Clinical trial NCT05808517: An Integration of Tai Chi and Repetitive Transcranial Magnetic Stimulation for Sleep Disturbance in Older Adults
Official title: An Integration of Tai Chi (TC) and Repetitive Transcranial Magnetic Stimulation (rTMS) for Sleep Disturbance in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 38
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Classified with sleep disturbances (indications of poor sleep quality with a score \>5 in Pittsburgh Sleep Quality Index)
2. 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

Exclusion Criteria:

1. Serious visual or hearing difficulty
2. Active suicidal ideation or self-harm behaviors
3. Cognitive impairment (a score \<26 in the Montreal Cognitive Assessment)
4. Comorbid diagnoses such as mental disorders, organic brain syndrome, or intellectual disabilities
5. 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
6. Receiving other treatments or participating in other clinical trials during the same period
7. Current severe medical condition preventing physical exercise

Primary outcomes:
measure: The change from baseline (T0) Insomnia Severity Index at immediately after the intervention (T1) and 3-month follow-up (T2)
timeFrame: Baseline (T0), immediately after the intervention (T1), and 3-month follow-up (T2)
Secondary outcomes:
measure: 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)
timeFrame: Baseline (T0), immediately after the intervention (T1), and 3-month follow-up (T2)
measure: 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)
timeFrame: Baseline (T0), immediately after the intervention (T1), and 3-month follow-up (T2)
measure: 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)
timeFrame: Baseline (T0), immediately after the intervention (T1), and 3-month follow-up (T2)
measure: 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)
timeFrame: Baseline (T0), immediately after the intervention (T1), and 3-month follow-up (T2)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechinic University
Study officials:
References: