An interventional study of Active Low-Frequency Repetitive Transcranial Magnetic Stimulation and Matched Sham Repetitive Transcranial Magnetic Stimulation in Sleep Wake Disorders and Lung Neoplasms, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Participants will receive five active low-frequency rTMS sessions during seven perioperative calendar days in addition to standard perioperative care.
Device: Active Low-Frequency Repetitive Transcranial Magnetic Stimulation
Participants will receive five matched sham sessions during the same perioperative schedule in addition to standard perioperative care.
Device: Matched Sham Repetitive Transcranial Magnetic Stimulation
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.
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.
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.
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.
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.
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
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.
Time frame: 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.
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
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.
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
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.
Time frame: 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.
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
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.
Time frame: Baseline before randomization and postoperative day 3, 12-24 hours after the fifth stimulation session.
Change From Baseline in Frontal Relative Beta Power on 64-Channel Electroencephalography
Relative beta power will be calculated for frontal electrodes F3, Fz, and F4 as power in the 13-30 Hz band divided by power in the 1-40 Hz band. Change from baseline will be compared between treatment groups.
Time frame: Baseline before randomization and postoperative day 3, targeted at least 24 hours after the fifth stimulation session.
Incidence of Adverse Events and Serious Adverse Events
Adverse events and serious adverse events will be collected and assessed for severity and relationship to study procedures, including headache, scalp discomfort, dizziness, syncope, mood change, and seizure.
Time frame: From the first study stimulation through 30 days after the last stimulation session.
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The First Affiliated Hospital of Guangzhou Medical University