Critical IllnessSLEEP-COGNCT06411561
A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors
A study testing SLEEP + COG, COG and SLEEP in people with Critical Illness and Delirium, run by University of Washington at 1 site in United States.
Trial summary
Up to 25% of intensive care unit (ICU) survivors experience cognitive impairment comparable in severity to mild Alzheimer's disease and related dementias after hospital discharge. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Critical Illness, Delirium, Cognitive Impairment
- What is being tested?
- SLEEP + COG, COG and SLEEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Dec 2024to 31 May 2027
- 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 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Maya N Elias, PhD, MA, RN, mnelias@uw.edu
About this study
Up to 25% of intensive care unit (ICU) survivors experience cognitive impairment comparable in severity to mild Alzheimer's disease and related dementias after hospital discharge. Older ICU survivors (ages 60 and older) are at highest risk for delirium and subsequent cognitive impairment, which contribute to higher risk for cognitive decline related to Alzheimer's disease and related dementias. Sleep and activity are essential for recovery from critical illness, yet ICU survivors experience both sleep deficiency and profound inactivity. About 75-80% of ICU patients experience circadian dysrhythmia, which contributes to cognitive decline and increases likelihood of developing Alzheimer's disease and related dementias. The scientific premises of the proposed study are: 1) a combined sleep promotion and cognitive training intervention will have synergistic effects to mitigate the risk of cognitive impairment and development of Alzheimer's disease and related dementias in older ICU survivors; and 2) chronotherapeutic timing of interventions (i.e., adjusting timing of interventions according to circadian rhythm) may improve intervention efficacy.
Read the detailed description
Using a 2 x 2 factorial design, 100 English- or Spanish-speaking older ICU survivors will be enrolled after discharge out of ICU and randomized to one of 4 combinations of two interventions: SLEEP and COG. We propose that the combination of a nighttime sleep promotion intervention [SLEEP: nighttime use of earplugs and eye masks] and a daytime computerized cognitive training intervention [COG: daily 30-minute cognitive training sessions] may produce synergistic effects on cognitive function to mitigate delirium and reduce risk of incident Alzheimer's disease and related dementias. Because circadian dysrhythmia contributes to cognitive decline, chronotherapeutic timing of the COG intervention could maximize intervention efficacy.
Specific Aim 1: Test the separate and combined effects of SLEEP and COG [SLEEP + COG, SLEEP, COG] versus an active control [AC] in improving cognitive function for older ICU survivors.
Specific Aim 2: Examine circadian rhythm parameters of continuous body temperature (iButton: wearable sensor) to determine the optimal window for timing of the COG intervention.
Specific Aim 3: Examine if the effects of each intervention on cognitive function are mediated by sleep and activity, and examine if selected biological and clinical factors moderate intervention effects.
Exploratory Aim 4: Explore the effect of each intervention on cognitive function at 1 month and incident Alzheimer's disease and related dementias at 6 months and 12 months post-hospital discharge.
- Conditions
- Critical Illness, Delirium, Cognitive Impairment, Cognitive Decline, Alzheimer's Disease, Dementia
- Being tested
- SLEEP + COG, COG, SLEEP, AC
- Medical subject headings
- Critical Illness, Delirium, Cognitive Dysfunction, Alzheimer Disease, Dementia, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLEEP + COGBehavioural
Combination of SLEEP and COG interventions
COGBehavioural
Daily 30-minute session of computerized cognitive training
SLEEPBehavioural
Nighttime use of both ear plugs and eye masks
ACBehavioural
Educational modules on cognitive and sleep health
| Study group | Role | What they receive |
|---|---|---|
| SLEEP + COG | Experimental | * Combination of SLEEP and COG interventions, for up to 7 days/nights + usual post-ICU inpatient care
* Personalized timing of morning, afternoon, or evening COG sessions, based on CSM scale at baseline Receives: Behavioral: SLEEP + COG |
| COG | Experimental | * Daily 30-minute computerized cognitive training sessions (Lumosity), for up to 7 days + usual post-ICU inpatient care
* Personalized timing of morning, afternoon, or evening COG intervention sessions, based on CSM scale at baseline Receives: Behavioral: COG |
| SLEEP | Experimental | - Nighttime use of earplugs and eye masks, for up to 7 nights + usual post-ICU inpatient care Receives: Behavioral: SLEEP |
| AC | Active comparator | - Active comparator condition; delivery of educational modules on brain health + usual post-ICU inpatient care Receives: Behavioral: AC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Measured: Post-intervention/within 7 days of hospital discharge
Cognitive function
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Measured: Follow-up at 1 month post-hospital discharge
Cognitive function
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Measured: Follow-up at 6 months post-hospital discharge
Cognitive function
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Measured: Follow-up at 12 months post-hospital discharge
Secondary outcomes (8)
Cognitive function: executive function, working memory
Wechsler Adult Intelligence Scale-III Digit Span Test-Backward; number of correct trials, range: 0-14; higher scores indicate better performance
Measured: Post-intervention/within 7 days of hospital discharge
Cognitive function: executive function, working memory
Wechsler Adult Intelligence Scale-III Digit Span Test-Backward; number of correct trials, range: 0-14; higher scores indicate better performance
Measured: Follow-up at 1 month post-hospital discharge
Cognitive function: executive function, working memory
Wechsler Adult Intelligence Scale-III Digit Span Test-Backward; number of correct trials, range: 0-14; higher scores indicate better performance
Measured: Follow-up at 6 months post-hospital discharge
Cognitive function: executive function, working memory
Wechsler Adult Intelligence Scale-III Digit Span Test-Backward; number of correct trials, range: 0-14; higher scores indicate better performance
Measured: Follow-up at 12 months post-hospital discharge
Cognitive function: executive 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: Post-intervention/within 7 days of hospital discharge
Cognitive function: executive 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: Follow-up at 1 month post-hospital discharge
Cognitive function: executive 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: Follow-up at 6 months post-hospital discharge
Cognitive function: executive 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: Follow-up at 12 months post-hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start26 Dec 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- 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
- NCT06411561
- Sponsor's protocol ID
- STUDY00018228
- Other IDs
- K23AG078448
- Acronym
- SLEEP-COG
- Status last verified
- Jul 2025
- First submitted
- 11 Apr 2024
- Last updated
- 20 Jul 2025
- 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 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors
- ClinicalTrials.gov ID
- NCT06411561
- Acronym / sponsor ID
- SLEEP-COG / STUDY00018228
- Conditions
- Critical Illness, Delirium, Cognitive Impairment, Cognitive Decline, Alzheimer's Disease, Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 13 May 2024 (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.
Up to 25% of intensive care unit (ICU) survivors experience cognitive impairment comparable in severity to mild Alzheimer's disease and related dementias after hospital discharge. Older ICU survivors (ages 60 and older) are at highest risk for delirium and subsequent cognitive impairment, which contribute to higher risk for cognitive decline related to Alzheimer's disease and related dementias. Sleep and activity are essential for recovery from critical illness, yet ICU survivors experience both sleep deficiency and profound inactivity. About 75-80% of ICU patients experience circadian dysrhythmia, which contributes to cognitive decline and increases likelihood of developing Alzheimer's disease and related dementias. The scientific premises of the proposed study are: 1) a combined sleep promotion and cognitive training intervention will have synergistic effects to mitigate the risk of cognitive impairment and development of Alzheimer's disease and related dementias in older ICU survivors; and 2) chronotherapeutic timing of interventions (i.e., adjusting timing of interventions according to circadian rhythm) may improve intervention efficacy.
Detailed description
Using a 2 x 2 factorial design, 100 English- or Spanish-speaking older ICU survivors will be enrolled after discharge out of ICU and randomized to one of 4 combinations of two interventions: SLEEP and COG. We propose that the combination of a nighttime sleep promotion intervention [SLEEP: nighttime use of earplugs and eye masks] and a daytime computerized cognitive training intervention [COG: daily 30-minute cognitive training sessions] may produce synergistic effects on cognitive function to mitigate delirium and reduce risk of incident Alzheimer's disease and related dementias. Because circadian dysrhythmia contributes to cognitive decline, chronotherapeutic timing of the COG intervention could maximize intervention efficacy.
Specific Aim 1: Test the separate and combined effects of SLEEP and COG [SLEEP + COG, SLEEP, COG] versus an active control [AC] in improving cognitive function for older ICU survivors.
Specific Aim 2: Examine circadian rhythm parameters of continuous body temperature (iButton: wearable sensor) to determine the optimal window for timing of the COG intervention.
Specific Aim 3: Examine if the effects of each intervention on cognitive function are mediated by sleep and activity, and examine if selected biological and clinical factors moderate intervention effects.
Exploratory Aim 4: Explore the effect of each intervention on cognitive function at 1 month and incident Alzheimer's disease and related dementias at 6 months and 12 months post-hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SLEEP + COG | Experimental | Behavioral: SLEEP + COG* Combination of SLEEP and COG interventions, for up to 7 days/nights + usual post-ICU inpatient care * Personalized timing of morning, afternoon, or evening COG sessions, based on CSM scale at baseline |
| COG | Experimental | Behavioral: COG* Daily 30-minute computerized cognitive training sessions (Lumosity), for up to 7 days + usual post-ICU inpatient care * Personalized timing of morning, afternoon, or evening COG intervention sessions, based on CSM scale at baseline |
| SLEEP | Experimental | Behavioral: SLEEP- Nighttime use of earplugs and eye masks, for up to 7 nights + usual post-ICU inpatient care |
| AC | Active comparator | Behavioral: AC- Active comparator condition; delivery of educational modules on brain health + usual post-ICU inpatient care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| SLEEP + COGCombination of SLEEP and COG interventions | Behavioural | SLEEP + COG |
| COGDaily 30-minute session of computerized cognitive training | Behavioural | COG |
| SLEEPNighttime use of both ear plugs and eye masks | Behavioural | SLEEP |
| ACEducational modules on cognitive and sleep health | Behavioural | AC |
Primary outcome
Cognitive function
Time frame: Post-intervention/within 7 days of hospital discharge
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Cognitive function
Time frame: Follow-up at 1 month post-hospital discharge
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Cognitive function
Time frame: Follow-up at 6 months post-hospital discharge
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
Cognitive function
Time frame: Follow-up at 12 months post-hospital discharge
RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance
8 secondary outcomes
Cognitive function: executive function, working memory
Time frame: Post-intervention/within 7 days of hospital discharge
Cognitive function: executive function, working memory
Time frame: Follow-up at 1 month post-hospital discharge
Cognitive function: executive function, working memory
Time frame: Follow-up at 6 months post-hospital discharge
Cognitive function: executive function, working memory
Time frame: Follow-up at 12 months post-hospital discharge
Cognitive function: executive function, set-shifting
Time frame: Post-intervention/within 7 days of hospital discharge
Cognitive function: executive function, set-shifting
Time frame: Follow-up at 1 month post-hospital discharge
Cognitive function: executive function, set-shifting
Time frame: Follow-up at 6 months post-hospital discharge
Cognitive function: executive function, set-shifting
Time frame: Follow-up at 12 months post-hospital discharge
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 20 Jul 2025.
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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.
Maya N Elias, PhD, MA, RN principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLEEP + COG, COG and SLEEP in people with Critical Illness and Delirium, run by University of Washington at 1 site 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 6 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: looking for participants now, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Maya N Elias, PhD, MA, RN (206-543-8564, mnelias@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: Post-intervention/within 7 days of hospital discharge). 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 20 Jul 2025.