This randomized, double-blind, sham-controlled trial will evaluate whether low-frequency repetitive transcranial magnetic stimulation (rTMS) can improve in-hospital sleep quality in adult lung transplant recipients during early postoperative recovery.
A total of 152 participants with in-hospital sleep disturbance after first single- or double-lung transplantation 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 and will be delivered once daily for 10 sessions within 10-14 days.
The primary outcome is sleep quality measured using the Richards-Campbell Sleep Questionnaire during the nights following stimulation sessions 8, 9, and 10. The study will also evaluate wearable-device sleep measures, insomnia symptoms, pain, mood, cognitive and functional outcomes, safety, feasibility, and changes in brain activity measured by 64-channel electroencephalography.
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Active Low-Frequency Repetitive Transcranial Magnetic Stimulation
DeviceActive rTMS will be delivered over the left dorsolateral prefrontal cortex at the F3 position using a figure-of-eight coil. Stimulation parameters are 1 Hz, 100% of the resting motor threshold, and 1,800 pulses per session over approximately 30 minutes. Treatment will be administered once daily for a total of 10 sessions completed within 10-14 days during the same hospitalization. No more than one study stimulation session will be administered on the same calendar day.
Sham Repetitive Transcranial Magnetic Stimulation
DeviceSham stimulation will be administered using a dedicated sham coil or validated active/sham masking module compatible with the locked study device. The target location, participant positioning, stimulation rhythm, sound, session duration, and interaction procedures will match active rTMS, but the sham procedure will not produce the intended therapeutic cortical stimulation. Sham stimulation will be administered once daily for a total of 10 sessions within 10-14 days.
Mean Richards-Campbell Sleep Questionnaire Total Score Across the Nights Following Stimulation Sessions 8-10
The Richards-Campbell Sleep Questionnaire (RCSQ) total score is calculated as the mean of five visual analog items and ranges from 0 to 100, with higher scores indicating better sleep. The primary outcome is the participant-level mean RCSQ total score obtained on the mornings after the nights following stimulation sessions 8, 9, and 10. At least two valid RCSQ nights are required to calculate the mean. The primary analysis will adjust for the mean RCSQ score from two consecutive valid baseline inpatient nights.
Mean Total Sleep Time Measured by Lifesense HR6 Across the Nights Following Stimulation Sessions 8-10
Total sleep time (TST), measured in minutes by the Lifesense HR6 wearable device, will be averaged across valid device nights corresponding to the nights following stimulation sessions 8, 9, and 10. At least two valid device nights are required to calculate the participant-level mean TST.
Generalized Anxiety Disorder-7 Score
Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale, with total scores ranging from 0 to 21 and higher scores indicating greater symptom severity.
Patient Health Questionnaire-9 Score
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), with total scores ranging from 0 to 27 and higher scores indicating greater symptom severity.
EQ-5D-5L Health-Related Quality of Life
Health-related quality of life will be assessed using the Simplified Chinese version of the EQ-5D-5L. The China value-set utility index and EQ visual analog scale will be reported.
Change in Prespecified EEG Frequency-Band Power
Change in prespecified 64-channel EEG frequency-band power from baseline to the post-treatment assessment will be evaluated using the predefined EEG analysis pipeline.
Change in Prespecified EEG Functional Connectivity
Change in prespecified functional connectivity derived from 64-channel EEG recordings from baseline to the post-treatment assessment will be evaluated using the predefined connectivity analysis pipeline.
Change in TMS-Evoked Cortical Response
Change in the prespecified TMS-evoked cortical response measured by TMS-EEG from baseline to the post-treatment assessment will be evaluated.
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