Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT03471520
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2018-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Earplugs and Eye Masks for Reducing Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}], 'ancestors': [{'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': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004430', 'term': 'Ear Protective Devices'}], 'ancestors': [{'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D011481', 'term': 'Protective Clothing'}, {'id': 'D003020', 'term': 'Clothing'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2018-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-03', 'studyFirstSubmitDate': '2018-03-14', 'studyFirstSubmitQcDate': '2018-03-14', 'lastUpdatePostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of delirium', 'timeFrame': "The first 5 days of patients' hospitalization", 'description': 'Will be assessed using the CAM'}, {'measure': 'Feasibility as measured by number of patients screened', 'timeFrame': '5 days'}, {'measure': 'Feasibility as measured by number of patients ineligible', 'timeFrame': '5 days'}, {'measure': 'Feasibility as measured by number of patients who decline to participate', 'timeFrame': '5 days'}, {'measure': 'Feasibility as measured by number of patients who dropped out of the study', 'timeFrame': '5 days'}, {'measure': 'Feasibility as measured by number of patients who wore the earplugs', 'timeFrame': '5 days'}, {'measure': 'Feasibility as measured by number of patients who wore the eye masks', 'timeFrame': '5 days'}, {'measure': 'Feasibility as measured by number of CAM assessment days', 'timeFrame': '5 days'}, {'measure': 'Feasibility as measured by number of patients who successfully completed the study', 'timeFrame': '5 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Delirium', 'Hospital Acquired Condition']}, 'descriptionModule': {'briefSummary': 'There has been some recent evidence to support the use of earplugs and eye masks to prevent delirium, but the existing studies have been small, have not been thoroughly replicated, and have only been conducted with intensive care unit (ICU) patients. Therefore, we propose to conduct a single-arm pilot study for an eventual single-blinded randomized controlled trial designed to assess the efficacy of earplugs and eye masks worn at night for prevention of delirium in a population of general medicine inpatients over the age of 65. The primary outcome will be incidence of delirium as measured by Confusion Assessment Method (CAM). In this pilot study, we will assess feasibility and will not perform any statistical comparisons. In the subsequent randomized controlled trial, we will be comparing the hazard rates on an intention-to-treat basis. Secondary outcomes will be exploratory and include length of stay, cost data, and use of pharmacologic interventions for sleep, delirium, or agitation. There are no physical risks and no cost to the subjects in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to General Medicine (units 8100 and 8300 only) from the Duke University Hospital (DUH) Emergency Department\n* Age \\>= 65\n\nExclusion Criteria:\n\n* Admitted from outside hospitals, clinics (i.e., direct admissions), or transferred from another department\n* Admitted as "observation" (i.e., expected length of stay \\< 2 nights)\n* Admitted \\> 24 hours prior to time of enrollment\n* Non-English-speaking patients will be excluded because a language barrier would introduce inaccuracy into the CAM measurement and for feasibility reasons (e.g., availability of translator services)\n* Blind or deaf patients will be excluded because they are unlikely to benefit from the intervention, but sensory-impaired patients will be included\n* Patients lacking decision-making capacity for whom no Legally Authorized Representative (LAR) is available\n* Primary reason for admission "altered mental status", drug withdrawal, stroke, or seizure\n* Patients for whom a withdrawal pathway has been preemptively initiated based on their substance use history (e.g., the alcohol withdrawal pathway order set or other as needed ("PRN") orders for the indication of withdrawal)\n* Delirium present at time of enrollment\n* Glasgow Coma Scale (GCS) \\< 10 at time of enrollment\n* Enrolled in this trial during a previous admission (i.e., we will not resample)\n* Enrolled in a separate trial this admission\n* Contraindication to using earplugs or an eye mask (e.g., facial trauma or other safety concern)\n* Significant fall risk per nursing assessment'}, 'identificationModule': {'nctId': 'NCT03471520', 'briefTitle': 'Earplugs and Eye Masks for Reducing Delirium', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Earplugs and Eye Masks Worn at Night to Reduce the Incidence of Delirium in General Medicine Inpatients', 'orgStudyIdInfo': {'id': 'Pro00087770'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Earplugs and eye masks', 'interventionNames': ['Behavioral: Earplugs and eye masks']}], 'interventions': [{'name': 'Earplugs and eye masks', 'type': 'BEHAVIORAL', 'description': 'Patients in this study will be given earplugs and eye masks to be worn during sleep', 'armGroupLabels': ['Earplugs and eye masks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Health System', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Juliessa Pavon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}