Delirium - PostoperativeNCT06777342
Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery
A study testing Cognitive behavioral therapy intervention and Melatonin intervention in people with Delirium - Postoperative and Sleep Problems, run by Yan Fuxia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium - Postoperative, Sleep Problems, CABG
- What is being tested?
- Cognitive behavioral therapy intervention and Melatonin intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,281 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Scheduled for elective coronary artery bypass grafting and/or valve surgery.
- Preoperative Pittsburgh Sleep Quality Index (PSQI) score ≥ 5.
Who cannot join
- History of neurosurgery, cerebral hemorrhage, cerebral infarction, delirium, dementia, or other neurological diseases.
- History of mental illness.
- Habitual heavy drinking.
- American Society of Anesthesiologists (ASA) grade IV or above.
- Severe hepatic dysfunction (Child-Pugh Grade C) or renal dysfunction (chronic kidney disease stages 3-4).
- Contraindications to melatonin use, such as allergies to melatonin-related ingredients.
- Currently taking melatonin, melatonin receptor agonists, sleep-related medications, sedatives, antipsychotic medications, or opioids.
- Inability to communicate due to hearing or speech impairment, or refusal to provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery: a Multicenter Randomized Controlled Trial
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.
- Conditions
- Delirium - Postoperative, Sleep Problems, CABG, Valve Surgery
- Being tested
- Cognitive behavioral therapy intervention, Melatonin intervention, Placebo intervention
- Medical subject headings
- Emergence Delirium, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy interventionBehavioural
The cognitive behavioral intervention provides sleep-related education 7-14 days before surgery. The educational content should include the following aspects: 1) Establish a consistent bedtime and wake-up time, recommending a sleep schedule from 22:00 to 07:00, and avoid prolonged daytime naps; 2) Optimize the sleep environment by ensuring a quiet setting, turning off lights, and refraining from using mobile phones, computers, and other electronic devices 30 minutes before bedtime; 3) Manage diet by avoiding caffeinated foods such as chocolate, tea, and cola; 4) Engage in appropriate daytime activities as permitted by the patient's condition.
Melatonin interventionDietary supplement
Patients in the melatonin intervention group are required to take an oral melatonin of 5 mg at 30-60 minutes before sleep (administered at 21:00) nightly for 7 to 14 days before surgery. The melatonin was provided by Kangenbei Pharmaceutical Co., LTD. (Hangzhou, Zhejiang, China).
Placebo interventionOther
Patients in the placebo group need to take oral placebos of 5 mg at 30-60 minutes (administered at 21:00) before sleep, nightly, for 7 to 14 days before surgery. The placebo is provided by Guangzhou Boji Biomedical Science Park Co., LTD. (Guangzhou, Guangdong, China).
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Not described Receives: Other: Placebo intervention |
| Placebo and cognitive behavioral therapy intervention group | Experimental | Not described Receives: Behavioral: Cognitive behavioral therapy intervention; Other: Placebo intervention |
| Melatonin and cognitive behavioral therapy intervention group | Experimental | Not described Receives: Behavioral: Cognitive behavioral therapy intervention; Dietary Supplement: Melatonin intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative delirium
Measured: Postoperative 7 days or before discharge
Secondary outcomes (4)
Postoperative sleep quality
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.
Measured: Postoperative 7 days or before discharge
Postoperative cognitive function
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.
Measured: The 7th day after surgery or before discharge
Duration and severity of delirium
Measured: Postoperative 7 days or before discharge
Postoperative mood and anxiety
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.
Measured: The 7th day after surgery or before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,281 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yan Fuxia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yan Fuxia, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777342
- Sponsor's protocol ID
- 2024-2417
- Status last verified
- Nov 2024
- First submitted
- 6 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06777342
- Acronym / sponsor ID
- 2024-2417
- Conditions
- Delirium - Postoperative, Sleep Problems, CABG, Valve Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,281 participants (estimated)
- Lead sponsor
- Yan FuxiaUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: Placebo intervention |
| Placebo and cognitive behavioral therapy intervention group | Experimental | Behavioral: Cognitive behavioral therapy intervention, Other: Placebo intervention |
| Melatonin and cognitive behavioral therapy intervention group | Experimental | Behavioral: Cognitive behavioral therapy intervention, Dietary Supplement: Melatonin intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Scheduled for elective coronary artery bypass grafting and/or valve surgery.
- Preoperative Pittsburgh Sleep Quality Index (PSQI) score ≥ 5.
Key exclusion criteria (8 listed)
- History of neurosurgery, cerebral hemorrhage, cerebral infarction, delirium, dementia, or other neurological diseases.
- History of mental illness.
- Habitual heavy drinking.
- American Society of Anesthesiologists (ASA) grade IV or above.
- Severe hepatic dysfunction (Child-Pugh Grade C) or renal dysfunction (chronic kidney disease stages 3-4).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapy interventionThe cognitive behavioral intervention provides sleep-related education 7-14 days before surgery. The educational content should include the following aspects: 1) Establish a consistent bedtime and wake-up time, recommending a sleep schedule from 22:00 to 07:00, and avoid prolonged daytime naps; 2) Optimize the sleep environment by ensuring a quiet setting, turning off lights, and refraining from using mobile phones, computers, and other electronic devices 30 minutes before bedtime; 3) Manage diet by avoiding caffeinated foods such as chocolate, tea, and cola; 4) Engage in appropriate daytime activities as permitted by the patient's condition. | Behavioural | Melatonin and cognitive behavioral therapy intervention group, Placebo and cognitive behavioral therapy intervention group |
| Melatonin interventionPatients in the melatonin intervention group are required to take an oral melatonin of 5 mg at 30-60 minutes before sleep (administered at 21:00) nightly for 7 to 14 days before surgery. The melatonin was provided by Kangenbei Pharmaceutical Co., LTD. (Hangzhou, Zhejiang, China). | Dietary supplement | Melatonin and cognitive behavioral therapy intervention group |
| Placebo interventionPatients in the placebo group need to take oral placebos of 5 mg at 30-60 minutes (administered at 21:00) before sleep, nightly, for 7 to 14 days before surgery. The placebo is provided by Guangzhou Boji Biomedical Science Park Co., LTD. (Guangzhou, Guangdong, China). | Other | Placebo and cognitive behavioral therapy intervention group, Placebo group |
Primary outcome
The incidence of postoperative delirium
Time frame: Postoperative 7 days or before discharge
4 secondary outcomes
Postoperative sleep quality
Time frame: Postoperative 7 days or before discharge
Postoperative cognitive function
Time frame: The 7th day after surgery or before discharge
Duration and severity of delirium
Time frame: Postoperative 7 days or before discharge
Postoperative mood and anxiety
Time frame: The 7th day after surgery or before discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy intervention and Melatonin intervention in people with Delirium - Postoperative and Sleep Problems, run by Yan Fuxia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fuxia Yan (010 88396628, yanfuxia@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative delirium (time frame: Postoperative 7 days or before discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.