NCT06411561 · University of Washington
A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors
(SLEEP-COG)
What this study is about
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.
View original scientific description
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.
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
Primary outcome measures
Cognitive function
Time frame: Post-intervention/within 7 days of hospital discharge
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Cognitive function
Time frame: Follow-up at 1 month post-hospital discharge
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Cognitive function
Time frame: Follow-up at 6 months post-hospital discharge
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Cognitive function
Time frame: Follow-up at 12 months post-hospital discharge
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Seattle, Washington
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 20, 2025 · Source of record for eligibility and locations