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【ChiCTR2100048750】Neurobiological mechanisms underlying the effects of mindfulness-based intervention and Tai Chi Chuan on sleep disturbance in older people

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基本信息

登记号

ChiCTR2100048750

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2021-07-16

临床申请受理号

靶点

适应症

Sleep Disturbance

试验通俗题目

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

试验专业题目

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

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联系人邮编

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临床试验信息

试验目的

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.

试验分类

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试验类型

随机平行对照

试验分期

探索性研究/预试验

随机化

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

盲法

Not stated

试验项目经费来源

General Research Fund

试验范围

目标入组人数

实际入组人数

第一例入组时间

2022-01-01

试验终止时间

2024-12-31

是否属于一致性

入选标准

(1) aged 60 years or above; (2) classified as experiencing sleep disturbances (poor sleep quality indicated by a score >5 on the PSQI (Tsai et al., 2005)); (3) primary education level or above and able to communicate in Cantonese; (4) able to give informed consent; (5) no previous experience with meditation or other mind-body techniques (e.g., Tai Chi or yoga).；

排除标准

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

研究者信息

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试验机构

Research Grants Council

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研究负责人邮编