A Pilot Study of Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST)
The primary goal of this randomized controlled trial is to test the feasibility and acceptability of preoperative sleep optimization (CBT-I) in orthopedic patients with moderate/severe insomnia. Secondary outcomes include cognitive, pain, and function.
- Sponsor: National Institute on Aging
- PI: Lei Gao, M.B.B.S., M.M.Sc.
- Co-I: Peng Li, Ph.D.; John Winkelman, M.D., Ph.D.
The figure above shows conceptual pathways linking sleep optimization, cognitive resilience, and brain health outcomes after surgery. NCD neurocognitive disorder; POD postoperative delirium; LOS length of stay. dCBT-I preoperative digital cognitive behavioral therapy for insomnia (hygiene, stimulus control, relaxation tools, cognitive restructuring). Feasibility results (Aim 1) will guide protocol adjustments and efficacy (Aim 2).
Sleep/Circadian Regulation and Progression to Postoperative Dementia
The goal of this grant is to test whether sleep/circadian regulation is associated with postoperative cognitive disorders, including delirium (POD), and progression to dementia within 12 months. It also tests whether the relationship is affected by AD genetic risk and AD pathology (plasma tau and amyloid).
- Sponsor: Alzheimer’s Association
- PI: Lei Gao, M.B.B.S., M.M.Sc.
The SCOPE Trial: Sleep, Cognition, and Pain Bundle vs. ERAS-Cardiac for Postoperative Delirium
The goal of this multisite randomized controlled trial is to test whether preoperative sleep optimization with cognitive behavioral therapy for insomnia, cognitive (brain puzzle) training, and scheduled intravenous acetaminophen use over 48 hours is superior to the current Enhanced Recovery (ERAS) for Cardiac Surgery protocol in the prevention of postoperative delirium (POD). Responsible for the overall study and specifically will lead the sleep CBT-I intervention and Chair of the Digital Technology Committee.
- Sponsor: Patient-Centered Outcomes Research Institute (PCORI)
- Co-PIs: Lei Gao, M.B.B.S., M.M.Sc.; Balachundhar Subramaniam, M.D., M.PH, FASA
Multisite randomized controlled trail that will enroll 406 patients undergoing cardiac surgery to test whether a novel sleep optimization, cognition prehabilitation, and analgesia bundle is superior to established ERAS (enhanced recovery after surgery) standard of care protocols (figure below).
Circadian Multiscale Activity Regulation and the Risk for Delirium in Elderly Hospitalized Patients
As part of the Grants for Early Medical/Surgical Specialists’ Transition to Aging Research (GEMSSTAR) award, this project aims to determine whether the multiscale regulation of motor activity can be a sensitive biomarker of delirium in the elderly.
- Sponsor: National Institute on Aging
- PI: Lei Gao, M.B.B.S., M.M.Sc.