A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors (SLEEP-COG)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Delirium; Critical Illness; Cognitive Impairment; Dementia; Sleep Disturbance; Cognitive Decline; Alzheimer's Disease; Circadian Dysrhythmia
• Intervention / Treatment: Behavioral: SLEEP + COG; Behavioral: COG; Behavioral: SLEEP; Behavioral: AC

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maya N Elias, PhD, MA, RN; Phone Number: 206-543-8564; Email: mnelias@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SLEEP + COG; Combination of SLEEP and COG interventions, for up to 5 days/nights + usual post-ICU inpatient care; Personalized timing of morning COG sessions or evening COG sessions, based on CSM scale at baseline	Behavioral: SLEEP + COG; Combination of SLEEP and COG interventions
Experimental: COG; Daily 30-minute computerized cognitive training sessions (Lumosity), for up to 5 days + usual post-ICU inpatient care; Personalized timing of morning COG sessions or evening COG sessions, based on CSM scale at baseline	Behavioral: COG; Daily 30-minute session of computerized cognitive training
Experimental: SLEEP; -Nighttime use of earplugs and eye masks, for up to 5 nights + usual post-ICU inpatient care	Behavioral: SLEEP; Nighttime use of both ear plugs and eye masks
Active Comparator: AC; -Active control; delivery of educational modules on sleep and cognitive health + usual post-ICU inpatient care	Behavioral: AC; Educational modules on cognitive and sleep health

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function	RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance	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	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	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	Follow-up at 12 months post-hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	Follow-up at 12 months post-hospital discharge

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Maya N Elias, PhD, MA, RN, University of Washington

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Disease Attributes; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction; Critical Illness
• Other Study ID Numbers: STUDY00018228; K23AG078448 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No