今天是:2019-07-21 星期日

失眠伴抑郁与膳食炎症指数的相关性研究
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注册号:

Registration number:

ChiCTR1900022443 

最近更新日期:

Date of Last Refreshed on:

2019-04-11 

注册时间:

Date of Registration:

2019-04-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

失眠伴抑郁与膳食炎症指数的相关性研究 

Public title:

Correlation between dietary inflammation index and insomnia with depression  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

失眠伴抑郁与膳食炎症指数的相关性研究 

Scientific title:

Correlation between dietary inflammation index and insomnia with depression  

研究课题代号(代码):

Study subject ID:

2018CR009 

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:

2018CR009 

申请注册联系人:

赖晓英 

研究负责人:

赖晓英 

Applicant:

Xiaoying Lai 

Study leader:

Xiaoying Lai 

申请注册联系人电话:

Applicant telephone:

+86 13268122018 

研究负责人电话:

Study leader's telephone:

+86 13268122018 

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:

617367790@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

617367790@qq.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:

广东省广州市白云区广州大道北1838号 

研究负责人通讯地址:

广东省广州市白云区 

Applicant address:

1838 Guangzhou Avenue North, Baiyun District, Guangzhou, Guangdong, China 

Study leader's address:

1838 Guangzhou Avenue North, Baiyun District, Guangzhou, Guangdong, 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:

南方医科大学南方医院健康管理科 

Applicant's institution:

Department of Health Management, Southern Medical University, Southern 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:

NFEC-2019-059 

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:

南方医科大学南方医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Southern Hospital of Southern Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-04-04 

伦理委员会联系人:

胡兴媛 

Contact Name of the ethic committee:

Xingyuan Hu 

伦理委员会联系地址:

广东省广州市白云区广州大道北1838号 

Contact Address of the ethic committee:

1838 Guangzhou Avenue North, Baiyun District, Guangzhou, Guangdong, China 

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:

南方医科大学南方医院 

Primary sponsor:

Southern Medical University, Southern Hospital 

研究实施负责(组长)单位地址:

广东省广州市白云区广州大道北1838号 

Primary sponsor's address:

1838 Guangzhou Avenue North, Baiyun District, Guangzhou, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong Province

City:

Guangzhou

单位(医院):

南方医科大学南方医院

具体地址:

白云区广州大道北1838号

Institution
hospital:

Southern Medical University, Southern Hospital

Address:

1838 Guangzhou Avenue North, Baiyun District

经费或物资来源:

南方医科大学南方医院“临床研究专项”(2018CR009) 

Source(s) of funding:

Clinical Research Program of Nanfang Hospital, Southern Medical University(2018CR009) 

研究疾病:

失眠及抑郁 

Target disease:

insomnia and depression 

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:

分析DII评分与失眠伴抑郁的相关关系,探索促炎症膳食与失眠伴抑郁的相关性。 分析有益于失眠伴抑郁的膳食模式,为失眠伴抑郁的防治提出建议。 

Objectives of Study:

To analyze the relationship between DII score and insomnia with depression, and to explore the correlation between pro-inflammatory diet and insomnia with depression. Exploring a dietary pattern that is beneficial to insomnia and depression and providing suggestions for prevention and treatment of insomnia with depression. 

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:

广东省常住居民,年龄≥18岁。 

Inclusion criteria

Permanent resident of Guangdong Province (more than 2 years), aged ≥ 18 years. 

排除标准:

近期刻意改变生活习惯者(>6个月)、异常的总能量摄入者(男性<800或>4000kcal/d,女性<500或>3500 kcal/d)、膳食习惯无规律者、数据缺失不全者、伴严重躯体疾病者(哮喘、心脑血管疾病、类风湿关节炎、慢性肾功能衰竭等)、妊娠/哺乳期妇女及自我报告有不宁腿综合征、呼吸睡眠暂停综合征者。 

Exclusion criteria:

Those who have deliberately changed their lifestyle recently (>6 months), abnormal total energy intake (male <800 or >4000 kcal/d, women <500 or >3500 kcal/d), irregular eating habits, data incomplete. Those with severe physical diseases (asthma, cardiovascular and cerebrovascular diseases, rheumatoid arthritis, chronic renal failure), pregnant/lactating women, and self-reported patients with restless legs syndrome and respiratory sleep apnea syndrome. 

研究实施时间:

Study execute time:

From2019-01-01To 2021-12-31 

干预措施:

Interventions:

组别:

失眠伴抑郁组

样本量:

212

Group:

insomnia with depression group

Sample size:

干预措施:

N/A

干预措施代码:

N/A

Intervention:

N/A

Intervention code:

组别:

无失眠和抑郁组

样本量:

212

Group:

non-insomnia and non-depression group

Sample size:

干预措施:

N/A

干预措施代码:

N/A

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

南方医院 

单位级别:

三级甲等医院 

Institution
hospital:

Nanfang Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

膳食炎症指数

指标类型:

主要指标 

Outcome:

dietary inflammation index

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:

血液

组织:

N/A

Sample Name:

blood

Tissue:

N/A

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

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 18 years
最大 Max age 80 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

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):

Revman, http://www.medresman.org

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

Revman, http://www.medresman.org

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:

1. 使用病例记录表(CRF)采集受试者的过去一年的生活方式习惯(饮食、运动、吸烟、饮酒)及过去一段时间的睡眠心理状态(失眠、抑郁、嗜睡等),2. 使用Epidata进行CRF中的数据录入与整理,导入SPSS进行统计分析。

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

1. To use the case record form (CRF)to collect the subject's lifestyle habits (diet, exercise, smoking, drinking) and the psychological and sleep states (insomnia, depression, lethargy, etc.) 2. To use Epidata to entry and sorting data in CRF, and import into the SPSS for statistical analysis.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-04-11
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