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Active, Not Recruiting

NCT Number: NCT05467410

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

More than 60% of intensive care unit (ICU) patients are adults ages 60 and older, who are at high risk for ICU-acquired cognitive impairment. After ICU discharge, ICU survivors often experience sleep disturbances and inactivity, and almost 80% of ICU patients experience disturbances in circadian rhythm, which may affect cognitive function. Understanding the optimal, chronotherapeutic timing of cognitive interventions is crucial to promote circadian realignment and cognitive function, and may improve intervention feasibility, acceptability, and efficacy. Specific Aim 1 will determine feasibility, acceptability, and preliminary effect sizes for: 1) a morning session of a computerized cognitive training intervention [COG]; and 2) a late afternoon/early evening session of the COG intervention; compared to 3) standard inpatient care/usual care [UC]. Specific Aim 2 will examine circadian rhythm parameters to determine the optimal timing of the daily COG intervention. Exploratory Aim 3 will explore if the effects of the COG intervention on cognitive function are mediated by daytime activity, and explore if selected biological and clinical factors moderate intervention effects on cognitive function.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harborview Medical Center, Seattle, Washington, United States

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About this study

Over 60% of intensive care unit (ICU) patients are older adults (ages 60 and older). Up to 40% of ICU survivors experience cognitive impairment that is comparable in severity to moderate traumatic brain injury, while 25% have symptoms similar to mild Alzheimer's disease after hospital discharge. Older ICU survivors are at high risk for ICU-acquired cognitive impairment, often leading to a protracted recovery in a care facility. Several factors, including circadian misalignment (observed in about 75-80% of ICU patients), may decrease effects of interventions designed to improve cognitive function. Further, daytime activity is essential for recovery from critical illness and to promote circadian realignment, yet ICU survivors experience profound inactivity. The scientific premise of the proposed research is that identifying the optimal circadian timing of cognitive interventions for older ICU survivors may improve intervention feasibility, acceptability, and efficacy. Interventions targeting symptoms (i.e., disturbances in circadian rhythm and cognitive impairment) may deliver similar outcomes across conditions that require ICU admission (e.g., cancer, heart failure, pneumonia, hip fracture). To date, interventions have not been evaluated in older ICU survivors that simultaneously target circadian misalignment and cognitive impairment. Moreover, because circadian misalignment adversely affects cognitive function, understanding the optimal timing of cognitive interventions is crucial to promote both circadian realignment and cognitive function. Specific Aim 1 will determine feasibility, acceptability, and preliminary effect sizes for: 1) a morning session of a computerized cognitive training intervention [COG]; and 2) a late afternoon/early evening session of the COG intervention; compared to 3) standard inpatient care/usual care [UC]. Specific Aim 2 will examine circadian rhythm parameters to determine the optimal timing of the daily COG intervention. Exploratory Aim 3 will explore if the effects of the COG intervention on cognitive function are mediated by daytime activity, and explore if selected biological and clinical factors moderate intervention effects on cognitive function. The proposed early-stage clinical trial will be the first to evaluate chronotherapeutic timing of a computerized cognitive training intervention for hospitalized older ICU survivors after ICU discharge, to initiate early cognitive recovery on a post-ICU unit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 60 years
  • ICU length of stay ≥ 24 hours
  • Active transfer order or expected discharge from ICU to a post-ICU unit
  • Fluent in English
  • Functional independence prior to hospital admission (Katz Index = 6)
  • No suspicion of Alzheimer's disease/dementia
  • Current hospitalization at University of Washington Medical Center or Harborview Medical Center

Exclusion criteria

  • Documented history or suspicion of Alzheimer's disease/dementia, or current prescription of anti-dementia medication
  • Documented history of bipolar disorder or schizophrenia
  • Documented acute stroke or acute traumatic brain injury
  • Severe visual impairment
  • Severe hearing impairment
  • Severe dominant arm paresis/paralysis
  • Transfer from inpatient rehabilitation or skilled nursing care facility

Treatment and study plan

COG-AM

Behavioral

Participants who are randomized to the COG-AM intervention group will be asked to complete 30-minute computerized cognitive training (Lumosity cognitive training program) sessions during morning hours (between 09:00-12:00), for a total of 7 days or until hospital discharge, whichever comes first. Participants will complete cognitive training sessions in each of the following subdomains: memory, attention, problem solving, cognitive flexibility, and processing speed.

COG-PM

Behavioral

Participants who are randomized to the COG-PM intervention group will be asked to complete 30-minute computerized cognitive training (Lumosity cognitive training program) sessions during late afternoon/early evening hours (between 15:00-18:00), for a total of 7 days or until hospital discharge, whichever comes first. Participants will complete cognitive training sessions in each of the following subdomains: memory, attention, problem solving, cognitive flexibility, and processing speed.

Primary outcomes

  1. Feasibility of morning-only sessions of computerized cognitive training

    Time frame: 7 days

    A retention rate of >70% will determine feasibility: the percentage of participants who complete at least 60 minutes of COG-AM sessions and all cognitive outcome assessments. Adherence to the COG-AM intervention will be defined as the proportion of minutes spent training by the total minutes required per protocol (total minutes trained / [30 minutes x number of intervention days]).

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

    Time frame: 7 days

    A retention rate of >70% will determine feasibility: the percentage of participants who complete at least 60 minutes of COG-PM sessions and all cognitive outcome assessments. Adherence to the COG-PM intervention will be defined as the proportion of minutes spent training by the total minutes required per protocol (total minutes trained / [30 minutes x number of intervention days]).

  3. Acceptability of morning-only sessions of computerized cognitive training

    Time frame: 7 days

    Likert-type surveys including open-ended questions will be collected regarding acceptability of the COG-AM intervention. To evaluate tolerability, reasons why participants were unable to complete COG-AM sessions in their entirety will be recorded.

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

    Time frame: 7 days

    Likert-type surveys including open-ended questions will be collected regarding acceptability of the COG-PM intervention. To evaluate tolerability, reasons why participants were unable to complete COG-PM sessions in their entirety will be recorded.

Secondary outcomes

  1. Cognitive function: global cognition

    Time frame: 7 days

    National Alzheimer's Coordinating Center Uniform Data Set: Montreal Cognitive Assessment; range: 0-30; higher scores indicate better performance

  2. Cognitive function: verbal working memory

    Time frame: 7 days

    National Alzheimer's Coordinating Center Uniform Data Set: Number Span Test Forward; number of correct trials, range: 0-14; higher scores indicate better performance

  3. Cognitive function: executive function

    Time frame: 7 days

    National Alzheimer's Coordinating Center Uniform Data Set: Number Span Test Backward; number of correct trials, range: 0-14; higher scores indicate better performance

  4. Cognitive function: set-shifting

    Time frame: 7 days

    National Alzheimer's Coordinating Center Uniform Data Set: Oral Trail Making Test; time in seconds, range: 0-300; higher scores indicate worse performance

  5. Circadian rhythm of continuous body temperature

    Time frame: 7 days

    Circadian rhythm: amplitude, acrophase, mesor via continuous body temperature obtained from wearable sensors

  6. Activity counts per minute

    Time frame: 7 days

    Daytime activity: activity counts per minute during daytime hours via wrist actigraphy

  7. Total sleep time in minutes

    Time frame: 7 days

    Nighttime sleep: total sleep time in minutes during nighttime hours via wrist actigraphy

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • American Association of Critical Care Nurses

Registry information

Acronym: OPTIMIZE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2022
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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