Recruiting

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

Sponsor:

University of Washington

Code:

NCT06411561

Conditions

Critical Illness

Delirium

Cognitive Impairment

Cognitive Decline

Alzheimer's Disease

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

SLEEP + COG

COG

SLEEP

Study Details

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

Study ID

NCT06411561

Start date

Dec 26, 2024

Status verified date

Jul, 2025

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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)

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SLEEP + COG

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

experimental: COG

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

experimental: SLEEP

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

active comparator: AC

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

Interventions

SLEEP + COG

Combination of SLEEP and COG interventions

COG

Daily 30-minute session of computerized cognitive training

SLEEP

Nighttime use of both ear plugs and eye masks

Educational modules on cognitive and sleep health

Primary outcome measure

Cognitive function [ Time Frame: Post-intervention/within 7 days of hospital discharge ]
Cognitive function [ Time Frame: Follow-up at 1 month post-hospital discharge ]
Cognitive function [ Time Frame: Follow-up at 6 months post-hospital discharge ]
Cognitive function [ Time Frame: Follow-up at 12 months post-hospital discharge ]

Central Contacts and Locations

Central contacts

Maya N Elias, PhD, MA, RN

206-543-8564 mnelias@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Maya N Elias, PhD, MA, RN

mnelias@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Jul 20, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2025-07-20.