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| ID | Type | Description | Link |
|---|---|---|---|
| 2025350H | Other Identifier | BeijingSU |
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What are the requirements for participating in this study?
informed consent
Please read the following carefully before you decide to participate in this study. If you are willing to participate, please fill out the informed consent form.
Insomnia, a condition marked by difficulty falling asleep or maintaining deep sleep, is characterized by persistent sleep disturbances. It often manifests alongside daytime fatigue, drowsiness, irritability, and in severe cases, depressive or anxious symptoms. Epidemiological studies indicate that 6% to 10% of adults experience insomnia, with nearly half of the population suffering from it annually. Women and older adults are particularly vulnerable. The primary treatment goals are to improve sleep quality and alleviate functional impairments caused by sleep disorders. Current approaches include psychotherapy (such as cognitive behavioral therapy, group behavioral therapy, or brief cognitive behavioral therapy) and medication (sleep aids, antidepressants, antipsychotics, and melatonin). Alternative therapies like acupuncture and herbal medicine are also used, though their clinical effectiveness remains unproven. The American Medical Association's Evidence-Based Clinical Practice Guidelines recommend cognitive behavioral therapy for chronic insomnia (strongly recommended, moderate evidence), while medication use requires careful evaluation of efficacy, side effects, and cost-effectiveness (low-quality evidence). Long-term use of sleep or psychiatric medications should only be considered for strictly defined conditions, as potential risks of dependency and adverse reactions remain a concern for both patients and clinicians.
Although traditional drug therapy can improve sleep in the short term, long-term use poses issues such as dependence and side effects, making it difficult to serve as an ideal long-term intervention. Therefore, exploring a safe, effective, and non-pharmacological intervention method has become an important direction in current insomnia treatment research. Tai Chi, as a traditional Chinese health-preserving method, integrates breathing regulation, mental guidance, and slow limb movements, emphasizing the unity of body and mind and the balance of yin and yang. Numerous studies have confirmed its positive effects in regulating the nervous system, alleviating anxiety, and improving sleep quality. Recent empirical studies both domestically and internationally have also found that regular practice of Tai Chi can effectively improve sleep quality, shorten the time to fall asleep, and prolong the deep sleep stage, particularly showing significant efficacy for middle-aged and elderly insomnia patients.
What are the requirements for participating in this study?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | If subjects are eligible to participate in this study, they will be randomly assigned by the doctor to undergo the following two phases, including a screening and baseline assessment period, an intervention period, and a follow-up period. The specific assessments conducted in each phase are as follows: The entire trial consists of 3 stages, with each stage comprising 2 periods (a test period or a control period, each lasting 1 week/2 weeks). After enrollment, patients will be randomly allocated to either the test period (Tai Chi) or the control period (walking). During the study, subjects will be required to cooperate with doctors to complete relevant questionnaires and follow-up assessments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tai Chi and Walking | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire designed to assess subjective sleep quality over a 1-month period. Developed by Buysse et al. in 1989, it consists of 19 individual items categorized into 7 components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored on a 0-3 scale, with total scores ranging from 0 to 21. A total score ≥ 7 indicates poor sleep quality, while a score < 7 reflects good sleep quality. The PSQI is recognized for its simplicity, reliability, and validity across diverse populations, including healthy individuals, patients with chronic diseases, and those with sleep disorders. It is extensively employed in clinical research, epidemiological studies, and clinical practice to evaluate sleep outcomes, particularly in fields such as medicine, psychology, public health, and complementary and altern | 8 weeks |
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Inclusion Criteria:
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he study population consists of individuals aged 40 to 69 years diagnosed with insomnia, defined according to the diagnostic criteria of the International Classification of Sleep Disorders (ICSD-3) or the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Eligible participants typically report persistent sleep disturbances (e.g., difficulty falling asleep, frequent nighttime awakenings, early-morning awakening, or non-restorative sleep) lasting at least 3 months, occurring at least 3 nights per week, and causing significant daytime impairment (such as fatigue, mood disturbances, cognitive dysfunction, or reduced work/activity capacity).
This age group (40-69 years) is characterized by a high prevalence of insomnia, often associated with physiological changes (e.g., declining sleep efficiency, altered circadian rhythms), chronic comorbidities (e.g., hypertension, diabetes, musculoskeletal disorders), psychological stress, or lifestyle factors (e.g., sedentary behavior, irreg
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangji X PENG, Master | Contact | +8615210900779 | pxj0633@163.com |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D026302 | Tai Ji |
| D016138 | Walking |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
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|
| D001523 |
| Mental Disorders |
| D026741 |
| Physical Therapy Modalities |
| D008124 | Locomotion |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D015444 | Exercise |
| D009043 | Motor Activity |