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New treatment option for Delirium, Postoperative
Official title The SCOPE Trial: Sleep, Cognition, and Pain Bundle vs. ERAS-cardiac for Postoperative Delirium
ClinicalTrials.gov ID: NCT06721819
What this study is testing
What is Sleep Hygiene, Brain Game, and IV Acetaminophen Intervention?
Sleep Hygiene, Brain Game, and IV Acetaminophen Intervention is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for delirium, postoperative.
Also referred to as CBT-I, Lumosity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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...
See the full eligibility 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 assigned by...
- 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 treatment trial
- Severe cognitive impairment (MOCA \< 10) or medications for cognitive decline
- Recent treatment for insomnia with CBT-I within the last 6 months
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- New York, New York, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; New York, New York, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.