Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-04-17 @ 2:40 AM
Study NCT ID:
NCT02292134
Status:
COMPLETED
Last Update Posted:
2014-11-17
First Post:
2013-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Sleep Quality in ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-14', 'studyFirstSubmitDate': '2013-11-21', 'studyFirstSubmitQcDate': '2014-11-14', 'lastUpdatePostDateStruct': {'date': '2014-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of sleep stage 3 and 4 (polysomnography)', 'timeFrame': 'day 2', 'description': 'Significant change of the duration of sleep stage 3 and 4 (polysomnography) in the "protective strategy group" (earplug and sleep mask) as compared to the control group (conventional strategy).'}], 'secondaryOutcomes': [{'measure': 'Nocturnal awakenings (polysomnography)', 'timeFrame': 'Day 2', 'description': 'in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).'}, {'measure': 'Proportion of REM sleep (polysomnography)', 'timeFrame': 'Day 2', 'description': 'in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).'}, {'measure': 'Total sleep time (polysomnography)', 'timeFrame': 'Day 2', 'description': 'in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).'}, {'measure': 'Sleep time efficiency (polysomnography)', 'timeFrame': 'Day 2', 'description': 'in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).'}, {'measure': 'level of anxiety and depression (HAD scale)', 'timeFrame': 'At ICU discharge, an expected average of 3 weeks', 'description': 'participants will be followed for the duration of ICU stay, a expected average of 3 weeks. comparison between the "protective strategy group" (earplug and sleep mask) and the control group (conventional strategy).'}, {'measure': 'level of anxiety and depression (HAD scale)', 'timeFrame': 'At day 90', 'description': 'comparison between the "protective strategy group" (earplug and sleep mask) and the control group (conventional strategy).'}, {'measure': 'Incidence of posttraumatic stress disorder syndrome', 'timeFrame': 'At ICU discharge, an expected average of 3 weeks', 'description': 'participants will be followed for the duration of ICU stay, a expected average of 3 weeks. comparison between the "protective strategy group" (earplug and sleep mask) and the control group (conventional strategy).'}, {'measure': 'Incidence of posttraumatic stress disorder syndrome', 'timeFrame': 'At day 90', 'description': 'comparison between the "protective strategy group" (earplug and sleep mask) and the control group (conventional strategy).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sleep quality', 'Sleep architecture', 'Intensive care unit', 'Light', 'Noise', 'Earplug', 'Sleep mask'], 'conditions': ['Intensive Care Unit Patients']}, 'referencesModule': {'references': [{'pmid': '29157258', 'type': 'DERIVED', 'citation': 'Demoule A, Carreira S, Lavault S, Pallanca O, Morawiec E, Mayaux J, Arnulf I, Similowski T. Impact of earplugs and eye mask on sleep in critically ill patients: a prospective randomized study. Crit Care. 2017 Nov 21;21(1):284. doi: 10.1186/s13054-017-1865-0.'}]}, 'descriptionModule': {'briefSummary': 'Sleep architecture is deeply altered in intensive care unit (ICU patients). Among factors involved in poor sleep quality are environmental factors, such as light and noise, which are an unavoidable consequence of cares.\n\nThe aim of the study is to evaluate the benefit of earplug and sleep mask on sleep architecture and quality in ICU patients.', 'detailedDescription': 'It is well demonstrated that sleep architecture is deeply altered in intensive care unit (ICU patients). The consequences of this alteration are multiple: neuropsychological complication such as delirium, long-term sequels such as post-traumatic stress disorders, alteration of the circadian fluctuation of various hormones with well demonstrated deleterious impact, alteration of the immune response that may promote nosocomial infections and, finally, a decrease of respiratory muscle endurance that may compromise weaning from mechanical ventilation.\n\nVarious mechanisms contribute to sleep alteration in ICU patients, including intrinsic factors linked to disease severity, factors related to therapies such as mechanical ventilation and sedation, and environmental factors. Among environmental factors, light and noise are an unavoidable consequence of cares that strongly contribute to sleep alteration in ICU patients. It is of notice that few studies have focused on strategies to protect ICU patients against noise and light such as the systematic use of earplug and sleep mask. Although the benefit of earplug and sleep mask on sleep quality has been demonstrated in healthy subjects submitted to an environment similar to ICU, it has never been evaluated in ICU patients.\n\nThe aim of the study is to evaluate the benefit of earplug and sleep mask (designated as "protective strategy) on sleep architecture and quality in ICU patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria :\n\n* Admission in the ICU with expected duration of stay \\> 48hrs.\n* Level of sedation \\< 4 on Ramsay scale.\n* Interruption of sedation \\> 12 hrs\n* Analgesia with a maximal dose of morphine \\< 0.01 mg/Kg/h\n* Vasopressive therapy not exceeding 0.3 mg/Kg/min for epinephrine and 10 mg/Kg/min for dopamine.\n* Informed consent by patients or next of kind.\n\nExclusion criteria :\n\n* Known sleep disorder (apnea syndrome, narcolepsy, restless leg syndrome).\n* Central nervous disease that might impact sleep architecture or the interpretation of EEG recordings.\n* Severe liver encephalopathy (stage 3 or 4)\n* Ongoing sepsis\n* Pregnancy.\n* Age \\< 18 yrs.\n* No health insurance.'}, 'identificationModule': {'nctId': 'NCT02292134', 'acronym': 'EARS', 'briefTitle': 'Improving Sleep Quality in ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Benefit of an Individual Protection Against Noise and Light on Sleep Quality in ICU Patients', 'orgStudyIdInfo': {'id': 'P081115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'earplug and sleep mask', 'interventionNames': ['Device: earplug and sleep mask']}, {'type': 'NO_INTERVENTION', 'label': 'control'}], 'interventions': [{'name': 'earplug and sleep mask', 'type': 'DEVICE', 'description': 'Individual protection against light and noise using earplugs and a sleep mask from 2 hrs to 8 hrs', 'armGroupLabels': ['earplug and sleep mask']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Intensive Care Unit and Respiratory division ; Groupe hospitalier Pitie-Salpetriere and Universite Pierre et Marie Curie Paris 6', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}