NCT06721819 The SCOPE Trial: Sleep, Cognition, and Pain Bundle vs. ERAS-cardiac for Postoperative Delirium
| NCT ID | NCT06721819 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Beth Israel Deaconess Medical Center |
| Condition | Delirium, Postoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 406 participants |
| Start Date | 2025-06-06 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 406 participants in total. It began in 2025-06-06 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Sleep disturbances, cognitive reserve, and continuing pain and inflammation are other risk factors contributing to delirium (confusion and agitation) and neurocognitive decline (in the long term) following heart surgery. Investigators aim to test a bundle of sleep optimization, cognitive exercise before surgery, and extended pain relief for 48 hours with intravenous acetaminophen combined with enhanced recovery after surgery protocols (SCOPE bundle). SCOPE will fill significant gaps in evidence by testing the value of a patient and care-provider-focused intervention that can potentially minimize POD and improve outcomes (cognitive \& physical function, sleep quality, pain, depression or anxiety, and survival) important to patients and families. The SCOPE trial will address many heart surgery outcome-related questions commonly asked by patients: What can I do to reduce my chances of developing confusion, hallucinations, or delirium after surgery? How can I best prepare before surgery to improve my long-term health and avoid disability? Are there exercises I can participate in that improve my sleep, pain, and mood after surgery? Intellectual pursuits, physical activity, and social interactions support cognitive reserve, while poor health, poor sleep hygiene, poor nutrition, and mental health disease can diminish reserve. Various interventions with different intensities and timing to augment cognitive reserve have been associated with positive outcomes on neuropsychological testing. Adaptive video gaming for as little as 10 hours leads to the maintenance of independence in activities of daily living and sustained improvements in speed of processing, attention, and working memory in older people. Likely through the increased cognitive reserve, perioperative brain exercise aims to protect against morbid cognitive recovery after surgery. Sleep is vital for memory and cognitive function. Poor sleep traits in older adults that are potentially modifiable, including short/long duration, daytime napping, and associated sleepiness, led to an almost 2-fold increase in delirium risk. Patients will complete an evidence-based course on healthy sleep habits and will complete guided exercises designed to restructure behaviors and thinking. They are encouraged to follow a set of recommendations to improve their sleep (e.g., optimal sleep duration, advice for habits such as daytime napping, maintaining a regular sleep schedule, avoiding caffeine, regular daylight exposure, dimming lights or electronics and relaxation and thought exercises for optimal sleep); many of these sleep behaviors have been strongly linked to increased risk for cognitive decline. Investigators propose that sleep optimization before AND after (an established best practice sleep bundle) surgical insult will contribute to cognitive reserve leading to decreased delirium risk and key patient-centered outcomes (postoperative sleep, pain, cognition, mood, and survival). Inadequate pain relief and opioids are both risk factors for delirium. Surgery on the chest is a significant pain source. Approximately 30-75% of patients suffer from moderate to severe pain in the postoperative period. Almost half of the patients have severe pain at rest, and three-quarters have severe pain during coughing and movement. Pain and inflammation are closely biochemically linked. Sleep, brain exercise, and adequate pain control with opioid-sparing can be additive or synergistic interventions to prevent delirium following heart surgery. Investigators propose three specific aims by conducting a 1:1 randomized controlled trial in 406 heart surgery patients 60 or older undergoing heart surgery. They will be administered perioperative sleep optimization, brain exercise training, and intravenous acetaminophen over 48 hours. A trained expert will administer the sleep and cognitive exercise protocols at least two weeks before surgery. This expert will handhold the patients for two weeks until the surgery. Thus, the gains made before surgery with better sleep quality and improved brain reserve will be sustained with postoperative pain control to lower the ongoing inflammation. Through this trial, investigators will evaluate if the SCOPE bundle can reduce 1) in-hospital delirium, 2) long-term (one, six, and twelve months) cognitive, physical, and self-care function, and 3) barriers to implementation of this bundle. Currently, no options are routinely available to patients to optimize their sleep and cognition before cardiac surgery. The proposed research is significant because it will be the first to test the bundled behavioral intervention approach (sleep optimization, brain exercise) before surgery with extended, scheduled pain management with non-opioids following surgery. The SCOPE trial will yield relevant and immediately actionable data to improve care for over 900,000 adults in the U.S. each year.
Eligibility Criteria
Inclusion Criteria: * Planned cardiac surgery \[CABG with or without valve, isolated valve surgery\] requiring median sternotomy and full CPB at least 10 days in the future. * 60 years of age. Willingness to use a provided tablet and wearable devices and commit at least 1 hour amount of time per day before surgery to complete interventions (psCBT/cognitive activity/exercise) if randomized to experimental group. Exclusion Criteria: * Pre-operative left ventricular ejection fraction (LVEF) \< than 30% Emergent procedures Isolated aortic surgery Liver dysfunction (ALT or AST \> 4 times the upper limit of local normal; all patients will have a baseline liver function test information or history and exam suggestive of jaundice or both) Known hypersensitivity to the study drugs Active (in the past year) history of alcohol abuse (≥ 5 drinks/day for men or ≥ 4 drinks/day for women) Any history of alcohol withdrawal or delirium tremens Delirium at baseline English language Limitations Physician refusal Chronic opioid use for chronic pain conditions with tolerance (total dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year) Significant visual impairment Prisoner Severe OSA in the past year (AHI is greater than 30 (more than 30 episodes per hour)) or ESS of 18 or more Co-enrollment with non-approved interventional trial Severe cognitive impairment (MOCA \< 10) or medications for cognitive decline Recent treatment for insomnia with CBT-I within the last 6 months
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06721819 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Delirium, Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06721819 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 406 participants.
Is NCT06721819 currently recruiting?
Yes, NCT06721819 is actively recruiting participants. Contact the research team at bsubrama@bidmc.harvard.edu for enrollment information.
Where is the NCT06721819 trial being conducted?
This trial is being conducted at Boston, United States, New York, United States, Columbus, United States.
Who is sponsoring the NCT06721819 clinical trial?
NCT06721819 is sponsored by Beth Israel Deaconess Medical Center. The trial plans to enroll 406 participants.