Dementia Clinical Trial
— SLEEP-COGOfficial title:
A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | May 31, 2027 |
Est. primary completion date | May 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - Age greater than or equal to 60 years old - Current hospitalization at University of Washington 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Washington | National Institute on Aging (NIA) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognitive function | RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance | Post-intervention/within 7 days of hospital discharge | |
Primary | Cognitive function | RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance | Follow-up at 1 month post-hospital discharge | |
Primary | Cognitive function | RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance | Follow-up at 6 months post-hospital discharge | |
Primary | Cognitive function | RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance | Follow-up at 12 months post-hospital discharge | |
Secondary | 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 | Post-intervention/within 7 days of hospital discharge | |
Secondary | 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 | Follow-up at 1 month post-hospital discharge | |
Secondary | 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 | Follow-up at 6 months post-hospital discharge | |
Secondary | 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 | Follow-up at 12 months post-hospital discharge | |
Secondary | Cognitive function: executive function, set-shifting | National Alzheimer's Coordinating Center Uniform Data Set: Oral Trail Making Test; time in seconds, range: 0-300; higher scores indicate worse performance | Post-intervention/within 7 days of hospital discharge | |
Secondary | Cognitive function: executive function, set-shifting | National Alzheimer's Coordinating Center Uniform Data Set: Oral Trail Making Test; time in seconds, range: 0-300; higher scores indicate worse performance | Follow-up at 1 month post-hospital discharge | |
Secondary | Cognitive function: executive function, set-shifting | National Alzheimer's Coordinating Center Uniform Data Set: Oral Trail Making Test; time in seconds, range: 0-300; higher scores indicate worse performance | Follow-up at 6 months post-hospital discharge | |
Secondary | Cognitive function: executive function, set-shifting | National Alzheimer's Coordinating Center Uniform Data Set: Oral Trail Making Test; time in seconds, range: 0-300; higher scores indicate worse performance | Follow-up at 12 months post-hospital discharge |
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