Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT00880035
Status:
UNKNOWN
Last Update Posted:
2009-04-22
First Post:
2009-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Music on Reduction of Sedative Drugs in Mechanically Ventilated Intensive Care Unit Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003919', 'term': 'Diabetes Insipidus'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-04-20', 'studyFirstSubmitDate': '2009-04-10', 'studyFirstSubmitQcDate': '2009-04-10', 'lastUpdatePostDateStruct': {'date': '2009-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sedative drug consumption in mechanically ventilated ICU patients', 'timeFrame': '3 days'}], 'secondaryOutcomes': [{'measure': 'stress neuropeptide blood content evolution with MUSIC listening', 'timeFrame': '3 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sedative drug', 'stress', 'music', 'mechanical ventilation', 'IL-6', 'cortisol', 'prolactin', 'CRP', 'copeptin'], 'conditions': ['Sedative Drug Consumption', 'Mechanically Ventilated ICU Patients']}, 'descriptionModule': {'briefSummary': 'Major objective: a three-days interventional cross-over trial \\[one day music on, one day wash-out, one day music off\\]\\[two periods of listening/day\\], to evaluate:\n\n1. Impact on sedative drug consumption.\n2. Alteration of stress neuropeptide blood concentrations.\n\nPopulation: mechanically-ventilated ICU patients\n\nThe investigators hypothesize the music will decrease the need of sedative drugs and reduce the concentration of neuropeptides in circulation.', 'detailedDescription': 'The study will imply patients mechanically ventilated for more than 3 days, that require sedation with benzodiazepine and narcotics.\n\nThere will be two groups both of exposed to music and placebo (headphones without music). The study will be simple blind.\n\nSedation scale will be followed regularly. Vitals signs and adjustment of sedation will be recorded by the nurse on the ward. Blood test will be taken before and after placement of headphones in the morning. We will measure IL-6, cortisol, copeptin, prolactin, CRP.\n\nWe will analyse the total reduction dose of sedation and analgesia on a daily basis. We will consider a fall of 20% of medication to be significative.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults older than 18 years old\n* expected time of mechanical ventilation of more than 72 hours\n* sedation needs for a scale of Sedation-Agitation Scale (SAS) more than 1\n\nExclusion Criteria:\n\n* hearing impairment\n* pregnancy\n* needs of vasopressin\n* needs of curarisation'}, 'identificationModule': {'nctId': 'NCT00880035', 'acronym': 'MUSIC', 'briefTitle': 'Efficacy of Music on Reduction of Sedative Drugs in Mechanically Ventilated Intensive Care Unit Patients', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'M.U.S.I.C (MUSicotherapy in the Intensive Care) Interventional, Pilot, Cross-Over, in Mechanically-Ventilated Patients on ICU Ward', 'orgStudyIdInfo': {'id': '08-105-R2'}, 'secondaryIdInfos': [{'id': 'CRC-PAFI-09'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Group A: day 1 = music, day 2 = washout, day 3 = headphone without music', 'interventionNames': ['Device: MP3 music program listening']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Group B: day 1 = headphone without music, day 2 = washout, day 3 = music', 'interventionNames': ['Device: MP3 music program listening']}], 'interventions': [{'name': 'MP3 music program listening', 'type': 'DEVICE', 'description': '3 days with two 1 hour periods of headset music listening (1 day on, 1 day wash-out, 1 day off)', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'CHUS', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'centralContacts': [{'name': 'Olivier Lesur, MD', 'role': 'CONTACT', 'email': 'olivier.lesur@usherbrooke.ca', 'phone': '(819)346-1110'}, {'name': 'Catherine St-Pierre, MD', 'role': 'CONTACT', 'email': 'catherine.st-pierre@usherbrooke.ca', 'phone': '(819)346-1110'}], 'overallOfficials': [{'name': 'Olivier Lesur, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHUS and Université de Sherbrooke'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre de Recherche Clinique CHUS', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Olivier Lesur (PI) (Catherine St-Pierre co-PI)', 'oldOrganization': 'CRC-CHUS'}}}}