Critical IllnessOPTIMIZENCT05467410
Optimal Timing of Computerized Cognitive Training for Older Intensive Care Unit Survivors
A study testing COG-AM and COG-PM in people with Critical Illness and Cognitive Impairment, run by University of Washington at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Critical Illness, Cognitive Impairment, Circadian Dysrhythmia
- What is being tested?
- COG-AM and COG-PM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Nov 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Harborview Medical Center
Seattle, Washington, 98104
University of Washington Medical Center
Seattle, Washington, 98195
About this study
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.
Read the detailed description
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.
- Conditions
- Critical Illness, Cognitive Impairment, Circadian Dysrhythmia, Intensive Care Unit Delirium, Aging, Older People
- Being tested
- COG-AM, COG-PM
- Medical subject headings
- Critical Illness, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COG-AMBehavioural
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-PMBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| COG-AM | Experimental | 30-minute morning session of a laptop-based computerized cognitive training intervention, delivered between the hours of 09:00 AM - 12:00 PM, in addition to UC Receives: Behavioral: COG-AM |
| COG-PM | Experimental | 30-minute afternoon/evening session of a laptop-based computerized cognitive training intervention, delivered between the hours of 15:00 PM - 18:00 PM, in addition to UC Receives: Behavioral: COG-PM |
| UC | No intervention | Standard post-ICU inpatient care/usual care, which includes physical/occupational therapy as ordered by treatment team |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of morning-only sessions of computerized cognitive training
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]).
Measured: 7 days
Feasibility of afternoon/evening-only sessions of computerized cognitive training
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]).
Measured: 7 days
Acceptability of morning-only sessions of computerized cognitive training
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.
Measured: 7 days
Acceptability of afternoon/evening-only sessions of computerized cognitive training
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.
Measured: 7 days
Secondary outcomes (7)
Cognitive function: global cognition
National Alzheimer's Coordinating Center Uniform Data Set: Montreal Cognitive Assessment; range: 0-30; higher scores indicate better performance
Measured: 7 days
Cognitive function: verbal working memory
National Alzheimer's Coordinating Center Uniform Data Set: Number Span Test Forward; number of correct trials, range: 0-14; higher scores indicate better performance
Measured: 7 days
Cognitive function: executive function
National Alzheimer's Coordinating Center Uniform Data Set: Number Span Test Backward; number of correct trials, range: 0-14; higher scores indicate better performance
Measured: 7 days
Cognitive function: set-shifting
National Alzheimer's Coordinating Center Uniform Data Set: Oral Trail Making Test; time in seconds, range: 0-300; higher scores indicate worse performance
Measured: 7 days
Circadian rhythm of continuous body temperature
Circadian rhythm: amplitude, acrophase, mesor via continuous body temperature obtained from wearable sensors
Measured: 7 days
Activity counts per minute
Daytime activity: activity counts per minute during daytime hours via wrist actigraphy
Measured: 7 days
Total sleep time in minutes
Nighttime sleep: total sleep time in minutes during nighttime hours via wrist actigraphy
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start15 Nov 2023
- Primary completion2 Feb 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, experimental design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- American Association of Critical Care Nurses
- Responsible party
- Principal investigator, Maya Elias, PhD, RN, University of Washington
- Investigators
- Maya N Elias, PhD, MA, RN, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467410
- Sponsor's protocol ID
- STUDY00014922
- Other IDs
- 40067
- Acronym
- OPTIMIZE
- Status last verified
- Feb 2026
- First submitted
- 21 Apr 2022
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Timing of Computerized Cognitive Training for Older Intensive Care Unit Survivors
- ClinicalTrials.gov ID
- NCT05467410
- Acronym / sponsor ID
- OPTIMIZE / STUDY00014922
- Conditions
- Critical Illness, Cognitive Impairment, Circadian Dysrhythmia, Intensive Care Unit Delirium, Aging, Older People
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- American Association of Critical Care Nurses
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, randomized, experimental design
| Arm | Type | Receives |
|---|---|---|
| COG-AM | Experimental | Behavioral: COG-AM30-minute morning session of a laptop-based computerized cognitive training intervention, delivered between the hours of 09:00 AM - 12:00 PM, in addition to UC |
| COG-PM | Experimental | Behavioral: COG-PM30-minute afternoon/evening session of a laptop-based computerized cognitive training intervention, delivered between the hours of 15:00 PM - 18:00 PM, in addition to UC |
| UC | No intervention | –Standard post-ICU inpatient care/usual care, which includes physical/occupational therapy as ordered by treatment team |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COG-AMParticipants 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. | Behavioural | COG-AM |
| COG-PMParticipants 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. | Behavioural | COG-PM |
Primary outcome
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]).
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]).
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.
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.
7 secondary outcomes
Cognitive function: global cognition
Time frame: 7 days
Cognitive function: verbal working memory
Time frame: 7 days
Cognitive function: executive function
Time frame: 7 days
Cognitive function: set-shifting
Time frame: 7 days
Circadian rhythm of continuous body temperature
Time frame: 7 days
Activity counts per minute
Time frame: 7 days
Total sleep time in minutes
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maya N Elias, PhD, MA, RN principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COG-AM and COG-PM in people with Critical Illness and Cognitive Impairment, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of morning-only sessions of computerized cognitive training (time frame: 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.