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

Sleep Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05808517
• Other study ID #: V1
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbance

Intervention

Behavioral:
• Tai Chi
Tai Chi (TC) is a traditional Chinese exercise, also known as a mind-body exercise. It is suitable as an alternative or supplementary form of routine physical exercise for older adults. TC focuses on gentle and rhythmical movements while maintaining a meditative state. Low to moderate activities have benefits to improve sleep disturbances in older adults. In addition, growing evidence widely supports meditation as a potential intervention to improve sleep disturbances through reducing repetitive negative thoughts such as worry and rumination.

Other:
• repetitive transcranial magnetic stimulation
The brain stimulation technique repetitive transcranial magnetic stimulation (rTMS) provides the opportunity to non-invasively modulate cortical excitability. In general, low-frequency rTMS (= 1 Hz) is thought to inhibit cortical excitability.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechinic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)