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口服褪黑素对模拟ICU噪光环境下健康志愿者睡眠质量的影响
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注册号:

Registration number:

ChiCTR-IPR-14005458 

最近更新日期:

Date of Last Refreshed on:

2016-01-05 

注册时间:

Date of Registration:

2014-11-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

口服褪黑素对模拟ICU噪光环境下健康志愿者睡眠质量的影响 

Public title:

Effect of oral melatonin and wearing earplugs and eye masks on nocturnal sleep in healthy subjects in a simulated intensive care unit environment 

研究课题的正式科学名称:

口服褪黑素对模拟ICU噪光环境下健康志愿者睡眠质量的影响 

Scientific title:

Effect of oral melatonin and wearing earplugs and eye masks on nocturnal sleep in healthy subjects in a simulated intensive care unit environment 

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:

席修明 

研究负责人:

沈翎 

Applicant:

Xi xiuming 

Study leader:

Shen Ling 

申请注册联系人电话:

Applicant telephone:

+86 13599058877 

研究负责人电话:

Study leader's telephone:

+86 13705038829 

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:

xxm_fxyy@sina.cn 

研究负责人电子邮件:

Study leader's E-mail:

vivian198543@163.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:

北京市西城区复兴门外大街甲20号复兴医院北楼9层ICU 

研究负责人通讯地址:

福建省福州市鼓楼区八一七中路福州市儿童医院耳鼻喉科 

Applicant address:

Department of Critical Care Medicine, Beijing Fuxing Hospital, Capital Medical University, 20A Fu Xing Men Wai Da Jie, Xicheng District, Beijing 

Study leader's address:

Department of Otorhinolaryngology, Fuzhou Children's Hospital of Fujian Province, Teaching Hospital of Fujian Medical University, Ba Yi Qi Zhong Road, Gulou District, Fuzhou, Fujian 

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:

首都医科大学附属复兴医院 

Applicant's institution:

Beijing Fuxing Hospital, Capital Medical University 

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:

(2014)伦审【药】第( 001 )号 

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:

福建省福州市儿童医院伦理委员会 

Name of the ethic committee:

the ethics committee of Fuzhou Chrildren Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-09-01 

研究实施负责(组长)单位:

福建省福州市儿童医院 

Primary sponsor:

Fuzhou Children's Hospital of Fujian Province 

研究实施负责(组长)单位地址:

福建省福州市鼓楼区八一七中路福州市儿童医院耳鼻喉科 

Primary sponsor's address:

Department of Otorhinolaryngology, Fuzhou Children's Hospital of Fujian Province, Teaching Hospital of Fujian Medical University, Ba Yi Qi Zhong Road, Gulou District, Fuzhou, Fujian 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

科室课题基金 

Source(s) of funding:

subject fund 

研究疾病:

ICU睡眠剥夺 

Target disease:

ICU 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:

预试验 

Study phase:

Pilot study 

研究目的:

观察和比较口服褪黑素及佩戴耳塞眼罩对于模拟ICU环境下健康志愿者夜间睡眠的影响 

Objectives of Study:

In the study, we aim to investigate and compare the effectiveness of oral melatonin and wearing earplugs and eye masks on sleep quality in healthy subjects who were exposed to a simulated ICU situation. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

1、年龄大于18岁; 2、BMI<26 kg/m2; 3、非吸烟者 4、PSQI≤7; 5、作息每日9:00PM-00:00AM就寝,每日睡眠时间6-9小时 

Inclusion criteria

Subjects were included in the study if they were older than 18 years of age, body mass index (BMI) less than 26 kg/m2, non-smoker, had scores of 7 or less on the Pittsburgh Sleep Quality Index (PSQI), usually went to bed between 9 pm and midnight and had habitual time in bed between 6 and 9 hours per night. 

排除标准:

1、有睡眠紊乱的病史 2、耳聋、眼盲 3、酒精、药物滥用 4、近期有轮班或跨时区旅游 

Exclusion criteria:

Exclusion criteria included a history or current diagnosis of other sleep disorders (such as restless leg syndrome, periodic leg movements with arousals, narcolepsy, rapid eye movement (REM) Behavior Disorder, circadian rhythm sleep disorder, breathing related sleep disorder, or parasomnias), reduced hearing acuity (more than 20-dB hearing loss at a single frequency, as tested with audiometer Entomed SA 201) and blindness, a history of alcohol or medication abuse. Participants with an occupational history that included shift work or recent significant travel across three or more time zones within the prior two weeks were also excluded. In addition, after a screening PSG, participants with an apnea-hypopnea index more than 15 or a periodic leg movement arousal index more than 15 and known allergy to melatonin were also excluded. 

研究实施时间:

Study execute time:

From2014-12-01To 2015-02-28 

干预措施:

Interventions:

组别:

ICU噪光环境组

样本量:

10

Group:

ICU noise and light group

Sample size:

干预措施:

模拟ICU噪光环境

干预措施代码:

Intervention:

simulated ICU noise and light

Intervention code:

组别:

耳塞眼罩组

样本量:

10

Group:

earplugs and eyemasks group

Sample size:

干预措施:

佩戴耳塞眼罩

干预措施代码:

Intervention:

wearing earplugs and eyemasks

Intervention code:

组别:

褪黑素组

样本量:

10

Group:

melatonin group

Sample size:

干预措施:

口服褪黑素

干预措施代码:

Intervention:

oral melatonin

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

总睡眠时间

指标类型:

主要指标 

Outcome:

total sleep time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

NREM 1期

指标类型:

主要指标 

Outcome:

NREM stage1

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

NREM 2期

指标类型:

主要指标 

Outcome:

NREM stage 2

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

慢波睡眠

指标类型:

主要指标 

Outcome:

SWS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

REM

指标类型:

主要指标 

Outcome:

REM

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

觉醒指数

指标类型:

主要指标 

Outcome:

arousal index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

主观睡眠质量

指标类型:

主要指标 

Outcome:

subjective sleep quality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

焦虑水平

指标类型:

主要指标 

Outcome:

anxiety level

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:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 10 years
最大 Max age 70 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):

由非参与治疗者按照电脑随机数字表法产生随机序列

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

Randomization was performed using a computer-generated schedule independent of treatment personnel.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/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):

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-11-10
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