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

NCT06411561 | Recruiting DMC

• 2 other identifiers: STUDY00018228K23AG078448
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Delirium; Cognitive Impairment; Cognitive Decline; Alzheimer's Disease; Dementia; Circadian Dysrhythmia; Sleep Disturbance

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Cognitive function: executive function, working memory

  Post-intervention/within 7 days of hospital discharge

• Cognitive function: executive function, working memory

  Follow-up at 1 month post-hospital discharge

• Cognitive function: executive function, working memory

  Follow-up at 6 months post-hospital discharge

• Cognitive function: executive function, working memory

  Follow-up at 12 months post-hospital discharge

• Cognitive function: executive function, set-shifting

  Post-intervention/within 7 days of hospital discharge

Study Arms (4)

SLEEP + COG

EXPERIMENTAL

* Combination of SLEEP and COG interventions, for up to 7 days/nights + usual post-ICU inpatient care * Personalized timing of morning, afternoon, or evening COG sessions, based on CSM scale at baseline

Behavioral: SLEEP + COG

COG

EXPERIMENTAL

* Daily 30-minute computerized cognitive training sessions (Lumosity), for up to 7 days + usual post-ICU inpatient care * Personalized timing of morning, afternoon, or evening COG intervention sessions, based on CSM scale at baseline

Behavioral: COG

SLEEP

EXPERIMENTAL

\- Nighttime use of earplugs and eye masks, for up to 7 nights + usual post-ICU inpatient care

Behavioral: SLEEP

AC

ACTIVE COMPARATOR

\- Active comparator condition; delivery of educational modules on brain health + usual post-ICU inpatient care

Behavioral: AC

Interventions

SLEEP + COG BEHAVIORAL

Combination of SLEEP and COG interventions

SLEEP + COG

COG BEHAVIORAL

Daily 30-minute session of computerized cognitive training

COG

SLEEP BEHAVIORAL

Nighttime use of both ear plugs and eye masks

SLEEP

AC BEHAVIORAL

Educational modules on cognitive and sleep health

AC

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Critical Illness; Delirium; Cognitive Dysfunction; Alzheimer Disease; Dementia; Parasomnias

Interventions

Sleep

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Maya N Elias, PhD, MA, RN

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya N Elias, PhD, MA, RN

CONTACT

206-543-8564; mnelias@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Nursing

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: May 13, 2024
• Study Start: December 26, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

US (1)