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NCT06721819 · ClinicalTrials.gov registry record · Phase 3
The SCOPE Trial: Sleep, Cognition, and Pain Bundle vs. ERAS-cardiac for Postoperative Delirium
A Phase 3 study, sponsored by Beth Israel Deaconess Medical Center.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 406
- Enrollment target
NCT06721819 is a Phase 3 study that is actively recruiting participants, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 406 participants.
The verdict
NCT06721819, a Phase 3 study, is actively recruiting participants, sponsored by Beth Israel Deaconess Medical Center.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 406 participants
- Enrollment target
Study 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/
Interventions
- DRUG Control
- COMBINATION_PRODUCT Sleep Hygiene, Brain Game, and IV Acetaminophen Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2025-06-06 |
| Est. Completion | 2030-03-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06721819
The ClinicalTrials.gov registry entry for NCT06721819 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 406 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT06721819 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06721819 about?
NCT06721819 is a clinical study titled "The SCOPE Trial: Sleep, Cognition, and Pain Bundle vs. ERAS-cardiac for Postoperative Delirium". 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 be...
What is the current status of trial NCT06721819?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 406 participants. The study started on 2025-06-06. Estimated completion is 2030-03-31.
What interventions are being tested in trial NCT06721819?
The interventions under investigation include: Control (DRUG), Sleep Hygiene, Brain Game, and IV Acetaminophen Intervention (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06721819?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
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