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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-26

Study Completion Date

2027-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

SLEEP + COG

Intervention Type BEHAVIORAL

Combination of SLEEP and COG interventions

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

Group Type EXPERIMENTAL

COG

Intervention Type BEHAVIORAL

Daily 30-minute session of computerized cognitive training

SLEEP

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

Group Type EXPERIMENTAL

SLEEP

Intervention Type BEHAVIORAL

Nighttime use of both ear plugs and eye masks

AC

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

Group Type ACTIVE_COMPARATOR

AC

Intervention Type BEHAVIORAL

Educational modules on cognitive and sleep health

Interventions

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SLEEP + COG

Combination of SLEEP and COG interventions

Intervention Type BEHAVIORAL

COG

Daily 30-minute session of computerized cognitive training

Intervention Type BEHAVIORAL

SLEEP

Nighttime use of both ear plugs and eye masks

Intervention Type BEHAVIORAL

AC

Educational modules on cognitive and sleep health

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No