An Integration of Tai Chi and Repetitive Transcranial Magnetic Stimulation for Sleep Disturbance in Older Adults
- Conditions
- Sleep Disturbance
- Registration Number
- NCT05808517
- Lead Sponsor
- The Hong Kong Polytechnic University
- Brief Summary
The investigators designed an RCT aimed at 1) exploring the effectiveness of combining TC with rTMS for synergistically improving sleep disturbances in community-dwelling older adults, 2) investigating the mediating roles of arousal states as the underlying mechanism of the potential beneficial effects, and 3) evaluating the feasibility and safety to inform the clinical practice. The investigators hypothesized that integrating TC and rTMS can affect the different dimensions of the arousal system to improve sleep disturbances with optimized clinical outcomes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- Classified with sleep disturbances (indications of poor sleep quality with a score >5 in Pittsburgh Sleep Quality Index)
- Education level at primary or higher, and able to communicate in Cantonese (3) No experience of mind-body exercising such as TC, Qigong, or yoga within the past 6 months
- Serious visual or hearing difficulty
- Active suicidal ideation or self-harm behaviors
- Cognitive impairment (a score <26 in the Montreal Cognitive Assessment)
- Comorbid diagnoses such as mental disorders, organic brain syndrome, or intellectual disabilities
- Cardiac pacemaker, implanted medication pump, the intracranial implant (e.g., aneurism clips, shunts, stimulators, cochlear implants, or electrodes), or any other metal object within or near the head
- Receiving other treatments or participating in other clinical trials during the same period
- Current severe medical condition preventing physical exercise
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The change from baseline (T0) Insomnia Severity Index at immediately after the intervention (T1) and 3-month follow-up (T2) Baseline (T0), immediately after the intervention (T1), and 3-month follow-up (T2)
- Secondary Outcome Measures
Name Time Method The change from baseline (T0) somatic and cognitive arousal assessed by Pre-Sleep Arousal Scale at immediately after the intervention (T1) and 3-month follow-up (T2) Baseline (T0), immediately after the intervention (T1), and 3-month follow-up (T2) The change from baseline (T0) cortical arousal measured by 15 minutes eye-closed state electroencephalogram (EEG) at immediately after the intervention (T1) and 3-month follow-up (T2) Baseline (T0), immediately after the intervention (T1), and 3-month follow-up (T2) The change from baseline (T0) sleep pattern assessed by an objective measurement (wrist ActiGraph GT3X) at immediately after the intervention (T1) and 3-month follow-up (T2) Baseline (T0), immediately after the intervention (T1), and 3-month follow-up (T2) The change from baseline (T0) mood states assessed by Depression, Anxiety, and Stress Scale-21at immediately after the intervention (T1) and 3-month follow-up (T2) Baseline (T0), immediately after the intervention (T1), and 3-month follow-up (T2)
Related Research Topics
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Trial Locations
- Locations (1)
The Hong Kong Polytechinic University
🇭🇰Hong Kong, Hong Kong
The Hong Kong Polytechinic University🇭🇰Hong Kong, Hong Kong