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

Study acronym: TMS-SLEEP-LTx
StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07796425
Lead Sponsor The First Affiliated Hospital of Guangzhou Medical University
Conditions
(from sponsor)		 Sleep Wake Disorders, Lung Transplantation
Related terms Sleep Wake Disorders
Enrollment 152 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov