Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-05 @ 6:01 PM
Study NCT ID:
NCT01343095
Status:
TERMINATED
Last Update Posted:
2018-09-12
First Post:
2011-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Direct Noise Reduction in the Intensive Care Units (ICU) Using Earplugs and Noise Canceling Headphones
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D012892', 'term': 'Sleep Deprivation'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], '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': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mmiles@wakehealth.edu', 'phone': '336-716-7765', 'title': 'Matthew C. Miles', 'organization': 'Wake Forest Baptist Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'Usual Care between 10pm-6am', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Earplugs', 'description': 'Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.\n\nFoam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Earplugs and Headphones', 'description': 'Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.\n\nFoam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)\n\nNoise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Days Free of Delirium or Coma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual Care between 10pm-6am'}, {'id': 'OG001', 'title': 'Earplugs', 'description': 'Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.\n\nFoam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)'}, {'id': 'OG002', 'title': 'Earplugs and Headphones', 'description': 'Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.\n\nFoam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)\n\nNoise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the Study Period (Study Days 0-7 while patients were in ICU)', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Noise Attenuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual Care between 10pm-6am'}, {'id': 'OG001', 'title': 'Earplugs', 'description': 'Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.\n\nFoam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)'}, {'id': 'OG002', 'title': 'Earplugs and Headphones', 'description': 'Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.\n\nFoam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)\n\nNoise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies.'}], 'timeFrame': 'Overnight (10pm-6am) on study day 2 or 3.', 'description': 'The reduction in noise experienced by the subject when using the study intervention.', 'reportingStatus': 'POSTED', 'populationDescription': 'Devices were unable to measure noise above 85 dB(A) from the in-ear location; no noise data was collected.'}, {'type': 'SECONDARY', 'title': 'Sleep Efficiency and Architecture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual Care between 10pm-6am'}, {'id': 'OG001', 'title': 'Earplugs', 'description': 'Application of foam earplugs from 10pm-6am nightly for seven nights or until ICU discharge.\n\nFoam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)'}, {'id': 'OG002', 'title': 'Earplugs and Headphones', 'description': 'Foam Earplugs and Noise canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.\n\nFoam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)\n\nNoise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies.'}], 'timeFrame': 'Overnight (10pm-6am) on study day 2 or 3', 'description': 'Staging of sleep with efficiency determined as a ratio of total sleep time/total study time.', 'reportingStatus': 'POSTED', 'populationDescription': 'Sleep measurement equipment was not available for use during the study period'}, {'type': 'SECONDARY', 'title': 'Amount of Sedative Use (Midazolam and Lorazepam)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual Care between 10pm-6am'}, {'id': 'OG001', 'title': 'Earplugs', 'description': 'Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.\n\nFoam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)'}, {'id': 'OG002', 'title': 'Earplugs and Headphones', 'description': 'Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.\n\nFoam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)\n\nNoise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies.'}], 'classes': [{'title': 'Midazolam', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '10.65', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '79.5'}, {'value': '9.22', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '63.5'}]}]}, {'title': 'Lorazepam', 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '0.40', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6.5'}, {'value': '0.39', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the Study Period (Study Days 0-7)', 'unitOfMeasure': 'mg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Amount of Analgesic Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual Care between 10pm-6am'}, {'id': 'OG001', 'title': 'Earplugs', 'description': 'Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.\n\nFoam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)'}, {'id': 'OG002', 'title': 'Earplugs and Headphones', 'description': 'Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.\n\nFoam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)\n\nNoise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies.'}], 'classes': [{'title': 'Fentanyl', 'categories': [{'measurements': [{'value': '0.29', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.55'}, {'value': '0.37', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2.425'}, {'value': '0.32', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2.575'}]}]}, {'title': 'Morphine', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0.03', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '1.5'}]}]}, {'title': 'Dilaudid', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0.07', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Hydrocodone', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0.18', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the Study Period (Study Days 0-7)', 'description': 'Mean of analgesic daily use', 'unitOfMeasure': 'mg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Amount of Sedative Use (Propofol and Demedetomidine )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual Care between 10pm-6am'}, {'id': 'OG001', 'title': 'Earplugs', 'description': 'Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.\n\nFoam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)'}, {'id': 'OG002', 'title': 'Earplugs and Headphones', 'description': 'Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.\n\nFoam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)\n\nNoise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies.'}], 'classes': [{'title': 'Propofol', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Demedetomidine', 'categories': [{'measurements': [{'value': '1.36', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '13.6'}, {'value': '0.98', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '9.9'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the Study Period (Study Days 0-7)', 'description': 'Mean of sedative daily use (Propofol and Demedetomidine )', 'unitOfMeasure': 'mcg/kg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'Usual Care between 10pm-6am'}, {'id': 'FG001', 'title': 'Earplugs', 'description': 'Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.\n\nFoam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)'}, {'id': 'FG002', 'title': 'Earplugs and Headphones', 'description': 'Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.\n\nFoam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)\n\nNoise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'Usual Care between 10pm-6am'}, {'id': 'BG001', 'title': 'Earplugs', 'description': 'Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.\n\nFoam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)'}, {'id': 'BG002', 'title': 'Earplugs and Headphones', 'description': 'Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.\n\nFoam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)\n\nNoise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000', 'lowerLimit': '71', 'upperLimit': '73'}, {'value': '66', 'groupId': 'BG001', 'lowerLimit': '53', 'upperLimit': '71'}, {'value': '56', 'groupId': 'BG002', 'lowerLimit': '40', 'upperLimit': '77'}, {'value': '63', 'groupId': 'BG003', 'lowerLimit': '40', 'upperLimit': '77'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Mean SAPS II', 'classes': [{'categories': [{'measurements': [{'value': '57.5', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '88'}, {'value': '40', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '68'}, {'value': '57.6', 'groupId': 'BG002', 'lowerLimit': '43', 'upperLimit': '74'}, {'value': '51', 'groupId': 'BG003', 'lowerLimit': '22', 'upperLimit': '88'}]}]}], 'paramType': 'MEAN', 'description': 'Severe Acute Physiology Scale II. The SAPS II score is made of 12 physiological variables and 3 disease-related variables. The worst physiological variables were collected within the first 24 hours of ICU admission. The "worst" measurement was defined as the measure that correlated to the highest number of points. The study did not continually calculate SAPS II scores beyond the first 24 hours of ICU admission. The SAPS II score ranges from 0 to 163 points.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Loss of study staff', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2011-04-13', 'resultsFirstSubmitDate': '2016-05-03', 'studyFirstSubmitQcDate': '2011-04-26', 'lastUpdatePostDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-21', 'studyFirstPostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days Free of Delirium or Coma', 'timeFrame': 'During the Study Period (Study Days 0-7 while patients were in ICU)'}], 'secondaryOutcomes': [{'measure': 'Noise Attenuation', 'timeFrame': 'Overnight (10pm-6am) on study day 2 or 3.', 'description': 'The reduction in noise experienced by the subject when using the study intervention.'}, {'measure': 'Sleep Efficiency and Architecture', 'timeFrame': 'Overnight (10pm-6am) on study day 2 or 3', 'description': 'Staging of sleep with efficiency determined as a ratio of total sleep time/total study time.'}, {'measure': 'Amount of Sedative Use (Midazolam and Lorazepam)', 'timeFrame': 'During the Study Period (Study Days 0-7)'}, {'measure': 'Amount of Analgesic Use', 'timeFrame': 'During the Study Period (Study Days 0-7)', 'description': 'Mean of analgesic daily use'}, {'measure': 'Amount of Sedative Use (Propofol and Demedetomidine )', 'timeFrame': 'During the Study Period (Study Days 0-7)', 'description': 'Mean of sedative daily use (Propofol and Demedetomidine )'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ICU Delirium', 'Delirium', 'Sleep Quality', 'Sleep Efficiency', 'ICU Noise', 'Noise Reduction', 'Earplugs', 'Noise Canceling Headphones'], 'conditions': ['Delirium', 'Sleep Fragmentation']}, 'descriptionModule': {'briefSummary': 'This study seeks to examine the effects of overnight noise reduction in critically ill patients who are receiving mechanical ventilation. The investigators will randomly place subjects into one of three groups: 1) usual care 2) overnight earplugs 3) overnight earplugs and noise-canceling headphones. The investigators will monitor for safety, and will measure the amount of delirium experienced by subjects, record the amount of sedating and painkilling medicines required, and measure sleep quality during the study, among other information. The investigators will also measure noise levels experienced by patients in each group. The investigators predict that the use of overnight noise reduction will be safe and will reduce the amount of delirium by improving the quality of sleep in critically ill patients.', 'detailedDescription': 'Delirium is an acute confusional state defined by fluctuating mental status, inattention, and either disorganized thinking or an altered level of consciousness. Acute delirium is an increasingly recognized problem in intensive care units (ICUs) in the US and worldwide. ICU Delirium has been estimated to occur in as many as 50 to 80 percent of ICU patients. Delirium in the ICU has been associated with worsened clinical outcomes such as prolonged hospitalization and death \\[1-4\\]. Although noise has been shown to negatively influence sleep in the ICU, and sleep disturbance is a recognized contributor to ICU delirium\\[1-2, 4\\], there is no well-established link between ICU noise levels and the development of ICU delirium. Optimal strategies for the prevention and treatment of ICU delirium are yet to be defined, and this study will focus on a novel noise-reduction approach which has potential to impact both prevention and treatment \\[5-8\\]. Findings will be generalizable to other tertiary care medical intensive care units caring for adult patients.\n\nObjectives Our multidisciplinary team will evaluate the safety and feasibility of direct noise reduction in the Wake Forest University Baptist Medical Center (WFUBMC) Medical Intensive Care Unit (MICU), and any effect on the incidence of ICU delirium.\n\nMethods and Measures Design\n\n* Forty-five (45) patients receiving mechanical ventilation will be randomized to receive either passive direct noise reduction (earplugs), both passive and active direct noise reduction (earplugs and noise-canceling headphones), or no direct noise reduction (usual practice).\n* Ambient noise levels and the reduction in noise accomplished by direct noise reduction will be measured according to standardized audiometric techniques.\n* Sleep structure, including amount of recovery sleep, will be measured over one night according to standardized polysomnographic (sleep study) techniques\n* The incidence of delirium will be assessed as well as multiple other endpoints including but not limited to amount of psychoactive medication prescribed and amount of physical restraints required.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients who are admitted to our MICU for at least 24 hours with at least 72 hours' additional expected stay in ICU, and who are mechanically ventilated\n\nExclusion Criteria:\n\n* severe to profound hearing loss\n* baseline use of hearing aids\n* eardrum perforation\n* severe cerumen impaction\n* head or oromaxillofacial trauma\n* external ventricular drain or intracranial pressure monitoring devices\n* comatose patients who are deemed by their attending physician as unlikely to awaken within 72 hours\n* patient status as comfort-measures only\n* any other contraindication to the use of earplugs or headphones"}, 'identificationModule': {'nctId': 'NCT01343095', 'briefTitle': 'Direct Noise Reduction in the Intensive Care Units (ICU) Using Earplugs and Noise Canceling Headphones', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Randomized Controlled Trial of Direct Noise Reduction in the ICU Using Overnight Application of In-ear Earplugs or In-ear Earplugs Plus Noise-Canceling Headphones to Reduce the Incidence and Duration of ICU Delirium', 'orgStudyIdInfo': {'id': 'IRB00013140'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Usual Care between 10pm-6am'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Earplugs', 'description': 'Application of foam earplugs from 10pm-6am nightly for seven nights or until ICU discharge.', 'interventionNames': ['Device: Foam Earplugs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Earplugs and Headphones', 'description': 'Foam Earplugs and Noise canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.', 'interventionNames': ['Device: Foam Earplugs', 'Device: Noise Canceling Headphones']}], 'interventions': [{'name': 'Foam Earplugs', 'type': 'DEVICE', 'description': 'Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)', 'armGroupLabels': ['Earplugs', 'Earplugs and Headphones']}, {'name': 'Noise Canceling Headphones', 'type': 'DEVICE', 'description': 'Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies.', 'armGroupLabels': ['Earplugs and Headphones']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Matthew C Miles, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'de-identified data was shared with another investigator as part of a review and meta-analysis'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}