Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411509
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2024-05-04
Brief Title:
Integration of Tai Chi and Repetitive Transcranial Magnetic Stimulation for Sleep Disturbance in Older Adults
Sponsor:
The Hong Kong Polytechnic University
Organization:
The Hong Kong Polytechnic University
Study Overview
Official Title:
An Integration of Tai Chi and rTMS for Physical and Psychological Well-being in Older Adults With Sleep Disturbance
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 15156BBCN | OTHER_GRANT | PolyU Research Centre for Chinese Medicine Innovation | None |