Low-Frequency rTMS for In-Hospital Sleep Disturbance After Lung Transplantation

This is an investigator‐initiated, single‐center, prospective, randomized, double‐blind,parallel‐group, sham‐controlled trial conducted in adult recipients of a first single‐ ordouble‐lung transplantation. Eligible participants will be enrolled during postoperativedays 7‐21 after clinical stabilization and must have evidence of in‐hospital sleepdisturbance, defined by a mean Richards‐Campbell Sleep Questionnaire (RCSQ) score below70 across two consecutive valid inpatient nights together with an Insomnia Severity Index(ISI) score of at least 8.Participants will be randomized 1:1 to active or sham stimulation. Active treatment willconsist of 1‐Hz repetitive transcranial magnetic stimulation over the left dorsolateralprefrontal cortex at the F3 position, delivered at 100% of the resting motor thresholdwith 1,800 pulses per session over approximately 30 minutes. One session will beadministered daily for a total of 10 sessions completed within 10‐14 days. The sham groupwill undergo matched procedures using a dedicated sham coil or validated active/shammasking module with the same target, positioning, rhythm, sound, duration, andinteraction procedures but without intended therapeutic cortical stimulation.Participants and outcome assessors will remain blinded to treatment allocation. Clinicalstudy personnel and statistical personnel will also remain blinded as specified in theprotocol; stimulation operators cannot be blinded because of device‐operationrequirements but will not participate in recruitment, outcome assessment, data entry, orstatistical analysis.The primary outcome is the participant‐level mean RCSQ total score obtained on themornings after the nights following stimulation sessions 8, 9, and 10. The RCSQ rangesfrom 0 to 100, with higher scores indicating better sleep. The primary analysis willcompare active and sham groups using an ANCOVA/linear‐regression model adjusted forbaseline RCSQ and prespecified randomization stratification factors.Secondary and exploratory outcomes include total sleep time measured using the LifesenseHR6 wearable device, ISI and other sleep measures, pain and opioid exposure, delirium,cognitive function, anxiety, depressive symptoms, fatigue, health‐related quality oflife, hospital and transplant‐related outcomes, treatment feasibility, and adverseevents. Resting‐state 64‐channel EEG and a prespecified TMS‐EEG mechanistic substudy willexplore changes in spectral power, alpha peak frequency, functional connectivity, networktopology, and TMS‐evoked cortical responses.All participants will continue to receive standard post‐transplant clinical care andstandardized inpatient sleep‐support measures. Necessary clinical treatment will takepriority over study procedures, and the study intervention will not be used to delaytreatment, rehabilitation, transfer, or discharge.