Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery

Not Applicable

Not yet recruiting

• Conditions: Delirium - Postoperative; Sleep Problems; CABG; Valve Surgery

• Registration Number: NCT06777342
• Lead Sponsor: Yan Fuxia

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-10
• Last Update Submitted: 2025-01-10
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15
• Study Start: 2025-02-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1281

Inclusion Criteria

1. Age ≥ 18 years.
2. Scheduled for elective coronary artery bypass grafting and/or valve surgery.
3. Preoperative Pittsburgh Sleep Quality Index (PSQI) score ≥ 5.

Exclusion Criteria

1. History of neurosurgery, cerebral hemorrhage, cerebral infarction, delirium, dementia, or other neurological diseases.
2. History of mental illness.
3. Habitual heavy drinking.
4. American Society of Anesthesiologists (ASA) grade IV or above.
5. Severe hepatic dysfunction (Child-Pugh Grade C) or renal dysfunction (chronic kidney disease stages 3-4).
6. Contraindications to melatonin use, such as allergies to melatonin-related ingredients.
7. Currently taking melatonin, melatonin receptor agonists, sleep-related medications, sedatives, antipsychotic medications, or opioids.
8. Inability to communicate due to hearing or speech impairment, or refusal to provide informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative delirium	Postoperative 7 days or before discharge

Secondary Outcome Measures

Name	Time	Method
Postoperative sleep quality	Postoperative 7 days or before discharge	The sleep quality was evaluated using the Actigraph model wGT3X-BT and the Sleep Quality and Nighttime Restlessness Scale (SQNRS) score. Subjects wore the Actigraph wGT3X-BT activity monitor from the beginning of their hospital admission until 7 days after surgery or before discharge. The device will record parameters such as total sleep time, wake time after falling asleep, number of awakenings, average wake time, and sleep efficiency during the first 7 days after surgery or before discharge to assess the subjects' sleep quality. Additionally, the SQNRS score was used to evaluate patients' subjective sleep quality during the same period. The SQNRS score ranges from 0 to 10, with higher scores indicating better sleep quality.
Postoperative cognitive function	The 7th day after surgery or before discharge	The Montreal Cognitive Assessment (MoCA) will be administered to evaluate the cognitive function of the patients 7 days after surgery or before discharge. The MoCA has a total score of 30 points, with a score above 26 indicating normal cognitive function.
Duration and severity of delirium	Postoperative 7 days or before discharge
Postoperative mood and anxiety	The 7th day after surgery or before discharge	The Hospital Anxiety and Depression Scale (HADS) will be utilized to evaluate the mood and anxiety levels of the patients during the first 7 days after surgery or before discharge. The HADS scale comprises two subscales, totalling 14 items: 7 items assess anxiety, and the other 7 assess depression. Each item is scored on a scale of 0 to 3, with each subscale totalling up to 21 points. Interpretation of the scores is as follows: 0-7 indicates a normal state, 8-10 suggests mild anxiety/depression, 11-14 indicates moderate anxiety/depression, and 15-21 suggests severe anxiety/depression.