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Effect of bedtime changes on blood pressure in children and adolescents
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注册号:

Registration number:

ChiCTR-TRC-14004316 

最近更新日期:

Date of Last Refreshed on:

2016-08-14 

注册时间:

Date of Registration:

2014-03-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

改變睡眠時間對兒童及青少年的血壓之影響-隨機交叉研究 

Public title:

Effect of bedtime changes on blood pressure in children and adolescents 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

改變睡眠時間對兒童及青少年的血壓之影響-隨機交叉研究 

Scientific title:

A randomized controlled study of the effect of changes in bedtime on blood pressure in children and adolescents 

研究课题代号(代码):

Study subject ID:

CRE-2013.683-T 

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_CCT00397 

申请注册联系人:

Mr. Au Chun Ting 

研究负责人:

Prof. Albert Martin Li 

Applicant:

Mr. Au Chun Ting 

Study leader:

Prof. Albert Martin Li 

申请注册联系人电话:

Applicant telephone:

+852 2632 2917 

研究负责人电话:

Study leader's telephone:

+852 2632 2982 

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/236 

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/236 

申请注册联系人通讯地址:

RM 94034, 7/F, Clinical Sciences Building, Prince of Wales Hospital, Shatin, New Territories, Hong Kong SAR, China 

研究负责人通讯地址:

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

Applicant address:

RM 94034, 7/F, Clinical Sciences Building, Prince of Wales Hospital, Shatin, New Territories, Hong Kong SAR, China 

Study leader's address:

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

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, Faculty of Medicine, The Chinese University of Hong Kong 

Applicant's institution:

Department of Paediatrics, Faculty of Medicine, 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:

N/A 

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:

The Chinese University of Hong Kong 

Name of the ethic committee:

The Chinese University of Hong Kong 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-01-15 

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:

Department of Paediatrics, CUHK 

Primary sponsor:

Department of Paediatrics, CUHK 

研究实施负责(组长)单位地址:

Department of Paediatrics, CUHK 

Primary sponsor's address:

Department of Paediatrics, CUHK 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中國

省(直辖市):

香港特別行政區

市(区县):

Country:

China

Province:

Hong Kong

City:

单位(医院):

Department of Paediatrics, CUHK

具体地址:

Institution
hospital:

Department of Paediatrics, CUHK

Address:

经费或物资来源:

Department of Paediatrics, CUHK 

Source(s) of funding:

Department of Paediatrics, CUHK 

研究疾病:

睡眠障碍 

Target disease:

Sleep deprivation 

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:

I期临床试验 

Study phase:

研究目的:

改變睡眠時間對兒童及青少年的血壓之影響 

Objectives of Study:

Effect of bedtime changes on blood pressure in children and adolescents 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. Children and adolescents aged between 6-18 years; 2. Parent- or self-reported time in bed of <7 hours/night; 3. Normal weight (Body mass index <85th percentile of local norm); 4. Non-hypertensive (clinic BP <95th percentile of local norm); 5. Written informed consent and assent obtained from parents and children. 

Inclusion criteria

1. Children and adolescents aged between 6-18 years; 2. Parent- or self-reported time in bed of <7 hours/night; 3. Normal weight (Body mass index <85th percentile of local norm); 4. Non-hypertensive (clinic BP <95th percentile of local norm); 5. Written informed consent and assent obtained from parents and children. 

排除标准:

1. Diagnosis of a medical or psychiatric condition or use of current medication that may affect sleep and BP; 2. Parent reports habitual snoring (≥3 nights per week in the past 12 months). 

Exclusion criteria:

1. Diagnosis of a medical or psychiatric condition or use of current medication that may affect sleep and BP; 2. Parent reports habitual snoring (≥3 nights per week in the past 12 months). 

研究实施时间:

Study execute time:

FromTo  

干预措施:

Interventions:

组别:

样本量:

40

Group:

Two groups

Sample size:

干预措施:

干预措施代码:

Intervention:

Subjects in group A will be instructed to extend their time in bed (TIB) by 1h from baseline in study week 1, and to further increase their TIB by another hour in study week 2. They will then be instructed to maintain the increased TIB for two more weeks (study weeks 3 and 4) versus Subjects in group B will be instructed to maintain their time in bed (TIB) as in the baseline week for two more weeks (study weeks 1 and 2). They will then need to extend their TIB by 1h in study week 3 and further e

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):

Chinese University of Hong Kong 

单位级别:

Chinese University of Hong Kong 

Institution
hospital:

Department of Paediatrics, CUHK  

Level of the institution:

Department of Paediatrics, CUHK 

测量指标:

Outcomes:

指标中文名:

24-hour ambulatory systolic and diastolic blood pressure at the end of study

指标类型:

主要指标 

Outcome:

24-hour ambulatory systolic and diastolic blood pressure at the end of study

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Actigraphy measured sleep quantity and quality at the end of study

指标类型:

次要指标 

Outcome:

Actigraphy measured sleep quantity and quality at the end of study

Type:

Secondary 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:

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 18 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):

Random

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

Random

盲法:

Blinding:

Single-blind

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:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-03-03
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