Sleep, Cognition, and Pain Bundle for Delirium

(SCOPE Trial)

Not yet recruiting at 2 trial locations

Overseen By Lei Gao, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Opioids, Cognitive decline meds

Disqualifiers: Liver dysfunction, Alcohol abuse, Severe OSA, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to prevent confusion and cognitive decline after heart surgery. The treatment, called the SCOPE Bundle, includes sleep optimization, brain exercises, and pain management with intravenous acetaminophen (a non-opioid pain reliever) to reduce inflammation and improve recovery. The researchers aim to determine if these combined efforts can lower the risk of delirium (sudden confusion) and enhance overall outcomes such as sleep quality, mood, and physical function. Individuals scheduled for heart surgery who are willing to engage in sleep and cognitive exercises before the procedure might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using chronic opioids for pain or medications for cognitive decline, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the SCOPE bundle, which includes sleep improvement, brain exercises, and intravenous acetaminophen, is generally well-tolerated by patients. Studies have found that similar treatments can effectively reduce issues like delirium (confusion and agitation) in patients recovering from surgery.

Intravenous acetaminophen, used in the SCOPE bundle for pain relief, is a common hospital medication. It is gentle on the stomach and lacks the addiction risk associated with stronger painkillers like opioids. Although acetaminophen is usually safe, very high doses can harm the liver. The trial, however, uses controlled doses to minimize this risk.

The sleep and brain exercises in the trial are non-invasive and have been linked to better mental function and less confusion after surgery. Improving sleep through healthy habits is a standard and safe approach.

Since this trial is in a later phase, earlier studies have shown the treatment to be safe for further testing. Participants can feel reassured that the SCOPE bundle has passed thorough safety checks before reaching this stage. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SCOPE Bundle because it offers a comprehensive approach to managing delirium by targeting sleep, cognition, and pain all at once, which is quite different from current treatments that typically focus on just one of these aspects. The bundle includes a sleep hygiene protocol paired with cognitive exercises using brain games, which are innovative in pre-surgery preparation. Additionally, the use of IV acetaminophen post-surgery provides a non-opioid option for pain management, which is crucial for reducing potential side effects and dependency issues associated with opioids. This integrated strategy aims to enhance recovery and improve overall outcomes, making it a promising option for patients undergoing surgery.

What evidence suggests that the SCOPE bundle could be effective for reducing delirium after heart surgery?

This trial compares two approaches to managing delirium risk after heart surgery. Research has shown that improving sleep, engaging in brain exercises, and effectively managing pain can lower the risk of confusion post-surgery. Participants in one arm of the trial will follow a sleep hygiene protocol and engage in brain exercises before surgery, combined with postoperative intravenous acetaminophen. Better sleep and mental exercises can help the brain handle stress more effectively. Participants in the other arm will follow an ERAS protocol with three doses of intravenous acetaminophen postoperatively. Using intravenous acetaminophen for pain can reduce swelling and lessen the need for opioids, which may increase the risk of confusion. These steps aim to protect brain function and aid recovery. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for heart surgery patients aged 60 or older who have their operation scheduled at least two weeks away. They must be willing to use a tablet, wear devices, and spend an hour daily on pre-surgery interventions if assigned to the experimental group. Exclusions include liver dysfunction, known drug allergies, heavy alcohol use in the past year, baseline delirium, severe visual or sleep apnea issues, chronic opioid use, and certain cognitive impairments.

Inclusion Criteria

I am willing to use a tablet and wearables for daily health activities for an hour.

I am 60 years old or older.

I am scheduled for heart surgery with a chest bone cut and heart-lung machine use in at least two weeks.

Exclusion Criteria

I have received CBT-I for insomnia in the last 6 months.

Known hypersensitivity to the study drugs

Delirium at baseline

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Intervention

Participants undergo sleep optimization and cognitive exercise training for two weeks before surgery

2 weeks

Regular check-ins (virtual)

Surgery and Immediate Postoperative Care

Participants undergo cardiac surgery followed by immediate postoperative care including IV acetaminophen administration

48 hours

Inpatient hospital stay

Follow-up

Participants are monitored for delirium incidence and other outcomes such as cognitive and physical function, sleep quality, and mood

12 months

Regular follow-up visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• SCOPE Bundle

Trial Overview The SCOPE Trial tests a bundle of interventions (sleep optimization techniques, brain exercises before surgery using games/apps on tablets and extended pain relief with IV acetaminophen) against standard postoperative care to see if they reduce confusion/delirium after heart surgery and improve long-term health outcomes like cognition and physical function.

How Is the Trial Designed?

Group I: Sleep Hygiene, brain games, and IV Acetaminophen bundle intervention Experimental Treatment 1 Intervention

Preoperative Intervention: Two weeks of following a sleep hygiene protocol and 10 hours minimum of playing brain games. Cognitive Exercise: Patients will be given an iPad, which will be pre-installed with access to Lumosity, a cognitive exercise software application. Participants will be instructed to try and complete 1 hour of Lumosity exercise daily prior to surgery, with a pre-operative cognitive exercise goal of 10 hours. Sleep Hygiene: Preoperatively, investigators will deliver the digital CBT-I, (Cognitive Behavioral Therapy- Insomnia) over 2 weeks before surgery and in parallel to cognitive exercise. Postoperative Intervention: Eight doses of IV acetaminophen at 1000g each dose delivered every 6 hours for the first 48 hours within 1 hour of admission to CVICU. Acetaminophen administration in any form other than the blinded study medication during this time will not be allowed.

Group II: ERAS Protocol with three doses IV Acetaminophen Active Control 1 Intervention

No preoperative intervention and three doses of IV acetaminophen (as following ERAS protocol) at 1000mg per dose within 48 hours post operatively. Control patients will be on intravenous acetaminophen for the first 24 hours (three doses at 8 hourly intervals).

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

A quality improvement intervention in a medical ICU involving sleep-promoting strategies led to significant reductions in perceived nighttime noise and the incidence of delirium/coma among 300 patients, indicating a positive impact on patient cognition and comfort.

While the intervention did not significantly improve overall perceived sleep quality, it was associated with a higher number of delirium/coma-free days, suggesting that the strategies implemented were effective in enhancing patient outcomes in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a quality improvement intervention on perceived sleep quality and cognition in a medical ICU. Kamdar, BB., King, LM., Collop, NA., et al.[2022]

In a study involving 94 patients with acute brain injury, an intervention targeting sedation, sleep, pain, and mobilization did not significantly reduce the prevalence or duration of delirium compared to standard care.

Despite the high prevalence of delirium (90% in standard care and 88% in the intervention group), the intervention did not lead to improvements in ICU length of stay or one-year mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delirium prevalence and prevention in patients with acute brain injury: A prospective before-and-after intervention study. Larsen, LK., Møller, K., Petersen, M., et al.[2020]

Citations

1. withpower.com withpower.com/trial/phase-3-delirium-1-2025-9d1b6

Sleep, Cognition, and Pain Bundle for Delirium Investigators aim to test a bundle of sleep optimization, cognitive exercise before surgery, and extended pain relief for 48 hours with intravenous ...

2. alicantobidmc.org alicantobidmc.org/index.php/resources/scope-trial-sleep-cognition-and-pain-bundle-vs-eras-cardiac-postoperative-delirium

Sleep, Cognition, and Pain Bundle Vs. ERAS-cardiac for ... SCOPE-bundle patients will receive eight doses of IV acetaminophen over 48 hours (compared to standard pain management for ERAS includes ...

3. pcori.org pcori.org/research-results/2023/scope-trial-sleep-cognition-and-pain-bundle-versus-enhanced-recovery-after-surgery-cardiac-postoperative-delirium

The SCOPE Trial: Sleep, Cognition, and Pain Bundle ... The SCOPE Trial: Sleep, Cognition, and Pain Bundle Versus Enhanced Recovery After Surgery-Cardiac for Postoperative Delirium. Project Summary.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06721819/the-scope-trial-sleep-cognition-and-pain-bundle-vs-eras-cardiac-for-postoperative-delirium

The SCOPE Trial: Sleep, Cognition, and Pain Bundle Vs. ... Investigators aim to test a bundle of sleep optimization, cognitive exercise before surgery, and extended pain relief for 48 hours with ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7803454/

Effectiveness of Bundle Interventions on ICU Delirium This meta-analysis fails to support that bundle interventions are effective in reducing ICU delirium prevalence and duration.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41185378/

An Umbrella Meta-Analysis of Randomised Clinical Trials ... Conclusions: This umbrella meta-analysis provides moderate to high-certainty evidence supporting the efficacy of bundle interventions in reducing ICU delirium ...