About this trial
Up to 25% of intensive care unit (ICU) survivors experience cognitive impairment comparable in severity to mild Alzheimer's disease and related dementias after hospital discharge. Older ICU survivors (ages 60 and older) are at highest risk for delirium and subsequent cognitive impairment, which contribute to higher risk for cognitive decline related to Alzheimer's disease and related dementias. Sleep and activity are essential for recovery from critical illness, yet ICU survivors experience both sleep deficiency and profound inactivity. About 75-80% of ICU patients experience circadian dysrhythmia, which contributes to cognitive decline and increases likelihood of developing Alzheimer's disease and related dementias. The scientific premises of the proposed study are: 1) a combined sleep promotion and cognitive training intervention will have synergistic effects to mitigate the risk of cognitive impairment and development of Alzheimer's disease and related dementias in older ICU survivors; and 2) chronotherapeutic timing of interventions (i.e., adjusting timing of interventions according to circadian rhythm) may improve intervention efficacy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Factorial
Treatments tested in this trial
SLEEP + COG
BehavioralCombination of SLEEP and COG interventions
COG
BehavioralDaily 30-minute session of computerized cognitive training
SLEEP
BehavioralNighttime use of both ear plugs and eye masks
AC
BehavioralEducational modules on cognitive and sleep health
Treatment groups
Trial outcomes
Primary outcomes
Cognitive function
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Cognitive function
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Cognitive function
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Cognitive function
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Secondary outcomes
Cognitive function: executive function, working memory
Wechsler Adult Intelligence Scale-III Digit Span Test-Backward; number of correct trials, range: 0-14; higher scores indicate better performance
Cognitive function: executive function, working memory
Wechsler Adult Intelligence Scale-III Digit Span Test-Backward; number of correct trials, range: 0-14; higher scores indicate better performance
Cognitive function: executive function, working memory
Wechsler Adult Intelligence Scale-III Digit Span Test-Backward; number of correct trials, range: 0-14; higher scores indicate better performance
Cognitive function: executive function, working memory
Wechsler Adult Intelligence Scale-III Digit Span Test-Backward; number of correct trials, range: 0-14; higher scores indicate better performance
Sponsors and contacts
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University of Washington
Lead sponsor
National Institute on Aging (NIA)
Collaborator