NCT06411561 A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors
| NCT ID | NCT06411561 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Critical Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-12-26 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-12-26 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Maya N Elias, PhD, MA, RN
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT06411561 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06411561 currently recruiting?
Yes, NCT06411561 is actively recruiting participants. Contact the research team at mnelias@uw.edu for enrollment information.
Where is the NCT06411561 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT06411561 clinical trial?
NCT06411561 is sponsored by University of Washington. The principal investigator is Maya N Elias, PhD, MA, RN at University of Washington. The trial plans to enroll 100 participants.