Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT01852305
Status:
TERMINATED
Last Update Posted:
2021-04-28
First Post:
2013-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obstructive Sleep Apnea in Bariatric Surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010092', 'term': 'Oximetry'}], 'ancestors': [{'id': 'D001784', 'term': 'Blood Gas Analysis'}, {'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 316}}, 'statusModule': {'whyStopped': 'due to lack resources', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2013-04-29', 'studyFirstSubmitQcDate': '2013-05-08', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The average cost for obstructive sleep apnea management', 'timeFrame': '30 days after surgery', 'description': 'The average cost for obstructive sleep apnea management during the period from the initial assessment visit to 30 days after surgery.'}, {'measure': 'The incidence of postoperative adverse events', 'timeFrame': '30 days after surfery', 'description': 'The composite incidence of postoperative adverse events'}], 'secondaryOutcomes': [{'measure': 'Number of visits to the health care professionals', 'timeFrame': '1 year', 'description': 'The secondary outcomes will be the number of visits to MDs, emergency and the length of hospital stay within the same period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obstructive sleep apnea', 'Continuous positive airway pressure (CPAP)', 'Oximetry', 'Bariatric Surgery', 'Anesthesia', 'Oxygen desaturation index (ODI)'], 'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'Purpose:\n\nThe purpose of this study is to develop a novel pathway to decrease the cost and waiting time to manage bariatric surgical patients with obstructive sleep apnea.\n\nHypotheses:\n\nCompared to the current perioperative pathway, the proposed novel pathway incorporating overnight oximetry and perioperative sleep apnea precautions is safe and more cost effective for evaluating and managing obstructive sleep apnea in the bariatric surgical patients.\n\nTo decrease the cost and waiting time, we proposed a novel perioperative pathway to manage obstructive sleep apnea in the bariatric patients. In this pathway, the patient will be screened by the STOP-Bang questionnaire. The recruited patients will be randomized into two groups:\n\nThe STOP-Bang questionnaire score is ≥4 then you will be assigned to any one of these groups\n\n* sleep study group (group 1) or\n* oximetry group (group 2).', 'detailedDescription': 'The potential patients will be screened by the STOP-Bang questionnaire. Those with a score ≥4 will be randomized into Sleep Study group or Oximetry group. The patients in the Sleep Study group will be referred to a sleep medicine specialist who is part of the Bariatric Surgery Psychosocial Program. In the Sleep Study group, patients will undergo sleep studies overnight in a sleep laboratory. At the same time, they will also wear the oximeter wristwatch to measure overnight oximetry. Depending on the sleep study results and medical history, a decision will be made regarding therapeutic options. If the patient has severe sleep apnea (AHI\\>30) or moderate sleep apnea (AHI\\>15 to \\<30) with significant co-morbidities (e.g. cardiovascular disease, diabetes), CPAP treatment will be recommended. For mild sleep apnea (AHI\\>5 to \\<15) or moderate sleep apnea without significant co-morbidities, CPAP will not be required. If patient is not able to tolerate or refuses CPAP, dental device and positional therapy will be recommended.\n\nThe patients in the Oximetry group will undergo overnight pulse oximetry. The patients with ODI\\>10 events/hour will be referred to the sleep medicine specialist. Since the patients with ODI\\>10 had a high probability 69%) to have moderate and severe OSA. A split- night PSG will be employed to confirm OSA diagnosis and to titrate CPAP with in patients with ODI\\>10. The 1st part of the night will be a sleep study and depending on AHI, CPAP titration will be done for the 2nd part of the night. Compared to Sleep Study group, only one night instead of two nights of sleep studies is needed in patients with ODI\\>10 events/hour. The patients with ODI ≤ 10 events/h will undergo surgery with routine care plus sleep apnea perioperative precautions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion/Exclusion criteria: The patients who meet the following criteria will be recruited.\n\n* Patients undergoing bariatric surgery with American Society of Anaesthesiologists (ASA) score 1-4 will be approached.\n* The patients with any of the following conditions will be excluded:\n\n 1. Unable or not willing to give an informed consent;\n 2. Potential problems with EEG;\n 3. Patients with diagnosed OSA.\n 4. Patients having sleep study before.\n 5. Age: \\< 18 years having sleep study before. -'}, 'identificationModule': {'nctId': 'NCT01852305', 'briefTitle': 'Obstructive Sleep Apnea in Bariatric Surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Would A New Pathway Managing Obstructive Sleep Apnea in Bariatric Surgical Patients Be Safe and Cost-effective?', 'orgStudyIdInfo': {'id': '27/2/2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lab Sleep Study (group 1)', 'description': 'The patients in the Sleep Study group will be referred to a sleep medicine specialist who is part of the Bariatric Surgery Psychosocial Program. In the Sleep Study group, patients will undergo sleep studies overnight in a sleep laboratory. At the same time, they will also wear the oximeter wristwatch to measure overnight oximetry.', 'interventionNames': ['Other: Lab Sleep Study Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oximetry group (group 2)', 'description': 'The patients in the Oximetry group will undergo overnight pulse oximetry. The patients with ODI\\>10 events/hour will be referred to the sleep medicine specialist.A split- night polysomnography(PSG) will be employed to confirm obstructive sleep apnea OSA) diagnosis. The 1st part of the night will be a sleep study and depending on AHI, CPAP titration will be done for the 2nd part of the night.', 'interventionNames': ['Device: Oximetry']}], 'interventions': [{'name': 'Lab Sleep Study Group', 'type': 'OTHER', 'otherNames': ['Lab polysomnography study'], 'description': 'Patients in this group will under go lab sleep study overnight at the sleep clinic.If the patient has severe sleep apnea (AHI\\>30) or moderate sleep apnea (AHI\\>15 to \\<30) with significant co-morbidities (e.g. cardiovascular disease, diabetes), CPAP treatment will be recommended. For mild sleep apnea (AHI\\>5 to \\<15) or moderate sleep apnea without significant co-morbidities, CPAP will not be required. If patient is not able to tolerate or refuses CPAP, dental device and positional therapy will be recommended.', 'armGroupLabels': ['Lab Sleep Study (group 1)']}, {'name': 'Oximetry', 'type': 'DEVICE', 'otherNames': ['oximeter/group 2'], 'description': 'The patients in the Oximetry group will undergo overnight pulse oximetry. The patients with ODI\\>10 events/hour will be referred to the sleep medicine specialist.A split- night PSG will be employed to confirm OSA diagnosis. The 1st part of the night will be a sleep study and depending on AHI, CPAP titration will be done for the 2nd part of the night', 'armGroupLabels': ['Oximetry group (group 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': '399 Bathurst St.,Toronto Western Hopsital, Preadmission Clinic, Dept. of Anesthesia', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Frances Chung, MBBS FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network,University of Toronto'}, {'name': 'David Mazer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Michael's Hospital, University of Toronto"}, {'name': 'James Kulchyk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toronto East General Hospital, University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Unity Health Toronto', 'class': 'OTHER'}, {'name': 'Michael Garron Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Anesthesiologist', 'investigatorFullName': 'Dr. Frances Chung', 'investigatorAffiliation': 'University Health Network, Toronto'}}}}