Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-01-09 @ 4:06 AM
Study NCT ID:
NCT06527105
Status:
RECRUITING
Last Update Posted:
2024-09-25
First Post:
2024-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Sleep Quality on Outcomes After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D000071257', 'term': 'Emergence Delirium'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003693', 'term': 'Delirium'}, {'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': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-23', 'studyFirstSubmitDate': '2024-07-23', 'studyFirstSubmitQcDate': '2024-07-28', 'lastUpdatePostDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of sleep', 'timeFrame': '6 months', 'description': "On the morning after the intervention, patient's sleep quality will be assessed using Richard-Campbell sleep questionnaire (RCSQ). Each point in RCSQ will be scored using a visual analog score, ranging from 0-100. Total score will be calculated and then will be divided by 5."}], 'secondaryOutcomes': [{'measure': 'Atrial fibrillation', 'timeFrame': '6 months', 'description': 'Postoperative atrial fibrillation'}, {'measure': 'Delirium', 'timeFrame': '6 months', 'description': 'Postoperative Delirium'}, {'measure': 'Intensive care unit stay', 'timeFrame': '6 months', 'description': 'Duration of intensive care unit stay (in hours to days)'}, {'measure': 'Vasoactive inotropic score', 'timeFrame': '6 months', 'description': 'Vasoactive inotropic score is calculated by multiplying the dose of each vasoactive drug used with 10. (minimum score is 0, while maximum score can go upto 20. Higher the score worse is the outcome'}, {'measure': 'Mechanical ventilation', 'timeFrame': '6 months', 'description': 'Duration of mechanical ventilation (hours)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac surgery', 'Sleep quality'], 'conditions': ['Sleep', 'Atrial Fibrillation', 'Delirium, Postoperative', 'Complications, Postoperative']}, 'descriptionModule': {'briefSummary': "Sleep is a basic human need and is essential for good quality of life, good health. In fact, humans spend one third of their life time in sleeping or attempting to do so. However, sleep is not given due importance in intensive care unit (ICU)'s, although it is critical in healing process. Patient's usually get admitted to the hospital few days prior to the surgery, for complete evaluation, depending on the procedure planned. Hospital environment being, an entirely new place for inpatients, will invariably affect their sleep. Sleep deprivation is one of the major sources of anxiety and stress in all the patients during ICU stay. This means that most of patients are sleep deprived, by the time they are admitted to ICU.\n\nThe negative effects of sleep deprivation include postoperative brain dysfunction like inattention, restlessness, hallucinations, agitation, aggressiveness. The degree of cognitive impairment may range from subtle derangements in attention, reason, clarity of thought and capacity of decision making to confusion and delirium. Sleep deprivation can also induce hypertension, fatigue, metabolic disorders, cerebrovascular and cardiovascular disease"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult cardiac surgical patients aged above 18years undergoing elective cardiac surgery\n\nExclusion Criteria:\n\n* Not willing to give consent\n* Preoperative sleep medications use\n* Preoperative psychological disorders, on mechanical ventilation for \\>12hrs, dementia, cerebrovascular accident'}, 'identificationModule': {'nctId': 'NCT06527105', 'briefTitle': 'Impact of Sleep Quality on Outcomes After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Amrita Institute of Medical Sciences & Research Center'}, 'officialTitle': 'The Effects of Non-pharmacological Interventions on the Quality of Sleep in Cardiac Surgical Patients', 'orgStudyIdInfo': {'id': 'IEC-AIMS-2023-CARDANES-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Interventional group', 'description': 'Eye masks and Ear plugs given during sleep', 'interventionNames': ['Device: Eye masks and ear plugs']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Routine care given without any intervention'}], 'interventions': [{'name': 'Eye masks and ear plugs', 'type': 'DEVICE', 'description': 'Eye masks and ear plugs given during sleeping time in Icu After cardiac surgery', 'armGroupLabels': ['Interventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '682041', 'city': 'Kochi', 'state': 'Kerala', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Nagarjuna P, MD, DM', 'role': 'CONTACT'}], 'facility': 'Dr. Nagarjuna', 'geoPoint': {'lat': 9.93988, 'lon': 76.26022}}], 'centralContacts': [{'name': 'Nagarjuna P, MD, DM', 'role': 'CONTACT', 'email': 'drarjun83@gmail.com', 'phone': '9177208286', 'phoneExt': '091'}, {'name': 'Nagarjuna P', 'role': 'CONTACT', 'phone': '7981144584'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amrita Institute of Medical Sciences & Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Department of Cardiac Anesthesia', 'investigatorFullName': 'Nagarjuna P', 'investigatorAffiliation': 'Amrita Institute of Medical Sciences & Research Center'}}}}