Sleep, Cognition, and Pain Bundle versus ERAS‑cardiac to Prevent Delirium After Heart Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The SCOPE trial compares a multicomponent intervention—pre- and post-operative sleep optimization, preoperative cognitive exercises delivered via provided tablets and wearables, and 48 hours of IV acetaminophen for opioid-sparing pain control—added to standard ERAS‑cardiac versus ERAS protocols alone. Eligible participants are adults aged 60 or older scheduled for planned median sternotomy cardiac surgery (CABG with or without valve, or isolated valve surgery) with cardiopulmonary bypass, recruited at major academic centers. The study tracks postoperative delirium incidence and duration as primary outcomes and follows secondary outcomes including cognitive and physical function, sleep quality, pain, mood, and survival. Participants randomized to the intervention are asked to use the provided devices and commit about one hour per day before surgery to the cognitive and behavioral components.

Why it matters

Who can join: the full rules

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

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Columbia University Irving Medical Center
  New York, New York, United States Recruiting
• The Ohio State University
  Columbus, Ohio, United States Recruiting

Study contacts

• Study coordinator: Balachundhar Subramaniam, MD/MPH
• Email: bsubrama@bidmc.harvard.edu
• Phone: 7814750572

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.