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NCT07796451
Perioperative Low-Frequency rTMS for Sleep After Thoracoscopic Lung Resection
Conditions: Sleep Wake Disorders, Lung Neoplasms
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 220
Sponsor: The First Affiliated Hospital of Guangzhou Medical University
Summary
This randomized, double-blind, sham-controlled trial will evaluate whether perioperative low-frequency repetitive transcranial magnetic stimulation (rTMS) can improve early postoperative in-hospital sleep quality in adults undergoing elective thoracoscopic lung resection for primary lung cancer.
A total of 220 participants with preoperative sleep impairment will be randomly assigned in a 1:1 ratio to active rTMS or matched sham stimulation. Active rTMS will target the left dorsolateral prefrontal cortex. Five stimulation sessions will be delivered within a 7-day perioperative window: two sessions before surgery, one session after extubation when the participant is clinically stable, and one session on each of postoperative days 1 and 2.
The primary outcome is sleep quality measured using the Richards-Campbell Sleep Questionnaire during the first three postoperative inpatient nights. The study will also evaluate wearable-device sleep measures, postoperative pain and analgesic use, recovery, safety, feasibility, and changes in brain activity measured by 64-channel electroencephalography.
Eligibility Criteria
Inclusion Criteria:
Age 18-80 years and able to understand the study and provide written informed consent.
Primary lung cancer diagnosed or suspected based on pathology and/or thoracic surgical multidisciplinary assessment, with planned elective thoracoscopic lung resection.
ASA physical status I-III, with expected awake extubation after surgery and ability to complete postoperative sleep and pain assessments.
Preoperative sleep impairment, defined as an Insomnia Severity Index (ISI) score ≥8 or a Richards-Campbell Sleep Questionnaire (RCSQ) score \
Source: ClinicalTrials.gov (NCT07796451). StuddyBuddy aggregates publicly available trial information.