：

Study leader's
telephone：

+852 26322982

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：

 junau@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 albertmli@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/604

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/604

申请注册联系人通讯地址：

Department of Paediatrics, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, N.T., Hong Kong SAR, China

研究负责人通讯地址：

Department of Paediatrics, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, N.T., Hong Kong SAR, China

Applicant address：

Department of Paediatrics, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, N.T., Hong Kong SAR, China

Study leader's address：

Department of Paediatrics, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, N.T., 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 Paediatrics, Prince of Wales Hospital

Applicant's institution：

Department of Paediatrics, Prince of Wales Hospital

研究负责人所在单位：

Department of Paediatrics, Prince of Wales Hospital

Affiliation of the Leader：

Department of Paediatrics, Prince of Wales Hospital

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：

 2018.222-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：

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：

 2018-05-15 00:00:00

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：

Prince of Wales Hospital, Chinese University of Hong Kong

Primary sponsor：

Prince of Wales Hospital, Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Prince of Wales Hospital, Chinese University of Hong Kong

Primary sponsor's address：

Prince of Wales Hospital, 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：

Departmental funding

Source(s) of funding：

Departmental funding

研究疾病：

睡眠  

Target disease：

Short sleep duration

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

教育家長對改善學前兒童睡眠的成效  

Objectives of Study：

To examine the efficacy of sleep education on extending sleep duration of pre-school children

药物成份或治疗方案详述：

The main caregiver(s) of the subjects will have to attend three educational workshop sessions delivered by the principal investigator over consecutive weeks (week 1-3). General principles on functions and importance of sleep, factors that influence preschooler children’s sleep and ways to help extend sleep duration will be discussed. Each workshop presentation will last for around 40 minutes and then time will be allocated for group discussion and design of individual management strategy for each family. For each workshop session, we will limit the number of families to a maximum of 10 to allow for more in-depth discussion between family members and the investigator. Weekly (week 1-7) telephone interview will be conducted by research personnel to answer queries, provide support and reinforce strategies decided for that particular family, followed by a 6-week (week 8-13) maintenance period. 

Description for medicine or protocol of treatment in detail：

The main caregiver(s) of the subjects will have to attend three educational workshop sessions delivered by the principal investigator over consecutive weeks (week 1-3). General principles on functions and importance of sleep, factors that influence preschooler childrens sleep and ways to help extend sleep duration will be discussed. Each workshop presentation will last for around 40 minutes and then time will be allocated for group discussion and design of individual management strategy for each family. For each workshop session, we will limit the number of families to a maximum of 10 to allow for more in-depth discussion between family members and the investigator. Weekly (week 1-7) telephone interview will be conducted by research personnel to answer queries, provide support and reinforce strategies decided for that particular family, followed by a 6-week (week 8-13) maintenance period. 

纳入标准：

Inclusion criteria

排除标准：

1. Presence of habitual snoring;
2. Acute physical illness within 4 weeks of recruitment;
3. Chronic illness that may affect the child’s sleep pattern for example poorly controlled asthma and or eczema;
4. Use of any medication or diagnosed to have developmental or psychiatric disorder.

Exclusion criteria：

1. Presence of habitual snoring;
2. Acute physical illness within 4 weeks of recruitment;
3. Chronic illness that may affect the childs sleep pattern for example poorly controlled asthma and or eczema;
4. Use of any medication or diagnosed to have developmental or psychiatric disorder.

研究实施时间：

Study execute time：

从 From 1990-01-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2018-11-01 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 200

Group：

Two groups

Sample size：

干预措施：

Workshop and telephone interview, 3 workshops over consecutive weeks (week 1-3), and 7 telephone interviews (week 1-7) for seven weeks versus Telephone interview for seven weeks, weekly

干预措施代码：

Intervention：

Workshop and telephone interview, 3 workshops over consecutive weeks (week 1-3), and 7 telephone interviews (week 1-7) for seven weeks versus Telephone interview for seven weeks, weekly

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)：

 Prince of Wales Hospital, Chinese University of Hong Kong 

单位级别：

 Prince of Wales Hospital, Chinese University of Hong Kong 

Institution
hospital：

Prince of Wales Hospital, Chinese University of Hong Kong

Level of the institution：

Prince of Wales Hospital, Chinese University of Hong Kong

测量指标：

Outcomes：

指标中文名：

Sleep duration

指标类型：

主要指标

Outcome：

Sleep duration

Type：

Primary indicator

测量时间点：

Week 0, Week 7, Week 13

测量方法：

Actigraphy and sleep diary

Measure time point of outcome：

Week 0, Week 7, Week 13

Measure method：

Actigraphy and sleep diary

指标中文名：

Sleep efficiency

指标类型：

次要指标

Outcome：

Sleep efficiency

Type：

Secondary indicator

测量时间点：

Week 0, Week 7, Week 13

测量方法：

Actigraphy

Measure time point of outcome：

Week 0, Week 7, Week 13

Measure method：

Actigraphy

指标中文名：

Wake after sleep onset (WASO)

指标类型：

次要指标

Outcome：

Wake after sleep onset (WASO)

Type：

Secondary indicator

测量时间点：

Week 0, Week 7, Week 13

测量方法：

Actigraphy

Measure time point of outcome：

Week 0, Week 7, Week 13

Measure method：

Actigraphy

指标中文名：

Sleep latency

指标类型：

次要指标

Outcome：

Sleep latency

Type：

Secondary indicator

测量时间点：

Week 0, Week 7, Week 13

测量方法：

Actigraphy

Measure time point of outcome：

Week 0, Week 7, Week 13

Measure method：

Actigraphy

指标中文名：

Behavioural problem score

指标类型：

次要指标

Outcome：

Behavioural problem score

Type：

Secondary indicator

测量时间点：

Week 0, Week 7, Week 13

测量方法：

Child Behaviour Checklist (CBCL)

Measure time point of outcome：

Week 0, Week 7, Week 13

Measure method：

Child Behaviour Checklist (CBCL)

指标中文名：

Sleep problem score

指标类型：

次要指标

Outcome：

Sleep problem score

Type：

Secondary indicator

测量时间点：

Week 0, Week 7, Week 13

测量方法：

Children Sleep Habit Questionnaire (CSHQ)

Measure time point of outcome：

Week 0, Week 7, Week 13

Measure method：

Children Sleep Habit Questionnaire (CSHQ)

指标中文名：

Objective measures of attention

指标类型：

次要指标

Outcome：

Objective measures of attention

Type：

Secondary indicator

测量时间点：

Week 0, Week 7, Week 13

测量方法：

Conners Kiddle Continuous Performance Test 2nd EditionTM (K-CPT 2TM)

Measure time point of outcome：

Week 0, Week 7, Week 13

Measure method：

Conners Kiddle Continuous Performance Test 2nd EditionTM (K-CPT 2TM)

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 3 岁 years
最大 Max age 5 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）：

Randomized

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

Randomized

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：

Single-blind

Blinding：

Single-blind

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：

Not stated

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

Not stated

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2018-10-21 13:30:04
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