Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2026-02-25 @ 4:48 PM
Study NCT ID:
NCT06411561
Status:
RECRUITING
Last Update Posted:
2025-07-20
First Post:
2024-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012890', 'term': 'Sleep'}], 'ancestors': [{'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2024-04-11', 'studyFirstSubmitQcDate': '2024-05-07', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive function', 'timeFrame': 'Post-intervention/within 7 days of hospital discharge', 'description': 'RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance'}, {'measure': 'Cognitive function', 'timeFrame': 'Follow-up at 1 month post-hospital discharge', 'description': 'RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance'}, {'measure': 'Cognitive function', 'timeFrame': 'Follow-up at 6 months post-hospital discharge', 'description': 'RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance'}, {'measure': 'Cognitive function', 'timeFrame': 'Follow-up at 12 months post-hospital discharge', 'description': 'RBANS Update: Repeatable Battery for the Assessment of Neuropsychological Status; total index score, range: 40-160; higher scores indicate better performance'}], 'secondaryOutcomes': [{'measure': 'Cognitive function: executive function, working memory', 'timeFrame': 'Post-intervention/within 7 days of hospital discharge', 'description': 'Wechsler Adult Intelligence Scale-III Digit Span Test-Backward; number of correct trials, range: 0-14; higher scores indicate better performance'}, {'measure': 'Cognitive function: executive function, working memory', 'timeFrame': 'Follow-up at 1 month post-hospital discharge', 'description': 'Wechsler Adult Intelligence Scale-III Digit Span Test-Backward; number of correct trials, range: 0-14; higher scores indicate better performance'}, {'measure': 'Cognitive function: executive function, working memory', 'timeFrame': 'Follow-up at 6 months post-hospital discharge', 'description': 'Wechsler Adult Intelligence Scale-III Digit Span Test-Backward; number of correct trials, range: 0-14; higher scores indicate better performance'}, {'measure': 'Cognitive function: executive function, working memory', 'timeFrame': 'Follow-up at 12 months post-hospital discharge', 'description': 'Wechsler Adult Intelligence Scale-III Digit Span Test-Backward; number of correct trials, range: 0-14; higher scores indicate better performance'}, {'measure': 'Cognitive function: executive function, set-shifting', 'timeFrame': 'Post-intervention/within 7 days of hospital discharge', 'description': "National Alzheimer's Coordinating Center Uniform Data Set: Oral Trail Making Test; time in seconds, range: 0-300; higher scores indicate worse performance"}, {'measure': 'Cognitive function: executive function, set-shifting', 'timeFrame': 'Follow-up at 1 month post-hospital discharge', 'description': "National Alzheimer's Coordinating Center Uniform Data Set: Oral Trail Making Test; time in seconds, range: 0-300; higher scores indicate worse performance"}, {'measure': 'Cognitive function: executive function, set-shifting', 'timeFrame': 'Follow-up at 6 months post-hospital discharge', 'description': "National Alzheimer's Coordinating Center Uniform Data Set: Oral Trail Making Test; time in seconds, range: 0-300; higher scores indicate worse performance"}, {'measure': 'Cognitive function: executive function, set-shifting', 'timeFrame': 'Follow-up at 12 months post-hospital discharge', 'description': "National Alzheimer's Coordinating Center Uniform Data Set: Oral Trail Making Test; time in seconds, range: 0-300; higher scores indicate worse performance"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critical Illness', 'Delirium', 'Cognitive Impairment', 'Cognitive Decline', "Alzheimer's Disease", 'Dementia', 'Circadian Dysrhythmia', 'Sleep Disturbance']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nSpecific 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.\n\nSpecific Aim 2: Examine circadian rhythm parameters of continuous body temperature (iButton: wearable sensor) to determine the optimal window for timing of the COG intervention.\n\nSpecific 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.\n\nExploratory 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age greater than or equal to 60 years old\n* Current hospitalization at University of Washington Medical Center or Harborview Medical Center\n* Intensive care unit (ICU) length of stay greater than 24 hours\n* Recovery from critical care status to acute care status, and/or discharge out of ICU\n* Fluent in English or Spanish\n* Functional independence on activities of daily living prior to hospitalization (Katz Index = 6)\n\nExclusion Criteria:\n\n* Documented history or suspicion of Alzheimer's disease or dementia, or current prescription of anti-dementia medication\n* Documented history of bipolar disorder or schizophrenia\n* Documented acute stroke or traumatic brain injury\n* Severe vision impairment\n* Severe hearing impairment\n* Severe paralysis or dominant arm paresis\n* Transfer from skilled nursing care facility or inpatient rehabilitation facility"}, 'identificationModule': {'nctId': 'NCT06411561', 'acronym': 'SLEEP-COG', 'briefTitle': 'A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors', 'orgStudyIdInfo': {'id': 'STUDY00018228'}, 'secondaryIdInfos': [{'id': 'K23AG078448', 'link': 'https://reporter.nih.gov/quickSearch/K23AG078448', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SLEEP + COG', 'description': '* Combination of SLEEP and COG interventions, for up to 7 days/nights + usual post-ICU inpatient care\n* Personalized timing of morning, afternoon, or evening COG sessions, based on CSM scale at baseline', 'interventionNames': ['Behavioral: SLEEP + COG']}, {'type': 'EXPERIMENTAL', 'label': 'COG', 'description': '* Daily 30-minute computerized cognitive training sessions (Lumosity), for up to 7 days + usual post-ICU inpatient care\n* Personalized timing of morning, afternoon, or evening COG intervention sessions, based on CSM scale at baseline', 'interventionNames': ['Behavioral: COG']}, {'type': 'EXPERIMENTAL', 'label': 'SLEEP', 'description': '\\- Nighttime use of earplugs and eye masks, for up to 7 nights + usual post-ICU inpatient care', 'interventionNames': ['Behavioral: SLEEP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AC', 'description': '\\- Active comparator condition; delivery of educational modules on brain health + usual post-ICU inpatient care', 'interventionNames': ['Behavioral: AC']}], 'interventions': [{'name': 'SLEEP + COG', 'type': 'BEHAVIORAL', 'description': 'Combination of SLEEP and COG interventions', 'armGroupLabels': ['SLEEP + COG']}, {'name': 'COG', 'type': 'BEHAVIORAL', 'description': 'Daily 30-minute session of computerized cognitive training', 'armGroupLabels': ['COG']}, {'name': 'SLEEP', 'type': 'BEHAVIORAL', 'description': 'Nighttime use of both ear plugs and eye masks', 'armGroupLabels': ['SLEEP']}, {'name': 'AC', 'type': 'BEHAVIORAL', 'description': 'Educational modules on cognitive and sleep health', 'armGroupLabels': ['AC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maya N Elias, PhD, MA, RN', 'role': 'CONTACT', 'email': 'mnelias@uw.edu'}], 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Maya N Elias, PhD, MA, RN', 'role': 'CONTACT', 'email': 'mnelias@uw.edu', 'phone': '206-543-8564'}], 'overallOfficials': [{'name': 'Maya N Elias, PhD, MA, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, School of Nursing', 'investigatorFullName': 'Maya Elias, PhD, RN', 'investigatorAffiliation': 'University of Washington'}}}}