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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: Recruiting Phase 3 study, sponsored by Beth Israel Deaconess Medical Center.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
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/
Primary Outcome
Positive CAM (Confusion Assessment Method) evaluation. : The Confusion Assessment Method (CAM) is a standardized evidence-based tool that enables non-psychiatrically trained clinicians to identify and recognize delirium quickly and accurately in both clinical and research settings. The CAM includes four features found to have the greatest ability to distinguish delirium from other types of cognitive impairment. Each feature is scored as present or absent. Delirium is considered present based on
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 |
What NCT06721819 shows while recruiting
NCT06721819 is an interventional study that assigns participants to a tested intervention. The registered 406 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT06721819 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06721819's enrollment target sits among peer trials
406 913th of 2000 higher than 1,087 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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