Clinical trial NCT06411509: Integration of Tai Chi and Repetitive Transcranial Magnetic Stimulation for Sleep Disturbance in Older Adults
Official title: An Integration of Tai Chi and rTMS for Physical and Psychological Well-being in Older Adults With Sleep Disturbance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Interaction
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 152
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a novel and the first study to investigate the impacts of the integrated treatment of Tai Chi (TC) and repetitive transcranial magnetic stimulation (rTMS) on sleep disturbances and the potential mechanisms of arousal system. To validate the combination of TC and rTMS as a promising approach for managing sleep disturbance in older adults, the investigators will conduct a four-arm, parallel-group, randomized controlled trial comprising a 4-week treatment phase and a 3-month follow up period. A total of 152 eligible participants will be recruited and randomly assign to the TC plus active rTMS (38 participants), TC plus sham rTMS (38 participants), TC-alone (38 participants), and low-intensity PE (38 participants) control group within two weeks after the baseline assessment. TC plus active rTMS, TC plus sham rTMS, and TC-alone will be compared with a low-intensity PE control group on insomnia severity, various sleep parameters assessed by self-report sleep diary and ActiGraph, emotional states, and physical and mental health related quality of life. The investigators have formulated two hypotheses in this study. First, the three intervention groups, relative to participants undergoing PE, will confer greater improvement in all measured outcomes at post-intervention (T1) and three-month follow-up (T2); and second, in the double-blinded groups, the TC plus active rTMS will show greater improvement in all measured outcomes than TC plus sham rTMS at T1 and T2.


Eligibility criteria: Inclusion Criteria:

1. Age of at least 60 years
2. Active sleep disturbance as indicated by the Pittsburgh Sleep Quality Index (PSQI) score exceeding 5 and the Insomnia Severity Index (ISI) score greater than 7 at screening
3. No prior experience of mind-body exercises (i.e., TC, Qigong, or yoga, etc.) and regular moderate-intensity exercise (i.e., above three times per week and 30 minutes per session) in the past 6 months
4. Provide written informed consent

Exclusion Criteria:

1. Cognitive impairment as determined by the Montreal Cognitive Assessment scored less than 22
2. Major confounding conditions known to induce sleep perturbations, such as psychiatric disorders or chronic pain disorder
3. History of head injury or epilepsy, intracranial implant, cardiac pacemaker, or any other contraindication to rTMS
4. Obvious physical disability that precluded participant in the interventions

Primary outcomes:
measure: Insomnia Severity
timeFrame: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
Secondary outcomes:
measure: Actigraphy-assessed sleep parameters
timeFrame: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
measure: Self-reported sleep parameters
timeFrame: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
measure: Daytime sleepiness
timeFrame: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
measure: Emotional states
timeFrame: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
measure: Mental function and physical function
timeFrame: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
measure: Somatic arousal and cognitive arousal
timeFrame: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
measure: Cortical arousal
timeFrame: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: Hong Kong Polytechnic University, Department of Rehabilitation Sciences
Study officials:
affiliation: Hong Kong Polytechnic University
name: Hector Tsang, Professor
role: PRINCIPAL_INVESTIGATOR
References: