Actively Recruiting
A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors
Led by University of Washington · Updated on 2025-07-20
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a combined sleep promotion and cognitive training intervention to help improve cognitive function in older survivors of intensive care units (ICU). This study focuses on adults aged 60 and older who are at high risk for delirium and cognitive decline similar to mild Alzheimer's disease after ICU discharge. The study aims to assess whether these interventions can reduce the risk of developing Alzheimer's disease and related dementias by addressing sleep deficiency, inactivity, and circadian rhythm disturbances common in ICU survivors. Participants will be randomly assigned to one of four groups: a combination of nighttime sleep promotion using earplugs and eye masks plus daily 30-minute computerized cognitive training sessions; cognitive training alone; sleep promotion alone; or an active control group receiving educational modules on brain health. The interventions last up to seven days following ICU discharge, with cognitive training sessions scheduled based on individual circadian rhythms measured by a wearable sensor. During the study, participants will be monitored using body temperature sensors to optimize the timing of cognitive training. Researchers will assess cognitive function, including executive function and working memory, at several time points: within seven days after hospital discharge, and at one, six, and twelve months follow-up. The study also examines how sleep and activity may influence cognitive outcomes, with safety and ongoing care monitored throughout the study period, which concludes in May 2027.
CONDITIONS
Brief Title
A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than or equal to 60 years old
- Current hospitalization at University of Washington Medical Center or Harborview Medical Center
- Intensive care unit (ICU) length of stay greater than 24 hours
- Recovery from critical care status to acute care status, and/or discharge out of ICU
- Fluent in English or Spanish
- Functional independence on activities of daily living prior to hospitalization (Katz Index = 6)
You will not qualify if you...
- Documented history or suspicion of Alzheimer's disease or dementia, or current prescription of anti-dementia medication
- Documented history of bipolar disorder or schizophrenia
- Documented acute stroke or traumatic brain injury
- Severe vision impairment
- Severe hearing impairment
- Severe paralysis or dominant arm paresis
- Transfer from skilled nursing care facility or inpatient rehabilitation facility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days
Participants receive one of four interventions after ICU discharge: nighttime use of earplugs and eye masks (SLEEP), daily 30-minute computerized cognitive training sessions (COG), a combination of both (SLEEP + COG), or educational modules on brain and sleep health (active control). The timing of cognitive training sessions is personalized based on baseline assessments.
Daily visits or sessions for up to 7 days
Duration - 12 months
Participants are assessed for cognitive function at 1 month, 6 months, and 12 months after hospital discharge to evaluate the lasting effects of the interventions.
3 follow-up visits at 1, 6, and 12 months post-discharge
Trial Site Locations
Total: 1 location
1
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
M
Maya N Elias, PhD, MA, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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