RtmsNCT07106385
The Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) on Improving Sleep Quality in Adults Without Serious Mental Illness
A study testing rtms in people with Rtms and Sleep, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) on Improving Sleep Quality in Adults Without Serious Mental Illness Introduction The investigators would like to invite participants to participate in a study on the efficacy of using magnetic fields to improve sleep quality in adults with no… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- rtms
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 4 Jul 2025to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy adults
- Aged between 18-65
- Self-reported sleep complaints
Who cannot join
- Serious mental illness other than primary insomnia
- Severe neurological conditions
- Contraindications for rTMS.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Psychiatry, HKU
Hong Kong, Pok Fu Lam
Pak Wing Cheng, 85290169487, chengpsy@hku.hk
About this study
The Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) on
Improving Sleep Quality in Adults Without Serious Mental Illness
Read more
Introduction
The investigators would like to invite participants to participate in a study on the efficacy of using magnetic fields to improve sleep quality in adults with no serious mental illness.
The research leader is Dr. Cheng Pak Wing, Assistant Professor, Department of Psychiatry, Queen Mary Hospital/ HKU Li Ka Shing Faculty of Medicine.
Please read the following information carefully. If necessary, participants can discuss with relatives, friends or doctors. If anything is unclear, or if participants would like more information, please ask us. Please carefully consider whether participants are willing to participate in this research.
Research Purpose
Sleep is a fundamental component of overall health and well-being, playing a crucial role in cognitive function, emotional regulation, and physical health. However, sleep complaints are common, even among otherwise healthy adults, often leading to reduced quality of life and increased health risks. The prevalence of poor sleep quality can be attributed to a variety of factors, including stress, lifestyle habits, and environmental disturbances.
rTMS is a non-invasive brain stimulation technique that uses magnetic fields to modulate neural activity in targeted brain regions. Over the years, rTMS has shown promise in treating various mental health conditions, including depression, obsessive-compulsive disorder (OCD) and clinical insomnia.
Research Methods
Participants
Healthy adults aged 18-65 with self-reported sleep complaints.
Treatment protocol
Six sessions of rTMS using the EXOMIND™ device, administered once or twice a week.
Each session will deliver 6,300 pulses at alternating frequencies of 12, 15, and 18 Hz, with a total duration of 24 minutes and 30 seconds.
The target site would be left dorsolateral prefrontal cortex (DLPFC), determined by the most common used 5-cm rule. The procedure would be conducted in the research centre with medical staff supported.
A checklist of potential adverse effects from TMS administration will be referenced from existing literature to monitor tolerability and adverse events during each session. Blood pressure and heart rate will be recorded at the beginning and end of each session.
Assessment
Participants will be assessed at three time points: baseline (pre-intervention), post-intervention, and four weeks post-intervention.
Assessments: Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS), Patient Health Questionnaire-9 (PHQ-9), and home sleep monitoring device.
Demographics: age, gender, years of education, place of birth, marital status, number of children, financial condition, household income, family history of sleep difficulties will be collected upon study entry. Medical history in relation to mental illnesses and medications will also be assessed.
Read the detailed description
Risks of Participation
Participants may experience mild discomfort from brain stimulation treatment. A small percentage of users may experience dizziness, headache, or nausea. The side effects of brain pulse stimulation therapy are short-lived and are not known to cause any permanent damage. If participants feel unwell after completing the brain pulse stimulation treatment, please inform the staff and therapist.
Note: Patients who have had metal implants in the head, neck, or upper back, or who have had metal teeth/dental trays or pacemakers, should not receive brain stimulation.
Benefits of Participation
The investigators sincerely invite participants to participate in this study.
The valuable information participants provide will help us understand the effect of using magnetic fields to improve sleep quality in adults.
Voluntary Participation
Participation in our research is entirely voluntary and participants have the right to withdraw from research at any time. Participants' decision to participate in or withdraw from the study will not affect participants' existing treatment or services. The information participants provide will be kept strictly confidential and all information will be used for research purposes only.
Financial Costs
Participants will not be charged for the service. Study article will not be continued to be available to subjects after the study until it is commercially available.
Confidentiality of Information
Any information about participants obtained during the research process will be kept strictly confidential. Any information about participants that is released outside the hospital (e.g. in scientific literature or reports) will not have personally identifiable information about participants. Each study participant has the right to access their personal data and publicly reported study results if required, and participants' contact details will be reserved for future follow-up studies.
Personal data will be kept for 5 years after completion of study and publications to keep track on potential side effects related to the intervention. Data will be destroyed after completion of publications.
Under the laws of Hong Kong (especially the Personal Data (Privacy) Ordinance, Cap. 486), participants have the right to keep participants' personal data confidential, such as the collection of personal data in or in connection with this research, Safeguard, retain, manage, control, use (analyze or compare), transfer within or outside Hong Kong, non-disclosure, erasure and/or deal within any way. If participants have any questions, participants can consult the Office of the Privacy Commissioner for Personal Data or call its office (telephone number: 2827 2827) to properly supervise or monitor the protection of participants' personal data so that participants are fully aware and aware of ensuring compliance with the law to protect private data meaning.
By agreeing to participate in this study, participants expressly authorize:
To oversee this study, authorize the principal investigator and his research team and the Institutional Review Board of the University of Hong Kong/ Hospital Authority Hong Kong West Cluster to obtain, use and retain participants in the manner specified in this study and this informed consent, and
Authorize relevant government agencies (such as the Hong Kong Department of Health) to obtain participants' personal data to check and verify the integrity of the research data and assess the consistency of the research agreement with the relevant requirements.
Enquiries
This study has been reviewed and approved by the Institutional Review Board of the University of Hong Kong/ Hospital Authority Hong Kong West Cluster. If participants are willing to participate in the research, please sign the enclosed informed consent form and keep this fact sheet for reference.
The study was coordinated by Dr. Cheng Pak Wing, Assistant Professor, Department of Psychiatry, Faculty of Medicine, The University of Hong Kong.
For enquiries, please contact our Research Assistant at 9016 9487, or Institutional Review Board of the University of Hong Kong/ Hospital Authority Hong Kong West Cluster at 2255 4086.
- Being tested
- rtms
- Keywords
- rtms, sleep, health adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rtmsDevice
Participants will undergo a treatment protocol involving six sessions of rTMS using the EXOMIND™ device, administered once or twice a week. Each session will deliver 6,300 pulses at alternating frequencies of 12, 15, and 18 Hz, with a total duration of 24 minutes and 30 seconds. The target site would be left dorsolateral prefrontal cortex (DLPFC), determined by the most common used 5-cm rule. The procedure would be conducted in our research centre with medical staff supported.
| Study group | Role | What they receive |
|---|---|---|
| healthy adults | Experimental | Not described Receives: Device: rtms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
Using Pittsburgh Sleep Quality Index (PSQI) to measure subjective sleep quality
In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week immediately after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention
Secondary outcomes (3)
Perceived Stress Scale (PSS)
Using perceived stress scale (PSS) to evaluate perceived stress levels.
First, reverse the scores for questions 4, 5, 7, and 8. On these 4 questions, change the scores like this: 0 = 4, 1 = 3, 2 = 2, 3 = 1, 4 = 0.
- Now add up the scores for each item to get a total. The total score is ___________.
- Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
- Scores ranging from 0-13 would be considered low stress.
- Scores ranging from 14-26 would be considered moderate stress.
- Scores ranging from 27-40 would be considered high perceived stress
Measured: Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week immediately after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention
Patient Health Questionnaire-9 (PHQ-9)
Using Patient Health Questionnaire-9 (PHQ-9) to assess depressive symptoms
Scoring: add up all checked boxes on PHQ-9 (For every 3 Not at all = 0; Several days = 1; More than half the days = 2; Nearly every day = 3)
Interpretation of Total Score: Total Score Depression Severity 1-4: Minimal depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20-27: Severe depression
Measured: Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week immediately after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention
Sleep time and stages
Using sleep watch to measure total sleep time and duration of each sleep stage (in minutes).
Participants are required to wear a watch when they sleep to monitor their sleep time and duration of each sleep stage. This is to provide an objective data in pre- and post intervention changes.
Measured: Baseline: 7 consecutive nights before the rTMS intervention starts Post-intervention: 7 consecutive nights after the last session rTMS intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start4 Jul 2025
- Primary completion27 Jun 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for RtmsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Cheng Pak Wing, Calvin, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106385
- Sponsor's protocol ID
- UW 25-281
- Status last verified
- Aug 2025
- First submitted
- 21 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protecting participants data
Publications
Voineskos D, Blumberger DM, Rogasch NC, Zomorrodi R, Farzan F, Foussias G, Rajji TK, Daskalakis ZJ. Neurophysiological effects of repetitive transcranial magnetic stimulation (rTMS) in treatment resistant depression. Clin Neurophysiol. 2021 Sep;132(9):2306-2316. doi: 10.1016/j.clinph.2021.05.008. Epub 2021 Jun 1.
PubMed 34167891Sabe M, Hyde J, Cramer C, Eberhard A, Crippa A, Brunoni AR, Aleman A, Kaiser S, Baldwin DS, Garner M, Sentissi O, Fiedorowicz JG, Brandt V, Cortese S, Solmi M. Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation Across Mental Disorders: A Systematic Review and Dose-Response Meta-Analysis. JAMA Netw Open. 2024 May 1;7(5):e2412616. doi: 10.1001/jamanetworkopen.2024.12616.
PubMed 38776083Liang K, Li H, Bu X, Li X, Cao L, Liu J, Gao Y, Li B, Qiu C, Bao W, Zhang S, Hu X, Xing H, Gong Q, Huang X. Efficacy and tolerability of repetitive transcranial magnetic stimulation for the treatment of obsessive-compulsive disorder in adults: a systematic review and network meta-analysis. Transl Psychiatry. 2021 May 28;11(1):332. doi: 10.1038/s41398-021-01453-0.
PubMed 34050130Zhu L, Dang G, Wu W, Zhou J, Shi X, Su X, Ren H, Pei Z, Lan X, Lian C, Xie P, Guo Y. Functional connectivity changes are correlated with sleep improvement in chronic insomnia patients after rTMS treatment. Front Neurosci. 2023 Apr 17;17:1135995. doi: 10.3389/fnins.2023.1135995. eCollection 2023.
PubMed 37139515Ma H, Lin J, He J, Lo DHT, Tsang HWH. Effectiveness of TES and rTMS for the Treatment of Insomnia: Meta-Analysis and Meta-Regression of Randomized Sham-Controlled Trials. Front Psychiatry. 2021 Oct 22;12:744475. doi: 10.3389/fpsyt.2021.744475. eCollection 2021.
PubMed 34744835Sun N, He Y, Wang Z, Zou W, Liu X. The effect of repetitive transcranial magnetic stimulation for insomnia: a systematic review and meta-analysis. Sleep Med. 2021 Jan;77:226-237. doi: 10.1016/j.sleep.2020.05.020. Epub 2020 May 22.
PubMed 32830052
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) on Improving Sleep Quality in Adults Without Serious Mental Illness
- ClinicalTrials.gov ID
- NCT07106385
- Acronym / sponsor ID
- UW 25-281
- Keywords
- rtms, sleep, health adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 4 Jul 2025 (actual)
- Primary completion
- 27 Jun 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 6 Aug 2025 (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.
The Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) on
Improving Sleep Quality in Adults Without Serious Mental Illness
Introduction
The investigators would like to invite participants to participate in a study on the efficacy of using magnetic fields to improve sleep quality in adults with no serious mental illness.
The research leader is Dr. Cheng Pak Wing, Assistant Professor, Department of Psychiatry, Queen Mary Hospital/ HKU Li Ka Shing Faculty of Medicine.
Please read the following information carefully. If necessary, participants can discuss with relatives, friends or doctors. If anything is unclear, or if participants would like more information, please ask us. Please carefully consider whether participants are willing to participate in this research.
Research Purpose
Sleep is a fundamental component of overall health and well-being, playing a crucial role in cognitive function, emotional regulation, and physical health. However, sleep complaints are common, even among otherwise healthy adults, often leading to reduced quality of life and increased health risks. The prevalence of poor sleep quality can be attributed to a variety of factors, including stress, lifestyle habits, and environmental disturbances.
rTMS is a non-invasive brain stimulation technique that uses magnetic fields to modulate neural activity in targeted brain regions. Over the years, rTMS has shown promise in treating various mental health conditions, including depression, obsessive-compulsive disorder (OCD) and clinical insomnia.
Research Methods
Participants
Healthy adults aged 18-65 with self-reported sleep complaints.
Treatment protocol
Six sessions of rTMS using the EXOMIND™ device, administered once or twice a week.
Each session will deliver 6,300 pulses at alternating frequencies of 12, 15, and 18 Hz, with a total duration of 24 minutes and 30 seconds.
The target site would be left dorsolateral prefrontal cortex (DLPFC), determined by the most common used 5-cm rule. The procedure would be conducted in the research centre with medical staff supported.
A checklist of potential adverse effects from TMS administration will be referenced from existing literature to monitor tolerability and adverse events during each session. Blood pressure and heart rate will be recorded at the beginning and end of each session.
Assessment
Participants will be assessed at three time points: baseline (pre-intervention), post-intervention, and four weeks post-intervention.
Assessments: Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS), Patient Health Questionnaire-9 (PHQ-9), and home sleep monitoring device.
Demographics: age, gender, years of education, place of birth, marital status, number of children, financial condition, household income, family history of sleep difficulties will be collected upon study entry. Medical history in relation to mental illnesses and medications will also be assessed.
Detailed description
Risks of Participation
Participants may experience mild discomfort from brain stimulation treatment. A small percentage of users may experience dizziness, headache, or nausea. The side effects of brain pulse stimulation therapy are short-lived and are not known to cause any permanent damage. If participants feel unwell after completing the brain pulse stimulation treatment, please inform the staff and therapist.
Note: Patients who have had metal implants in the head, neck, or upper back, or who have had metal teeth/dental trays or pacemakers, should not receive brain stimulation.
Benefits of Participation
The investigators sincerely invite participants to participate in this study.
The valuable information participants provide will help us understand the effect of using magnetic fields to improve sleep quality in adults.
Voluntary Participation
Participation in our research is entirely voluntary and participants have the right to withdraw from research at any time. Participants' decision to participate in or withdraw from the study will not affect participants' existing treatment or services. The information participants provide will be kept strictly confidential and all information will be used for research purposes only.
Financial Costs
Participants will not be charged for the service. Study article will not be continued to be available to subjects after the study until it is commercially available.
Confidentiality of Information
Any information about participants obtained during the research process will be kept strictly confidential. Any information about participants that is released outside the hospital (e.g. in scientific literature or reports) will not have personally identifiable information about participants. Each study participant has the right to access their personal data and publicly reported study results if required, and participants' contact details will be reserved for future follow-up studies.
Personal data will be kept for 5 years after completion of study and publications to keep track on potential side effects related to the intervention. Data will be destroyed after completion of publications.
Under the laws of Hong Kong (especially the Personal Data (Privacy) Ordinance, Cap. 486), participants have the right to keep participants' personal data confidential, such as the collection of personal data in or in connection with this research, Safeguard, retain, manage, control, use (analyze or compare), transfer within or outside Hong Kong, non-disclosure, erasure and/or deal within any way. If participants have any questions, participants can consult the Office of the Privacy Commissioner for Personal Data or call its office (telephone number: 2827 2827) to properly supervise or monitor the protection of participants' personal data so that participants are fully aware and aware of ensuring compliance with the law to protect private data meaning.
By agreeing to participate in this study, participants expressly authorize:
To oversee this study, authorize the principal investigator and his research team and the Institutional Review Board of the University of Hong Kong/ Hospital Authority Hong Kong West Cluster to obtain, use and retain participants in the manner specified in this study and this informed consent, and
Authorize relevant government agencies (such as the Hong Kong Department of Health) to obtain participants' personal data to check and verify the integrity of the research data and assess the consistency of the research agreement with the relevant requirements.
Enquiries
This study has been reviewed and approved by the Institutional Review Board of the University of Hong Kong/ Hospital Authority Hong Kong West Cluster. If participants are willing to participate in the research, please sign the enclosed informed consent form and keep this fact sheet for reference.
The study was coordinated by Dr. Cheng Pak Wing, Assistant Professor, Department of Psychiatry, Faculty of Medicine, The University of Hong Kong.
For enquiries, please contact our Research Assistant at 9016 9487, or Institutional Review Board of the University of Hong Kong/ Hospital Authority Hong Kong West Cluster at 2255 4086.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy adults | Experimental | Device: rtms |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adults
- Aged between 18-65
- Self-reported sleep complaints
Key exclusion criteria (3 listed)
- Serious mental illness other than primary insomnia
- Severe neurological conditions
- Contraindications for rTMS.
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 |
|---|---|---|
| rtmsParticipants will undergo a treatment protocol involving six sessions of rTMS using the EXOMIND™ device, administered once or twice a week. Each session will deliver 6,300 pulses at alternating frequencies of 12, 15, and 18 Hz, with a total duration of 24 minutes and 30 seconds. The target site would be left dorsolateral prefrontal cortex (DLPFC), determined by the most common used 5-cm rule. The procedure would be conducted in our research centre with medical staff supported. | Device | healthy adults |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week immediately after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention
Using Pittsburgh Sleep Quality Index (PSQI) to measure subjective sleep quality In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
3 secondary outcomes
Perceived Stress Scale (PSS)
Time frame: Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week immediately after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week immediately after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention
Sleep time and stages
Time frame: Baseline: 7 consecutive nights before the rTMS intervention starts Post-intervention: 7 consecutive nights after the last session rTMS intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Background: PubMed 34167891Voineskos D, Blumberger DM, Rogasch NC, Zomorrodi R, Farzan F, Foussias G, Rajji TK, Daskalakis ZJ. Neurophysiological effects of repetitive transcranial magnetic stimulation (rTMS) in treatment resistant depression. Clin Neurophysiol. 2021 Sep;132(9):2306-2316. doi: 10.1016/j.clinph.2021.05.008. Epub 2021 Jun 1.
- Background: PubMed 38776083Sabe M, Hyde J, Cramer C, Eberhard A, Crippa A, Brunoni AR, Aleman A, Kaiser S, Baldwin DS, Garner M, Sentissi O, Fiedorowicz JG, Brandt V, Cortese S, Solmi M. Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation Across Mental Disorders: A Systematic Review and Dose-Response Meta-Analysis. JAMA Netw Open. 2024 May 1;7(5):e2412616. doi: 10.1001/jamanetworkopen.2024.12616.
- Background: PubMed 34050130Liang K, Li H, Bu X, Li X, Cao L, Liu J, Gao Y, Li B, Qiu C, Bao W, Zhang S, Hu X, Xing H, Gong Q, Huang X. Efficacy and tolerability of repetitive transcranial magnetic stimulation for the treatment of obsessive-compulsive disorder in adults: a systematic review and network meta-analysis. Transl Psychiatry. 2021 May 28;11(1):332. doi: 10.1038/s41398-021-01453-0.
- Background: PubMed 37139515Zhu L, Dang G, Wu W, Zhou J, Shi X, Su X, Ren H, Pei Z, Lan X, Lian C, Xie P, Guo Y. Functional connectivity changes are correlated with sleep improvement in chronic insomnia patients after rTMS treatment. Front Neurosci. 2023 Apr 17;17:1135995. doi: 10.3389/fnins.2023.1135995. eCollection 2023.
- Background: PubMed 34744835Ma H, Lin J, He J, Lo DHT, Tsang HWH. Effectiveness of TES and rTMS for the Treatment of Insomnia: Meta-Analysis and Meta-Regression of Randomized Sham-Controlled Trials. Front Psychiatry. 2021 Oct 22;12:744475. doi: 10.3389/fpsyt.2021.744475. eCollection 2021.
- Background: PubMed 32830052Sun N, He Y, Wang Z, Zou W, Liu X. The effect of repetitive transcranial magnetic stimulation for insomnia: a systematic review and meta-analysis. Sleep Med. 2021 Jan;77:226-237. doi: 10.1016/j.sleep.2020.05.020. Epub 2020 May 22.
- Individual participant dataSharing planned: No. Protecting participants data
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rtms in people with Rtms and Sleep, run by The University of Hong Kong 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 Aug 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pak Wing Cheng (85290169487, chengpsy@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) (time frame: Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week immediately after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07106385, which also lists 6 linked publications.
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 11 Aug 2025.