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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Washington

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: SLEEP + COGExperimental treatment 1 intervention
Group B: COGExperimental treatment 1 intervention
Group C: SLEEPExperimental treatment 1 intervention
Group D: ACActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cognitive function

RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance

Time frame
Post-intervention/within 7 days of hospital discharge
2

Cognitive function

RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance

Time frame
Follow-up at 1 month post-hospital discharge
3

Cognitive function

RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance

Time frame
Follow-up at 6 months post-hospital discharge
4

Cognitive function

RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance

Time frame
Follow-up at 12 months post-hospital discharge

Secondary outcomes

1

Cognitive function: executive function, working memory

Wechsler Adult Intelligence Scale-III Digit Span Test-Backward; number of correct trials, range: 0-14; higher scores indicate better performance

Time frame
Post-intervention/within 7 days of hospital discharge
2

Cognitive function: executive function, working memory

Wechsler Adult Intelligence Scale-III Digit Span Test-Backward; number of correct trials, range: 0-14; higher scores indicate better performance

Time frame
Follow-up at 1 month post-hospital discharge
3

Cognitive function: executive function, working memory

Wechsler Adult Intelligence Scale-III Digit Span Test-Backward; number of correct trials, range: 0-14; higher scores indicate better performance

Time frame
Follow-up at 6 months post-hospital discharge
4

Cognitive function: executive function, working memory

Wechsler Adult Intelligence Scale-III Digit Span Test-Backward; number of correct trials, range: 0-14; higher scores indicate better performance

Time frame
Follow-up at 12 months post-hospital discharge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

National Institute on Aging (NIA)

Collaborator