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Neurobiological mechanisms underlying the effects of mindfulness-based intervention and Tai Chi Chuan on sleep disturbance in older people
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注册号：

Registration number：

 ChiCTR2100048750 

最近更新日期：

Date of Last Refreshed on：

 2021-07-16 01:12:20 

注册时间：

Date of Registration：

 2021-07-16 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Neurobiological mechanisms underlying the effects of mindfulness-based intervention and Tai Chi Chuan on sleep disturbance in older people

Public title：

Neurobiological mechanisms underlying the effects of mindfulness-based intervention and Tai Chi Chuan on sleep disturbance in older people

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Neurobiological mechanisms underlying the effects of mindfulness-based intervention and Tai Chi Chuan on sleep disturbance in older people

Scientific title：

Neurobiological mechanisms underlying the effects of mindfulness-based intervention and Tai Chi Chuan on sleep disturbance in older people

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：

Chan Ho Wan Sunny 

研究负责人：

Chan Ho Wan Sunny 

Applicant：

Chan Ho Wan Sunny 

Study leader：

Chan Ho Wan Sunny 

申请注册联系人电话：

Applicant telephone：

 +852 27664676

研究负责人电话：

Study leader's
telephone：

+852 27664676

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：

 sunny.hw.chan@polyu.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 sunny.hw.chan@polyu.edu.hk

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：

Room ST502, The Hong Kong Polytechnic University, Hong Kong, China

研究负责人通讯地址：

Room ST502, The Hong Kong Polytechnic University, Hong Kong, China

Applicant address：

Room ST502, The Hong Kong Polytechnic University, Hong Kong, China

Study leader's address：

Room ST502, The Hong Kong Polytechnic University, Hong Kong, 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：

香港理工大學

Applicant's institution：

The Hong Kong Polytechnic University

研究负责人所在单位：

香港理工大學

Affiliation of the Leader：

The Hong Kong Polytechnic 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：

 HSEARS20210305001

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：

Human Subjects Ethics Sub-committee, Departmental Research Committee, The Hong Kong Polytechnic University

Name of the ethic committee：

Human Subjects Ethics Sub-committee, Departmental Research Committee, The Hong Kong Polytechnic University

伦理委员会批准日期：

Date of approved by ethic committee：

 2013-08-26 00:00:00

伦理委员会联系人：

Prof Marco Pang

Contact Name of the ethic committee：

Prof Marco Pang

伦理委员会联系地址：

The Hong Kong Polytechnic University

Contact Address of the ethic committee：

The Hong Kong Polytechnic University

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：

Research Grants Council

Primary sponsor：

Research Grants Council

研究实施负责（组长）单位地址：

7/F., Shui On Centre, 6-8 Harbour Road, Wanchai, Hong Kong, China

Primary sponsor's address：

7/F., Shui On Centre, 6-8 Harbour Road, Wanchai, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

General Research Fund

Source(s) of funding：

General Research Fund

研究疾病：

Sleep Disturbance  

Target disease：

Sleep Disturbance

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1. To provide novel insight into the additive and synergistic effects of an mindfulness-based intervention (MBI) group and a Tai Chi Chuan (TCC) group for sleep disturbance in older people over a 12-month follow-up period by comparison to a sleep hygiene education (SHE) control group. 2. To explore the lived experience of individuals in terms of sleep quality and the impact, if any, of different interventions. 3. To provide empirical support to guide clinical practice regarding the judicious use and feasibility of different types of mind-body-based complementary and alternative medicine (CAM) for sleep problems in the elderly population. 4. To perform cost benefit analysis of different mind-body CAMs after collecting qualitative data from participants. 5. To examine the mediating roles of salivary cortisol and brain-derived neurotrophic factor (BDNF) as biological mechanisms underlying the potential beneficial effects of MBI and TCC on sleep quality, respectively. 6. To examine the mediating roles of frontal midline theta and brain arousal level as neurological mechanisms underlying the anticipated beneficial effects of MBI and TCC on sleep quality, respectively. 7. To enrich the etiological model of sleep disturbance through focusing on the effects of MBI and TCC on rumination and arousal level, respectively.  

Objectives of Study：

1. To provide novel insight into the additive and synergistic effects of an mindfulness-based intervention (MBI) group and a Tai Chi Chuan (TCC) group for sleep disturbance in older people over a 12-month follow-up period by comparison to a sleep hygiene education (SHE) control group. 2. To explore the lived experience of individuals in terms of sleep quality and the impact, if any, of different interventions. 3. To provide empirical support to guide clinical practice regarding the judicious use and feasibility of different types of mind-body-based complementary and alternative medicine (CAM) for sleep problems in the elderly population. 4. To perform cost benefit analysis of different mind-body CAMs after collecting qualitative data from participants. 5. To examine the mediating roles of salivary cortisol and brain-derived neurotrophic factor (BDNF) as biological mechanisms underlying the potential beneficial effects of MBI and TCC on sleep quality, respectively. 6. To examine the mediating roles of frontal midline theta and brain arousal level as neurological mechanisms underlying the anticipated beneficial effects of MBI and TCC on sleep quality, respectively. 7. To enrich the etiological model of sleep disturbance through focusing on the effects of MBI and TCC on rumination and arousal level, respectively.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

Elderly people with comorbid diagnoses of organic brain syndrome, substance misuse, psychosis, or intellectual disabilities will be excluded.

Exclusion criteria：

Elderly people with comorbid diagnoses of organic brain syndrome, substance misuse, psychosis, or intellectual disabilities will be excluded.

研究实施时间：

Study execute time：

从 From 2022-01-01 00:00:00至 To 2024-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-01-01 00:00:00 至 To 2022-09-30 00:00:00

干预措施：

Interventions：

组别：

Mindfulness-based intervention (MBI)

样本量：

 52

Group：

Mindfulness-based intervention (MBI)

Sample size：

干预措施：

Mindfulness-based intervention (MBI)

干预措施代码：

Intervention：

Mindfulness-based intervention

Intervention code：

组别：

Tai Chi Chuan (TCC) group

样本量：

 52

Group：

Tai Chi Chuan (TCC) group

Sample size：

干预措施：

Tai Chi Chuan

干预措施代码：

Intervention：

Tai Chi Chuan

Intervention code：

组别：

Sleep hygiene education (SHE) control group

样本量：

 52

Group：

Sleep hygiene education (SHE) control group

Sample size：

干预措施：

Sleep hygiene education

干预措施代码：

Intervention：

Sleep hygiene education

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)：

 香港理工大學 

单位级别：

 大學 

Institution
hospital：

The Hong Kong Polytechnic University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Subjective sleep quality

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：

Objective sleep quality

指标类型：

次要指标

Outcome：

Objective sleep quality

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Subjective rumination

指标类型：

次要指标

Outcome：

Subjective rumination

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Subjective hyperarousal

指标类型：

次要指标

Outcome：

Subjective hyperarousal

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Brain arousal level

指标类型：

附加指标

Outcome：

Brain arousal level

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Frontal midline theta

指标类型：

附加指标

Outcome：

Frontal midline theta

Type：

Additional 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：

Blood

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

Saliva

组织：

Sample Name：

Saliva

Tissue：

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 60 岁 years
最大 Max age N/A 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）：

The PI will generate the random number sequence by a computer-generated randomization list.

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

The PI will generate the random number sequence by a computer-generated randomization list.

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：

Not stated

Blinding：

Not stated

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）：

Available upon request

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

Available upon request

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：

Any information obtained in this study will remain very strictly confidential, will be known to no-one, and will be used for research purposes only. Codes, not names, are used on all test instruments to protect confidentiality. Data will be stored in encrypted file in the computer. To protect patient privacy, all research data and hard documents would be handled with significant care with regard to handling/storage/destruction of patients’ medical records. They would be locked in cabinets where the department or ward keeps participants’ confidential information.

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

Any information obtained in this study will remain very strictly confidential, will be known to no-one, and will be used for research purposes only. Codes, not names, are used on all test instruments to protect confidentiality. Data will be stored in encrypted file in the computer. To protect patient privacy, all research data and hard documents would be handled with significant care with regard to handling/storage/destruction of patients’ medical records. They would be locked in cabinets where the department or ward keeps participants’ confidential information.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-07-16 01:12:21
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