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NCT07796425
Low-Frequency rTMS for In-Hospital Sleep Disturbance After Lung Transplantation
Conditions: Sleep Wake Disorders, Lung Transplantation
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 152
Sponsor: The First Affiliated Hospital of Guangzhou Medical University
Summary
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.
Eligibility Criteria
Inclusion Criteria:
Age 18-70 years and able to provide independent written informed consent. First single- or double-lung transplantation. Postoperative day 7-21 at randomization; extubated for at least 48 hours, off ECMO, and off vasoactive medications for at least 24 hours.
Resting SpO2 ≥92% with stable oxygen requirements and able to complete study procedures in a seated or semi-recumbent position.
Negative CAM/CAM-ICU assessment during the preceding 24 hours, with clear consciousness and ability to complete sleep and cognitive assessments.
Stable trends in blood pressure, blood glucose, serum sodium, serum magnesium, and renal function; immunosuppressant concentrations considered acceptable by the transplant team.
Mean RCSQ score \
Source: ClinicalTrials.gov (NCT07796425). StuddyBuddy aggregates publicly available trial information.