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A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors
NCT06411561 · University of Washington
In plain English
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About this study
Using a 2 x 2 factorial design, 100 English- or Spanish-speaking older ICU survivors will be enrolled after discharge out of ICU and randomized to one of 4 combinations of two interventions: SLEEP and COG. We propose that the combination of a nighttime sleep promotion intervention \[SLEEP: nighttime use of earplugs and eye masks\] and a daytime computerized cognitive training intervention \[COG: daily 30-minute cognitive training sessions\] may produce synergistic effects on cognitive function to mitigate delirium and reduce risk of incident Alzheimer's disease and related dementias. Because circadian dysrhythmia contributes to cognitive decline, chronotherapeutic timing of the COG intervention could maximize intervention efficacy.
Specific Aim 1: Test the separate and combined effects of SLEEP and COG \[SLEEP + COG, SLEEP, COG\] versus an active control \[AC\] in improving cognitive function for older ICU survivors.
Specific Aim 2: Examine circadian rhythm parameters of continuous body temperature (iButton: wearable sensor) to determine the optimal window for timing of the COG intervention.
Specific Aim 3: Examine if the effects of each intervention on cognitive function are mediated by sleep and activity, and examine if selected biological and clinical factors moderate intervention effects.
Exploratory Aim 4: Explore the effect of each intervention on cognitive function at 1 month and incident Alzheimer's disease and related dementias at 6 months and 12 months post-hospital discharge.
Eligibility criteria
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
Study design
Enrollment target: 100 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2024-12-26
Estimated completion: 2027-05-31
Last updated: 2025-07-20
Interventions
Behavioral: SLEEP + COGBehavioral: COGBehavioral: SLEEPBehavioral: AC
Primary outcomes
- • Cognitive function (Post-intervention/within 7 days of hospital discharge)
- • Cognitive function (Follow-up at 1 month post-hospital discharge)
- • Cognitive function (Follow-up at 6 months post-hospital discharge)
Sponsor
University of Washington · other
With: National Institute on Aging (NIA)
Contacts & investigators
ContactMaya N Elias, PhD, MA, RN · contact · mnelias@uw.edu · 206-543-8564
InvestigatorMaya N Elias, PhD, MA, RN · principal_investigator, University of Washington
All locations (1)
University of WashingtonRecruiting
Seattle, Washington, United States