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

NCT06411561 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-07-20

No results posted yet for this study

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

Interventions

BEHAVIORAL

SLEEP + COG

Combination of SLEEP and COG interventions

BEHAVIORAL

COG

Daily 30-minute session of computerized cognitive training

BEHAVIORAL

SLEEP

Nighttime use of both ear plugs and eye masks

BEHAVIORAL

AC

Educational modules on cognitive and sleep health

Sponsors & Collaborators

Principal Investigators

  • Maya N Elias, PhD, MA, RN · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-26
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06411561 on ClinicalTrials.gov