An Integration of Tai Chi (TC) and Repetitive Transcranial Magnetic Stimulation (rTMS) for Sleep Disturbance in Older Adults

The Hong Kong Polytechnic University1 site in 1 country38 target enrollmentJuly 1, 2022

ConditionsSleep Disturbance

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sleep Disturbance
Sponsor: The Hong Kong Polytechnic University
Enrollment: 38
Locations: 1
Primary Endpoint: The change from baseline (T0) Insomnia Severity Index at immediately after the intervention (T1) and 3-month follow-up (T2)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 1, 2022

End Date

December 31, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The Hong Kong Polytechnic University

Responsible Party

Principal Investigator

TSANG Hector Wing-Hong

Professor

The Hong Kong Polytechnic University

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Outcomes

Primary Outcomes

The change from baseline (T0) Insomnia Severity Index at immediately after the intervention (T1) and 3-month follow-up (T2)

Time Frame: Baseline (T0), immediately after the intervention (T1), and 3-month follow-up (T2)

Secondary Outcomes

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))