Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-03-03 @ 6:15 AM
Study NCT ID:
NCT04129918
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2019-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Light and Sound Modification on Sleep Quality and Circadian Rhythm in the MICU 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': 'D008027', 'term': 'Light'}, {'id': 'D004430', 'term': 'Ear Protective Devices'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D055620', 'term': 'Optical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study was conducted on 126 patients with 56 subjects in experimental group and 56 in control group in the MICU. Effect of ear plugs \\& eye mask on sleep among ICU patients: a randomized control trial The participants were randomly divided into two groups: with ear plugs and eye mask (experimental group) for 3 successive nights and without ear plugs and eye mask (control group). participants were provided a Sequentially numbered opaque sealed envelopes.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a single-center, prospective, randomized control trial in the medical intensive care unit of the Shin Kong Wu Ho-Su Memorial Hospital.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-07', 'studyFirstSubmitDate': '2019-10-13', 'studyFirstSubmitQcDate': '2019-10-15', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective sleep quality', 'timeFrame': 'baseline after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire', 'description': 'Subjective sleep quality'}, {'measure': 'Subjective sleep quality', 'timeFrame': 'Day 1 after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire', 'description': 'Subjective sleep quality'}, {'measure': 'Subjective sleep quality', 'timeFrame': 'Day 2 after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire', 'description': 'Subjective sleep quality'}, {'measure': 'Subjective sleep quality', 'timeFrame': 'Day 3 after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire', 'description': 'Subjective sleep quality'}], 'secondaryOutcomes': [{'measure': 'Objective sleep quality', 'timeFrame': 'baseline, Day 1, Day 2, and Day 3] using Actigraphy', 'description': 'Objective sleep quality'}, {'measure': 'Circadian rhythms', 'timeFrame': 'baseline, Day 1, Day 2, and Day 3] using Actigraphy', 'description': 'Circadian rhythms including 24-h autocorrelation coefficient (r24), in bed less than out of bed dichotomy index (I\\<O) collection, Mesor, Amplitude, and Acrophase from actigraphy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intensive care unit', 'sleep quality', 'circadian rhythm'], 'conditions': ['Intensive Care Unit', 'Ventilator', 'Sleep Quality', 'Circadian Rhythm']}, 'referencesModule': {'references': [{'pmid': '25594808', 'type': 'RESULT', 'citation': 'Pisani MA, Friese RS, Gehlbach BK, Schwab RJ, Weinhouse GL, Jones SF. Sleep in the intensive care unit. Am J Respir Crit Care Med. 2015 Apr 1;191(7):731-8. doi: 10.1164/rccm.201411-2099CI.'}, {'pmid': '25230376', 'type': 'RESULT', 'citation': 'Kamdar BB, Niessen T, Colantuoni E, King LM, Neufeld KJ, Bienvenu OJ, Rowden AM, Collop NA, Needham DM. Delirium transitions in the medical ICU: exploring the role of sleep quality and other factors. Crit Care Med. 2015 Jan;43(1):135-141. doi: 10.1097/CCM.0000000000000610.'}, {'pmid': '30215172', 'type': 'RESULT', 'citation': 'Boyko Y, Toft P, Ording H, Lauridsen JT, Nikolic M, Jennum P. Atypical sleep in critically ill patients on mechanical ventilation is associated with increased mortality. Sleep Breath. 2019 Mar;23(1):379-388. doi: 10.1007/s11325-018-1718-3. Epub 2018 Sep 13.'}, {'pmid': '29358448', 'type': 'RESULT', 'citation': 'Delaney LJ, Currie MJ, Huang HC, Litton E, Wibrow B, Lopez V, Haren FV. Investigating the application of motion accelerometers as a sleep monitoring technique and the clinical burden of the intensive care environment on sleep quality: study protocol for a prospective observational study in Australia. BMJ Open. 2018 Jan 21;8(1):e019704. doi: 10.1136/bmjopen-2017-019704.'}, {'pmid': '27109818', 'type': 'RESULT', 'citation': 'Solverson KJ, Easton PA, Doig CJ. Assessment of sleep quality post-hospital discharge in survivors of critical illness. Respir Med. 2016 May;114:97-102. doi: 10.1016/j.rmed.2016.03.009. Epub 2016 Mar 21.'}, {'pmid': '26785964', 'type': 'RESULT', 'citation': 'Beltrami FG, Nguyen XL, Pichereau C, Maury E, Fleury B, Fagondes S. Sleep in the intensive care unit. J Bras Pneumol. 2015 Nov-Dec;41(6):539-46. doi: 10.1590/S1806-37562015000000056.'}, {'pmid': '30113379', 'type': 'RESULT', 'citation': 'Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.'}, {'pmid': '29452801', 'type': 'RESULT', 'citation': 'Horsten S, Reinke L, Absalom AR, Tulleken JE. Systematic review of the effects of intensive-care-unit noise on sleep of healthy subjects and the critically ill. Br J Anaesth. 2018 Mar;120(3):443-452. doi: 10.1016/j.bja.2017.09.006. Epub 2017 Nov 23.'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate the effectiveness of light and sound modification in improving sleep qualit , and circadian rhythms in MICU patients with Mechanical Ventilation in Taiwan.\n\nHypothesis:\n\n1. The sleep quality in intervention group is significant improving than usual-care group at Day 1 (after the first intervention), Day 2 (after the second intervention), and Day 3 (after the third intervention).\n2. The circadian rhythm in intervention group is significant improving than usual-care group at Day 1 (after the first intervention), Day 2 (after the second intervention), Day 3 (after the third intervention).', 'detailedDescription': 'The subjects were divided into experimental and control groups. And the improving quality of sleep intervention was provided only in experimental group. In the experimental group，the patients used earplugs and eye masks during nighttime sleep. In the control group, the received routine intensive care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ICU stay for 7 days\n2. Endotracheal or Tracheostomy patients\n\nExclusion Criteria:\n\n1. Patients with ear injury\n2. Hearing impairment\n3. Eye disease or injuries'}, 'identificationModule': {'nctId': 'NCT04129918', 'acronym': 'MICU', 'briefTitle': 'Effects of Light and Sound Modification on Sleep Quality and Circadian Rhythm in the MICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shin Kong Wu Ho-Su Memorial Hospital'}, 'officialTitle': 'Effects of Light and Sound Modification on Sleep Quality and Circadian Rhythm in the Medical Intensive Care Unit Patients', 'orgStudyIdInfo': {'id': '20190804R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'ear plugs and eye mask for 3 successive nights', 'interventionNames': ['Behavioral: light and sound modification (earplugs and eye masks)']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'without ear plugs and eye mask'}], 'interventions': [{'name': 'light and sound modification (earplugs and eye masks)', 'type': 'BEHAVIORAL', 'description': 'In the experimental group，the patients used earplugs and eye masks during nighttime sleep.', 'armGroupLabels': ['experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '111', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'ShinKongHospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Hui-Mei Chen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'alice@ntunhs.edu.tw'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'starting 12 months after publication', 'ipdSharing': 'YES', 'description': 'partial collected IPD, all IPD that underlie results in a publication', 'accessCriteria': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shin Kong Wu Ho-Su Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}