Clinical trial NCT06411561: A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors
Official title: A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Delirium
Cognitive Impairment
Cognitive Decline
Alzheimer's Disease
Dementia
Circadian Dysrhythmia
Sleep Disturbance
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-05-13
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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
* 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

Primary outcomes:
measure: Cognitive function
timeFrame: Post-intervention/within 7 days of hospital discharge
measure: Cognitive function
timeFrame: Follow-up at 1 month post-hospital discharge
measure: Cognitive function
timeFrame: Follow-up at 6 months post-hospital discharge
measure: Cognitive function
timeFrame: Follow-up at 12 months post-hospital discharge
Secondary outcomes:
measure: Cognitive function: executive function, working memory
timeFrame: Post-intervention/within 7 days of hospital discharge
measure: Cognitive function: executive function, working memory
timeFrame: Follow-up at 1 month post-hospital discharge
measure: Cognitive function: executive function, working memory
timeFrame: Follow-up at 6 months post-hospital discharge
measure: Cognitive function: executive function, working memory
timeFrame: Follow-up at 12 months post-hospital discharge
measure: Cognitive function: executive function, set-shifting
timeFrame: Post-intervention/within 7 days of hospital discharge
measure: Cognitive function: executive function, set-shifting
timeFrame: Follow-up at 1 month post-hospital discharge
measure: Cognitive function: executive function, set-shifting
timeFrame: Follow-up at 6 months post-hospital discharge
measure: Cognitive function: executive function, set-shifting
timeFrame: Follow-up at 12 months post-hospital discharge
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Maya N Elias, PhD, MA, RN
role: PRINCIPAL_INVESTIGATOR
References: