Sleep DisturbanceNCT06411509
Integration of Tai Chi and Repetitive Transcranial Magnetic Stimulation for Sleep Disturbance in Older Adults
A study testing TC plus active rTMS, TC-alone and Low intensity physical exercise in people with Sleep Disturbance and Interaction, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance, Interaction
- What is being tested?
- TC plus active rTMS, TC-alone and Low intensity physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2023to 28 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of at least 60 years
- 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
- 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
- Provide written informed consent
Who cannot join
- Cognitive impairment as determined by the Montreal Cognitive Assessment scored less than 22
- Major confounding conditions known to induce sleep perturbations, such as psychiatric disorders or chronic pain disorder
- History of head injury or epilepsy, intracranial implant, cardiac pacemaker, or any other contraindication to rTMS
- Obvious physical disability that precluded participant in the interventions
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Hong Kong Polytechnic University, Department of Rehabilitation Sciences
Kowloon
About this study
Official title: An Integration of Tai Chi and rTMS for Physical and Psychological Well-being in Older Adults With Sleep Disturbance
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.
- Conditions
- Sleep Disturbance, Interaction
- Being tested
- TC plus active rTMS, Tai Chi plus sham rTMS, TC-alone, Low intensity physical exercise
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TC plus active rTMSOther
The rTMS intervention is performed using a MagPro X100 by MagVenture with a water-cooled figure-of-eight coil. Before the treatment session, the resting motor threshold of the left abductor pollicis brevis is determined. The rMT is defined as the minimum intensity which produces five motor evoked potential responses of at least 50 μV in 10 trials at rest. A protocol of 1 Hz rTMS at 80% of RMT is applied over the frontal area of the right DLPFC. The coil position is localized using a frameless stereotactic neuronavigation system (TMS-Navigator, Localite GmbH, Bonn, Germany). Participants receive only three sessions of TC per week without rTMS during in the week 1 and 2, and the TC potocol is same as the TC-alone group. Participants receive daily rTMS (30 minutes) for 5 days a week combined with three sessions of TC in the last 2 weeks. Active rTMS deliveres at 1 Hz for 30 min (1800 pulses per session) with the intensity of 80% rMT.
Tai Chi plus sham rTMSOther
Sham rTMS is administrated the same procedures as the active rTMS but with low intensity of 20% rMT to elicit similar skin sensations and sounds. The TC protocol in this group is the same as the TC-alone group.
TC-aloneBehavioural
Participants in the TC-alone group attend a simplified Yang style 8-Form Easy TC training program in a group format. Each session lasts for 60 minutes and are conducted three times per week over a period of four weeks. In the first session, the certified TC instructor explains the exercise theory and procedures. The remaining sessions includes 5 to 10 minutes warm-up and a review of TC principles, 45 minutes meditative movements, and 5 to 10 minutes cool-down
Low intensity physical exerciseBehavioural
To achieve the same exercise volume with TC-alone group, participants in the low-intensity physical exercise control group attend a four-week exercise training in group format. Exercise sessions are 60 minutes with three times per week. Each exercise session consists of 5 to 10 minutes warm-up, 45 minutes of aerobic training, and a 5 to 10 minutes cool-down.
| Study group | Role | What they receive |
|---|---|---|
| TC plus active rTMS | Experimental | Not described Receives: Other: TC plus active rTMS |
| TC plus sham rTMS | Sham comparator | Not described Receives: Other: Tai Chi plus sham rTMS |
| TC-alone | Experimental | Not described Receives: Behavioral: TC-alone |
| Low-intensity physical exercise | Active comparator | Not described Receives: Behavioral: Low intensity physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity
Measured by Insomnia Severity Index, it's a 7-item questionnaire assessing insomnia severity over the past two weeks. Items scored 0 to 4 and total score range is from 0 to 28. Total score of 7 or less indicate no clinically significant insomnia, 8 to 14 indicate subthreshold insomnia, and 15 or greater indicate moderate to severe insomnia.
Measured: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
Secondary outcomes (7)
Actigraphy-assessed sleep parameters
Collected from a wrist ActiGraph wGT3X-BT on the nondominant hand for 7 consecutive days.
Measured: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
Self-reported sleep parameters
Derived from a consensus sleep diary for 7 days
Measured: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
Daytime sleepiness
Evaluated by the Epworth sleepiness scale (ESS). The ESS is used to rate the possibility to doze off or fall asleep. Items scored 0 to 3 and the sum ranges from 0 to 24. The total score exceeds 10 suggests signifies pathological sleepiness, and higher values reflects greater severity.
Measured: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
Emotional states
Measured by Depression, Anxiety, and Stress Scale-21 Items. Each subscale has seven items that are scored on a 4-point Likert scale (0=not at all to 3=most of the time). More severe symptoms are indicated by higher scores.
Measured: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
Mental function and physical function
The self-reported quality of life is measured by the Short Form 36-item Health Survey (SF-36) (Brazier et al. 1992). In the SF-36, the data are presented as physical component score (PCS) and mental component score (MCS). Each domain is valued from 0 to 100, with higher score denoting better health status.
Measured: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
Somatic arousal and cognitive arousal
Somatic arousal and cognitive arousal are assessed by the the Pre-Sleep Arousal Scale (PSAS). The PSAS is a 16-item self-reported questionnaire that assesses the state of arousal when falling asleep and is composed of somatic and cognitive arousal subscales with eight items in each. The somatic subscale (PSAS somatic) contains items addressing physical arousal such as racing heart, muscle tension, and rapid breathing. The cognitive subscale (PSAS cognitive) contains items on the worry about falling asleep, being mentally alert at bedtime, and the inability to shut off one's thoughts. Each subscale item is scored on a scale from 1 (not at all) to 5 (extremely). Total scores for each of the subscales can range from 8 to 40, with higher scores associated with greater arousal.
Measured: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
Cortical arousal
EEG data are collected using the DSI-24 wearable EEG device for 5 minutes in the resting state with eyes closed. Spectral power analysis and functional connectivity analysis will be conducted. Participants with lower cortical arousal shows a decrease in beta- and gamma-band power during the wakefulness eye-closed resting state. In addition, decreased connectivity in the default mode network and increased connectivity in fronto-parietal network is also suggested the improvements of cortical arousal.
Measured: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start1 Mar 2023
- Primary completion28 Apr 2024
- Study completion28 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TSANG Hector Wing-Hong, The Hong Kong Polytechnic University
- Investigators
- Hector Tsang, Professor, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411509
- Sponsor's protocol ID
- V2024-TMS
- Other IDs
- 1.51.56.BBCN
- Status last verified
- May 2024
- First submitted
- 4 May 2024
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integration of Tai Chi and rTMS for Physical and Psychological Well-being in Older Adults With Sleep Disturbance
- ClinicalTrials.gov ID
- NCT06411509
- Acronym / sponsor ID
- V2024-TMS
- Conditions
- Sleep Disturbance, Interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Apr 2024 (actual)
- Study completion
- 28 Apr 2024 (actual)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TC plus active rTMS | Experimental | Other: TC plus active rTMS |
| TC plus sham rTMS | Sham comparator | Other: Tai Chi plus sham rTMS |
| TC-alone | Experimental | Behavioral: TC-alone |
| Low-intensity physical exercise | Active comparator | Behavioral: Low intensity physical exercise |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of at least 60 years
- 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
- 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
- Provide written informed consent
Key exclusion criteria (4 listed)
- Cognitive impairment as determined by the Montreal Cognitive Assessment scored less than 22
- Major confounding conditions known to induce sleep perturbations, such as psychiatric disorders or chronic pain disorder
- History of head injury or epilepsy, intracranial implant, cardiac pacemaker, or any other contraindication to rTMS
- Obvious physical disability that precluded participant in the interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TC plus active rTMSThe rTMS intervention is performed using a MagPro X100 by MagVenture with a water-cooled figure-of-eight coil. Before the treatment session, the resting motor threshold of the left abductor pollicis brevis is determined. The rMT is defined as the minimum intensity which produces five motor evoked potential responses of at least 50 μV in 10 trials at rest. A protocol of 1 Hz rTMS at 80% of RMT is applied over the frontal area of the right DLPFC. The coil position is localized using a frameless stereotactic neuronavigation system (TMS-Navigator, Localite GmbH, Bonn, Germany). Participants receive only three sessions of TC per week without rTMS during in the week 1 and 2, and the TC potocol is same as the TC-alone group. Participants receive daily rTMS (30 minutes) for 5 days a week combined with three sessions of TC in the last 2 weeks. Active rTMS deliveres at 1 Hz for 30 min (1800 pulses per session) with the intensity of 80% rMT. | Other | TC plus active rTMS |
| Tai Chi plus sham rTMSSham rTMS is administrated the same procedures as the active rTMS but with low intensity of 20% rMT to elicit similar skin sensations and sounds. The TC protocol in this group is the same as the TC-alone group. | Other | TC plus sham rTMS |
| TC-aloneParticipants in the TC-alone group attend a simplified Yang style 8-Form Easy TC training program in a group format. Each session lasts for 60 minutes and are conducted three times per week over a period of four weeks. In the first session, the certified TC instructor explains the exercise theory and procedures. The remaining sessions includes 5 to 10 minutes warm-up and a review of TC principles, 45 minutes meditative movements, and 5 to 10 minutes cool-down | Behavioural | TC-alone |
| Low intensity physical exerciseTo achieve the same exercise volume with TC-alone group, participants in the low-intensity physical exercise control group attend a four-week exercise training in group format. Exercise sessions are 60 minutes with three times per week. Each exercise session consists of 5 to 10 minutes warm-up, 45 minutes of aerobic training, and a 5 to 10 minutes cool-down. | Behavioural | Low-intensity physical exercise |
Primary outcome
Insomnia Severity
Time frame: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
Measured by Insomnia Severity Index, it's a 7-item questionnaire assessing insomnia severity over the past two weeks. Items scored 0 to 4 and total score range is from 0 to 28. Total score of 7 or less indicate no clinically significant insomnia, 8 to 14 indicate subthreshold insomnia, and 15 or greater indicate moderate to severe insomnia.
7 secondary outcomes
Actigraphy-assessed sleep parameters
Time frame: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
Self-reported sleep parameters
Time frame: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
Daytime sleepiness
Time frame: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
Emotional states
Time frame: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
Mental function and physical function
Time frame: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
Somatic arousal and cognitive arousal
Time frame: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
Cortical arousal
Time frame: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hector Tsang, Professor principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TC plus active rTMS, TC-alone and Low intensity physical exercise in people with Sleep Disturbance and Interaction, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity (time frame: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.