Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing … (NCT06777342) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery
1,281 participantsStarted 2025-02-01
Plain-language summary
This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in adult patients undergoing cardiac surgery. The study will include adult patients undergoing coronary artery bypass grafting and/or valve surgery with concomitant sleep disorders, as assessed by the Pittsburgh Sleep Quality Index. All participants will be randomly assigned to placebo, placebo + cognitive behavioral therapy, and melatonin + cognitive behavioral therapy in a 1:1:1 ratio. The primary outcome is the incidence of postoperative delirium within 7 days after surgery or before discharge, and secondary outcomes include postoperative cognitive function, sleep quality, and severity and duration of delirium. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.
Who can participate
Age range18 Years
SexALL
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