Combining sleep promotion and cognitive training to improve brain function in older ICU survivors
A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors
NA · University of Washington · NCT06411561
This study is testing if helping older adults who survived ICU treatment sleep better and do brain exercises can improve their thinking skills.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of Washington (other) |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06411561 on ClinicalTrials.gov |
What this trial studies
This study aims to address cognitive impairment in older adults who have survived intensive care unit (ICU) treatment. It employs a 2 x 2 factorial design to randomly assign 100 English- or Spanish-speaking participants, aged 60 and older, to one of four intervention groups: a combination of sleep promotion and cognitive training, sleep only, cognitive training only, or an active control. The interventions focus on enhancing sleep quality through earplugs and eye masks at night, alongside daily cognitive training sessions to improve cognitive function. The study will also monitor circadian rhythms to optimize the timing of cognitive training for maximum effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are older adults aged 60 and above who have been hospitalized in an ICU for more than 24 hours and are recovering from critical care.
Not a fit: Patients with a documented history of Alzheimer's disease, dementia, or severe cognitive impairments will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the risk of cognitive decline and Alzheimer's disease in older ICU survivors.
How similar studies have performed: While the approach of combining sleep and cognitive interventions is innovative, similar studies have shown promise in improving cognitive outcomes in other populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seattle, Washington
- University of Washington — Seattle, Washington, United States (RECRUITING)
Study contacts
- Principal investigator: Maya N Elias, PhD, MA, RN — University of Washington
- Study coordinator: Maya N Elias, PhD, MA, RN
- Email: mnelias@uw.edu
- Phone: 206-543-8564
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Critical Illness, Delirium, Cognitive Impairment, Cognitive Decline, Alzheimer's Disease, Dementia, Circadian Dysrhythmia, Sleep Disturbance