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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT06411561
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SLEEP + COG — BEHAVIORAL
    Combination of SLEEP and COG interventions
  • COG — BEHAVIORAL
    Daily 30-minute session of computerized cognitive training
  • SLEEP — BEHAVIORAL
    Nighttime use of both ear plugs and eye masks
  • AC — BEHAVIORAL
    Educational modules on cognitive and sleep health

Study Details

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.

Key Dates

Start date
Dec 26, 2024
Status verified
Jul 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Cognitive function [ Time Frame: Post-intervention/within 7 days of hospital discharge ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98195
Maya N Elias, PhD, MA, RN
[email protected]

Find similar trials in Seattle, WA

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
University of Washington· Seattle, WA

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