Clinical trial Recruiting at 1 site Interventional Ages 60 and up

Combining sleep promotion and cognitive training to improve brain function in older ICU survivors

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

Run by University of Washington · NCT06411561 · Data updated 2026-11-12

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

Study typeInterventional
Ages60 Years and up
SexAll
Enrollment100 (estimated)
SponsorUniversity of Washington
Academic / other
Locations1 site (Seattle, Washington)
StatusRecruiting
StartedDecember 26, 2024
Main results expectedMay 31, 2027
Study endsMay 31, 2027
Registry record updatedJuly 20, 2025
Trial IDNCT06411561 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients with a documented history of Alzheimer's disease, dementia, or severe cognitive impairments will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While the approach of combining sleep and cognitive interventions is innovative, similar studies have shown promise in improving cognitive outcomes in other populations.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.