Sleep Wake DisordersTMS-SLEEP-VATSNCT07796451
Low-Frequency rTMS for Sleep After Thoracoscopic Lung Resection
A study testing Active Low-Frequency Repetitive Transcranial Magnetic Stimulation in people with Sleep Wake Disorders and Lung Neoplasms, run by The First Affiliated Hospital of Guangzhou Medical University.
Trial summary
This single-center randomized, double-blind, sham-controlled trial will evaluate whether low-frequency repetitive transcranial magnetic stimulation (rTMS) improves postoperative inpatient sleep in adults undergoing elective thoracoscopic lung resection for primary lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Wake Disorders, Lung Neoplasms
- What is being tested?
- Active Low-Frequency Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2028
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years and able to provide written informed consent.
- Primary lung cancer confirmed by pathology or multidisciplinary evaluation and scheduled for elective thoracoscopic lung resection, including wedge resection, segmentectomy, lobectomy, bilobectomy, or pneumonectomy.
- American Society of Anesthesiologists physical status I-III, with awake extubation and reliable self-report expected after surgery.
- Protocol-defined sleep impairment: Insomnia Severity Index score ≥8 or the most recent evaluable preoperative inpatient RCSQ total score <70.
- Baseline TMS safety screening, resting motor threshold, RCSQ, ISI, HR6 actigraphy, and 64-channel EEG can be completed before randomization and the first study stimulation.
- The clinical schedule permits two preoperative and three postoperative sessions and at least three postoperative inpatient nights without delaying necessary clinical care or discharge.
Who cannot join
- History of epilepsy or seizure; intracranial hemorrhage, cerebral edema, increased intracranial pressure, recent stroke, or recent traumatic brain injury judged to increase TMS risk.
- Ferromagnetic or electronic implants incompatible with TMS, including incompatible intracranial metal, cochlear implant, deep-brain stimulator, or other implanted electronic device near the stimulation field.
- Severe scalp infection, open wound, or other local condition preventing safe coil placement.
- Pregnancy or another condition judged by the investigator to create unacceptable risk from study procedures.
- Emergency surgery, planned open thoracotomy, planned prolonged postoperative mechanical ventilation or deep sedation, or another perioperative plan that makes the stimulation and assessment schedule infeasible.
- Regular opioid treatment for chronic pain or baseline chest-wall pain numeric rating scale score ≥3.
- Unstable consciousness, respiratory status, circulation, or another acute condition that prevents reliable self-report or safe study procedures.
About this study
Official title: Low-Frequency Repetitive Transcranial Magnetic Stimulation Combined With 64-Channel Electroencephalography for Postoperative Inpatient Sleep Disturbance in Patients Undergoing Thoracoscopic Lung Resection: A Randomized, Double-Blind, Sham-Controlled Trial
This single-center randomized, double-blind, sham-controlled trial will evaluate whether low-frequency repetitive transcranial magnetic stimulation (rTMS) improves postoperative inpatient sleep in adults undergoing elective thoracoscopic lung resection for primary lung cancer. A total of 220 participants will be assigned 1:1 to active or matched sham stimulation. Five sessions will be delivered during seven perioperative calendar days, with no more than one session per day. The primary outcome is each participant's mean Richards-Campbell Sleep Questionnaire (RCSQ) total score across postoperative inpatient nights 1-3, calculated from at least two eligible nights. Secondary outcomes include length of postoperative hospitalization, pain, quality of life, actigraphy-derived sleep, anxiety, depression, electroencephalographic measures, and safety.
Read the detailed description
Participants will be randomized in a 1:1 ratio to active low-frequency rTMS or matched sham stimulation using variable block sizes of 4 and 6. Randomization will be stratified by planned resection extent (wedge or segmental resection versus lobectomy or greater resection) and baseline Insomnia Severity Index (ISI) category (<15 versus ≥15). Allocation will be concealed with sequentially numbered, opaque, sealed envelopes or an equivalent controlled allocation system.
Active treatment will target the left dorsolateral prefrontal cortex at F3 using a figure-of-eight coil, 1 Hz stimulation, 100% of resting motor threshold, and 1,800 pulses over approximately 30 minutes per session. The five planned sessions are preoperative day -2, preoperative day -1, 2-6 hours after awake extubation when clinically stable, postoperative day 1, and postoperative day 2. No more than one session may be performed on any calendar day. The sham arm will use a dedicated compatible sham coil or coded active/sham module with matched procedures and no intended cortical stimulation.
The primary analysis will compare the participant-level mean RCSQ total score across postoperative inpatient nights 1-3. A nightly score is eligible when at least 4 of 5 RCSQ visual-analogue items are completed. The participant-level value will be the arithmetic mean of at least two eligible nightly scores; thus, it may be based on two or three nights. The model will adjust for the most recent evaluable pre-randomization inpatient RCSQ score, randomization strata, and regular hypnotic use.
The planned enrollment is 220 participants (110 per group). The protocol assumes a between-group RCSQ difference of 10 points, a common standard deviation of 20 points, a two-sided alpha of 0.05, and 90% power, requiring 86 evaluable participants per group before a 20% allowance for non-evaluable primary outcomes.
- Conditions
- Sleep Wake Disorders, Lung Neoplasms
- Being tested
- Active Low-Frequency Repetitive Transcranial Magnetic Stimulation, Matched Sham Repetitive Transcranial Magnetic Stimulation
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Postoperative Sleep Disturbance, Thoracoscopic Lung Resection, Perioperative Care, Dorsolateral Prefrontal Cortex
- Medical subject headings
- Sleep Wake Disorders, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Low-Frequency Repetitive Transcranial Magnetic StimulationDevice
Stimulation will target the left dorsolateral prefrontal cortex at F3 with a figure-of-eight coil. Each session will use 1 Hz stimulation at 100% of resting motor threshold, 1,800 pulses, and a duration of approximately 30 minutes. Sessions are planned for preoperative day -2, preoperative day -1, 2-6 hours after awake extubation when clinically stable, postoperative day 1, and postoperative day 2. A maximum of one session is allowed per calendar day.
Matched Sham Repetitive Transcranial Magnetic StimulationDevice
A dedicated compatible sham coil or coded active/sham module will be used. Target, participant posture, coil placement procedure, acoustic cues, session duration, staff interaction, and visit schedule will match the active arm, but no intentional cortical stimulation will be delivered. The standard active coil rotated 90 degrees will not be used as the sham method. A maximum of one session is allowed per calendar day.
| Study group | Role | What they receive |
|---|---|---|
| Active Low-Frequency rTMS | Experimental | Participants will receive five active low-frequency rTMS sessions during seven perioperative calendar days in addition to standard perioperative care. Receives: Device: Active Low-Frequency Repetitive Transcranial Magnetic Stimulation |
| Matched Sham rTMS | Sham comparator | Participants will receive five matched sham sessions during the same perioperative schedule in addition to standard perioperative care. Receives: Device: Matched Sham Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Richards-Campbell Sleep Questionnaire Total Score Across Postoperative Inpatient Nights 1-3
The RCSQ contains five visual-analogue items scored from 0 to 100, with higher scores indicating better perceived sleep. A nightly total score is the mean of completed items and is eligible when at least 4 of 5 items are completed. For each participant, the outcome is the arithmetic mean of at least two eligible nightly total scores collected on postoperative inpatient nights 1-3; the mean may therefore use two or three nights. The primary model will adjust for the most recent evaluable pre-randomization inpatient RCSQ score, randomization strata, and regular hypnotic use.
Measured: Postoperative inpatient nights 1-3; each questionnaire is completed the following morning, preferably 07:00-10:00 and no later than 12:00 if delayed by clinical care.
Secondary outcomes (7)
Time From End of Surgery to Live Discharge From the Continuous Acute-Care Hospitalization
Time in hours or days from the recorded end of surgery to live discharge from the same continuous acute-care hospitalization. Death before discharge will be handled as a competing event according to the statistical analysis plan.
Measured: From end of surgery until live discharge, in-hospital death, or 90 days after surgery, whichever occurs first.
Mean Standardized Cough Pain Numeric Rating Scale Score Across the First 3 Postoperative Mornings
Cough pain will be rated from 0 to 10, with higher scores indicating worse pain. The participant-level outcome will be the mean of at least two available standardized morning assessments during postoperative days 1-3.
Measured: Postoperative mornings 1-3.
Change From Baseline in Quality of Life, Anxiety, and Depression at Postoperative Day 30
Supportive follow-up will assess EORTC QLQ-C30 Global Health Status/Quality of Life, GAD-7, and PHQ-9 scores. Each change is follow-up minus baseline, with direction interpreted according to the corresponding scale.
Measured: Baseline and postoperative day 30 ± 7 days.
Change From Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life Score on Postoperative Day 3
The EORTC QLQ-C30 Global Health Status/Quality of Life domain is transformed to a 0-100 score, with higher scores indicating better global health and quality of life. Change is calculated as postoperative day 3 minus baseline; positive values indicate improvement.
Measured: Baseline before randomization and postoperative day 3, 12-24 hours after the fifth stimulation session.
Mean Actigraphy-Estimated Total Sleep Time Across Postoperative Inpatient Nights 1-3
Total sleep time will be estimated by HR6 actigraphy. The participant-level outcome will be the mean of at least two valid nights. The analysis will adjust for the available pre-randomization actigraphy value according to the statistical analysis plan.
Measured: Postoperative inpatient nights 1-3.
Change From Baseline in Generalized Anxiety Disorder-7 Score on Postoperative Day 3
The GAD-7 total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms. Change is postoperative day 3 minus baseline; negative values indicate improvement.
Measured: Baseline before randomization and postoperative day 3, 12-24 hours after the fifth stimulation session.
Change From Baseline in Patient Health Questionnaire-9 Score on Postoperative Day 3
The PHQ-9 total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms. Change is postoperative day 3 minus baseline; negative values indicate improvement. Responses to item 9 will trigger the protocol-defined safety assessment and referral pathway.
Measured: Baseline before randomization and postoperative day 3, 12-24 hours after the fifth stimulation session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Wake DisordersStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796451
- Sponsor's protocol ID
- TMS-SLEEP-VATS-01
- Acronym
- TMS-SLEEP-VATS
- Status last verified
- Sep 2026
- First submitted
- 15 Aug 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Frequency Repetitive Transcranial Magnetic Stimulation Combined With 64-Channel Electroencephalography for Postoperative Inpatient Sleep Disturbance in Patients Undergoing Thoracoscopic Lung Resection: A Randomized, Double-Blind, Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT07796451
- Acronym / sponsor ID
- TMS-SLEEP-VATS / TMS-SLEEP-VATS-01
- Conditions
- Sleep Wake Disorders, Lung Neoplasms
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Postoperative Sleep Disturbance, Thoracoscopic Lung Resection, Perioperative Care, Dorsolateral Prefrontal Cortex
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 1 Sep 2026 (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 single-center randomized, double-blind, sham-controlled trial will evaluate whether low-frequency repetitive transcranial magnetic stimulation (rTMS) improves postoperative inpatient sleep in adults undergoing elective thoracoscopic lung resection for primary lung cancer. A total of 220 participants will be assigned 1:1 to active or matched sham stimulation. Five sessions will be delivered during seven perioperative calendar days, with no more than one session per day. The primary outcome is each participant's mean Richards-Campbell Sleep Questionnaire (RCSQ) total score across postoperative inpatient nights 1-3, calculated from at least two eligible nights. Secondary outcomes include length of postoperative hospitalization, pain, quality of life, actigraphy-derived sleep, anxiety, depression, electroencephalographic measures, and safety.
Detailed description
Participants will be randomized in a 1:1 ratio to active low-frequency rTMS or matched sham stimulation using variable block sizes of 4 and 6. Randomization will be stratified by planned resection extent (wedge or segmental resection versus lobectomy or greater resection) and baseline Insomnia Severity Index (ISI) category (<15 versus ≥15). Allocation will be concealed with sequentially numbered, opaque, sealed envelopes or an equivalent controlled allocation system.
Active treatment will target the left dorsolateral prefrontal cortex at F3 using a figure-of-eight coil, 1 Hz stimulation, 100% of resting motor threshold, and 1,800 pulses over approximately 30 minutes per session. The five planned sessions are preoperative day -2, preoperative day -1, 2-6 hours after awake extubation when clinically stable, postoperative day 1, and postoperative day 2. No more than one session may be performed on any calendar day. The sham arm will use a dedicated compatible sham coil or coded active/sham module with matched procedures and no intended cortical stimulation.
The primary analysis will compare the participant-level mean RCSQ total score across postoperative inpatient nights 1-3. A nightly score is eligible when at least 4 of 5 RCSQ visual-analogue items are completed. The participant-level value will be the arithmetic mean of at least two eligible nightly scores; thus, it may be based on two or three nights. The model will adjust for the most recent evaluable pre-randomization inpatient RCSQ score, randomization strata, and regular hypnotic use.
The planned enrollment is 220 participants (110 per group). The protocol assumes a between-group RCSQ difference of 10 points, a common standard deviation of 20 points, a two-sided alpha of 0.05, and 90% power, requiring 86 evaluable participants per group before a 20% allowance for non-evaluable primary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Low-Frequency rTMS | Experimental | Device: Active Low-Frequency Repetitive Transcranial Magnetic StimulationParticipants will receive five active low-frequency rTMS sessions during seven perioperative calendar days in addition to standard perioperative care. |
| Matched Sham rTMS | Sham comparator | Device: Matched Sham Repetitive Transcranial Magnetic StimulationParticipants will receive five matched sham sessions during the same perioperative schedule in addition to standard perioperative care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-80 years and able to provide written informed consent.
- Primary lung cancer confirmed by pathology or multidisciplinary evaluation and scheduled for elective thoracoscopic lung resection, including wedge resection, segmentectomy, lobectomy, bilobectomy, or pneumonectomy.
- American Society of Anesthesiologists physical status I-III, with awake extubation and reliable self-report expected after surgery.
- Protocol-defined sleep impairment: Insomnia Severity Index score ≥8 or the most recent evaluable preoperative inpatient RCSQ total score <70.
- Baseline TMS safety screening, resting motor threshold, RCSQ, ISI, HR6 actigraphy, and 64-channel EEG can be completed before randomization and the first study stimulation.
Key exclusion criteria (7 listed)
- History of epilepsy or seizure; intracranial hemorrhage, cerebral edema, increased intracranial pressure, recent stroke, or recent traumatic brain injury judged to increase TMS risk.
- Ferromagnetic or electronic implants incompatible with TMS, including incompatible intracranial metal, cochlear implant, deep-brain stimulator, or other implanted electronic device near the stimulation field.
- Severe scalp infection, open wound, or other local condition preventing safe coil placement.
- Pregnancy or another condition judged by the investigator to create unacceptable risk from study procedures.
- Emergency surgery, planned open thoracotomy, planned prolonged postoperative mechanical ventilation or deep sedation, or another perioperative plan that makes the stimulation and assessment schedule infeasible.
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 |
|---|---|---|
| Active Low-Frequency Repetitive Transcranial Magnetic StimulationStimulation will target the left dorsolateral prefrontal cortex at F3 with a figure-of-eight coil. Each session will use 1 Hz stimulation at 100% of resting motor threshold, 1,800 pulses, and a duration of approximately 30 minutes. Sessions are planned for preoperative day -2, preoperative day -1, 2-6 hours after awake extubation when clinically stable, postoperative day 1, and postoperative day 2. A maximum of one session is allowed per calendar day. | Device | Active Low-Frequency rTMS |
| Matched Sham Repetitive Transcranial Magnetic StimulationA dedicated compatible sham coil or coded active/sham module will be used. Target, participant posture, coil placement procedure, acoustic cues, session duration, staff interaction, and visit schedule will match the active arm, but no intentional cortical stimulation will be delivered. The standard active coil rotated 90 degrees will not be used as the sham method. A maximum of one session is allowed per calendar day. | Device | Matched Sham rTMS |
Primary outcome
Mean Richards-Campbell Sleep Questionnaire Total Score Across Postoperative Inpatient Nights 1-3
Time frame: Postoperative inpatient nights 1-3; each questionnaire is completed the following morning, preferably 07:00-10:00 and no later than 12:00 if delayed by clinical care.
The RCSQ contains five visual-analogue items scored from 0 to 100, with higher scores indicating better perceived sleep. A nightly total score is the mean of completed items and is eligible when at least 4 of 5 items are completed. For each participant, the outcome is the arithmetic mean of at least two eligible nightly total scores collected on postoperative inpatient nights 1-3; the mean may therefore use two or three nights. The primary model will adjust for the most recent evaluable pre-randomization inpatient RCSQ score, randomization strata, and regular hypnotic use.
7 secondary outcomes
Time From End of Surgery to Live Discharge From the Continuous Acute-Care Hospitalization
Time frame: From end of surgery until live discharge, in-hospital death, or 90 days after surgery, whichever occurs first.
Mean Standardized Cough Pain Numeric Rating Scale Score Across the First 3 Postoperative Mornings
Time frame: Postoperative mornings 1-3.
Change From Baseline in Quality of Life, Anxiety, and Depression at Postoperative Day 30
Time frame: Baseline and postoperative day 30 ± 7 days.
Change From Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life Score on Postoperative Day 3
Time frame: Baseline before randomization and postoperative day 3, 12-24 hours after the fifth stimulation session.
Mean Actigraphy-Estimated Total Sleep Time Across Postoperative Inpatient Nights 1-3
Time frame: Postoperative inpatient nights 1-3.
Change From Baseline in Generalized Anxiety Disorder-7 Score on Postoperative Day 3
Time frame: Baseline before randomization and postoperative day 3, 12-24 hours after the fifth stimulation session.
Change From Baseline in Patient Health Questionnaire-9 Score on Postoperative Day 3
Time frame: Baseline before randomization and postoperative day 3, 12-24 hours after the fifth stimulation session.
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 23 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Active Low-Frequency Repetitive Transcranial Magnetic Stimulation in people with Sleep Wake Disorders and Lung Neoplasms, run by The First Affiliated Hospital of Guangzhou Medical University.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
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?
Mean Richards-Campbell Sleep Questionnaire Total Score Across Postoperative Inpatient Nights 1-3 (time frame: Postoperative inpatient nights 1-3; each questionnaire is completed the following morning, preferably 07:00-10:00 and no later than 12:00 if delayed by clinical care.). 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 23 Sep 2026.