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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Combination of SLEEP and COG interventions
Daily 30-minute session of computerized cognitive training
Nighttime use of both ear plugs and eye masks
Educational modules on cognitive and sleep health
University of Washington
Seattle, Washington, United States
RECRUITINGCognitive function
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Time frame: Post-intervention/within 7 days of hospital discharge
Cognitive function
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Time frame: Follow-up at 1 month post-hospital discharge
Cognitive function
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Time frame: Follow-up at 6 months post-hospital discharge
Cognitive function
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Time frame: Follow-up at 12 months post-hospital discharge
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
Time frame: Post-intervention/within 7 days of hospital discharge
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
Time frame: Follow-up at 1 month post-hospital discharge
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
Time frame: Follow-up at 6 months post-hospital discharge
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
Time frame: Follow-up at 12 months post-hospital discharge
Cognitive function: executive function, set-shifting
National Alzheimer's Coordinating Center Uniform Data Set: Oral Trail Making Test; time in seconds, range: 0-300; higher scores indicate worse performance
Time frame: Post-intervention/within 7 days of hospital discharge
Cognitive function: executive function, set-shifting
National Alzheimer's Coordinating Center Uniform Data Set: Oral Trail Making Test; time in seconds, range: 0-300; higher scores indicate worse performance
Time frame: Follow-up at 1 month post-hospital discharge
Cognitive function: executive function, set-shifting
National Alzheimer's Coordinating Center Uniform Data Set: Oral Trail Making Test; time in seconds, range: 0-300; higher scores indicate worse performance
Time frame: Follow-up at 6 months post-hospital discharge
Cognitive function: executive function, set-shifting
National Alzheimer's Coordinating Center Uniform Data Set: Oral Trail Making Test; time in seconds, range: 0-300; higher scores indicate worse performance
Time frame: Follow-up at 12 months post-hospital discharge
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