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Behavioural Intervention

Timing of Cognitive Training for ICU Survivors' Cognitive Impairment (OPTIMIZE Trial)

N/A

Recruiting

Led By Maya Elias

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Active transfer order or expected discharge from ICU to a post-ICU unit

Age ≥ 60 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days

Awards & highlights

OPTIMIZE Trial Summary

This trial will examine the optimal timing of cognitive interventions to improve cognitive function in older adults in ICU. It will compare a morning vs. late afternoon/evening session to standard care.

Who is the study for?

This trial is for ICU survivors aged 60 or older who have stayed in the ICU for at least 24 hours, are fluent in English, and were independent before hospital admission. It's not for those with severe arm paralysis, recent stroke or brain injury, multiple ICU stays this admission, Alzheimer's/dementia history or anti-dementia meds use, bipolar disorder/schizophrenia history, or severe visual impairment.Check my eligibility

What is being tested?

The study tests if computerized cognitive training (COG) helps improve cognitive function when done at different times: morning (COG-AM) vs. late afternoon/evening (COG-PM), compared to standard care. It also looks into how these sessions affect circadian rhythms and whether daytime activity influences the outcomes.See study design

What are the potential side effects?

Since COG involves non-invasive computer activities there may be minimal side effects such as eye strain from screen time or potential frustration with tasks; however specific side effects will be monitored during the trial.

OPTIMIZE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am being moved from the ICU to a regular hospital unit soon.

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I am 60 years old or older.

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I do not have Alzheimer's disease or dementia.

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I have stayed in the ICU for at least 24 hours.

OPTIMIZE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of afternoon/evening-only sessions of computerized cognitive training

Acceptability of morning-only sessions of computerized cognitive training

Feasibility of afternoon/evening-only sessions of computerized cognitive training

+1 more

Secondary outcome measures

Activity counts per minute

Circadian rhythm of continuous body temperature

Cognitive function

+1 more

OPTIMIZE Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: COG-PMExperimental Treatment1 Intervention

30-minute afternoon/evening session of a computerized cognitive training intervention (Lumosity), delivered between the hours of 15:00 PM - 18:00 PM, in addition to UC

Group II: COG-AMExperimental Treatment1 Intervention

30-minute morning session of a computerized cognitive training intervention (Lumosity), delivered between the hours of 09:00 AM - 12:00 PM, in addition to UC

Group III: UCActive Control1 Intervention

Standard post-ICU inpatient care/usual care

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

American Association of Critical-Care NursesUNKNOWN

2 Previous Clinical Trials

141 Total Patients Enrolled

1 Trials studying Critical Illness

91 Patients Enrolled for Critical Illness

American Association of Critical Care NursesOTHER

3 Previous Clinical Trials

141 Total Patients Enrolled

1 Trials studying Critical Illness

91 Patients Enrolled for Critical Illness

University of WashingtonLead Sponsor

1,741 Previous Clinical Trials

1,847,720 Total Patients Enrolled

6 Trials studying Critical Illness

2,531 Patients Enrolled for Critical Illness

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary objective of this clinical endeavor?

"The primary purpose of this short-term clinical trial, which is expected to be completed in seven days, will assess the viability of using computerized cognitive training sessions during late afternoon and evening hours. Secondary objectives include analyzing Circadian rhythm parameters with regards to Continuous body temperature via cosinor analysis, exploring the effect on daytime Activity counts per minute through wrist actigraphy, and estimating Total sleep time in minutes at nighttime with wrist actigraphy."

Answered by AI

Is enrollment for this research project still open?

"Affirmative. According to information on clinicaltrials.gov, this medical experiment is currently seeking participants and was first listed on November 15th 2023 with the latest edit made one day later. The trial requires 40 individuals from a single clinic for successful completion."

Answered by AI

How many participants are implicated in this investigation?

"That is correct. The details found on clinicaltrials.gov show that this medical trial, which was posted on November 15th 2023, is actively seeking participants. 40 individuals are projected to be recruited from a singular site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimal Timing of Computerized Cognitive Training for Older Intensive Care Unit Survivors

Maya Elias 2023. "Optimal Timing of Computerized Cognitive Training for Older Intensive Care Unit Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05467410.

All > Delayed Sleep Phase Syndrome