NCT07796451Not yet recruiting
Low-Frequency rTMS for Sleep After Thoracoscopic Lung Resection
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
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 15 Aug 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 1 Jan 2028
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Diseases
- Lung cancer
- NCT number
- NCT07796451
What you commit to
- Study type: Interventional
- Planned participants: 220
- From 1 Oct 2026 to the primary completion date, 1 Jan 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- History of epilepsy or seizure; intracranial hemorrhage, cerebral edema, increased intracranial pressure, recent stroke, or recent traumatic brain injury judged to increase TMS risk.
- 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.
- Unstable consciousness, respiratory status, circulation, or another acute condition that prevents reliable self-report or safe study procedures.
Other
- Regular opioid treatment for chronic pain or baseline chest-wall pain numeric rating scale score ≥3.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.