Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-03-02 @ 8:40 PM
Study NCT ID:
NCT02012868
Status:
COMPLETED
Last Update Posted:
2020-03-25
First Post:
2013-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Bariatric Surgery on Obstructive Sleep Apnea in a Danish Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D015431', 'term': 'Weight Loss'}], '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'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D015390', 'term': 'Gastric Bypass'}], 'ancestors': [{'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D005763', 'term': 'Gastroenterostomy'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-23', 'studyFirstSubmitDate': '2013-11-26', 'studyFirstSubmitQcDate': '2013-12-10', 'lastUpdatePostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'ESS score', 'timeFrame': 'Change from baseline in ESS score at one year', 'description': 'ESS is a questionnaire that gives an impression on quality of sleep. High score indicate poor quality of sleep. Low score indicate high quality of sleep.'}], 'primaryOutcomes': [{'measure': 'AHI', 'timeFrame': 'Change from baseline in AHI at one year', 'description': 'Obstructive sleep apnoea is defined by the apnoea/hypopnoea index (AHI). This can be accessed by embletta monitoring during sleep.'}], 'secondaryOutcomes': [{'measure': 'weight', 'timeFrame': 'Change from baseline in weight at one year', 'description': 'No need.'}, {'measure': 'Circumference of neck', 'timeFrame': 'Change from baseline in Circumference at neck at one year', 'description': 'Circumference of the neck measured in inches.'}, {'measure': 'mean saturation during sleep', 'timeFrame': 'Change from baseline in mean saturation during sleep at one year', 'description': 'saturation during sleep is measured by a pulsoxymetry.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obstructive sleep apnoea', 'weight loss', 'bariatric surgery'], 'conditions': ['Obstructive Sleep Apnoea (OSA)']}, 'descriptionModule': {'briefSummary': 'Studies have shown high prevalence (60-94%) of obstructive sleep apnoea (OSA) among patients undergoing bariatric surgery.\n\nFifteen studies are published investigating the effect of bariatric surgery on OSA. All of them conclude a highly positive effect on OSA by bariatric surgery and weight loss. However these studies are biased by a huge number of drop outs. The drop out rate in the studies are around 60 percent.\n\nThe Investigators state that the prevalence of OSA among patients undergoing bariatric surgery in Denmark is high. The Investigators state that the effect of bariatric surgery is significant on severity of OSA. The Investigators state that we can perform a study without a huge number of dropouts.', 'detailedDescription': 'Obstructive sleep apnea (OSA) is a clinical syndrome characterized by occlusion of upper airways during sleep. The occlusions results in shortly hypoxia, which awakes the patient. When the patient awakes, activity in the pharyngeal muscles results in opening of the upper airway again.\n\nOSA is associated with overweight. Studies have shown high prevalence (60-94%) of obstructive sleep apnea (OSA) among patients undergoing gastric bypass (bariatric) surgery.\n\nFifteen studies have investigated the effect of bariatric surgery on OSA. All of them conclude a highly positive effect on OSA by bariatric surgery and the following weight loss. However, a huge number of dropouts biases these studies. The dropout rate in the studies are around 60 percent. No studies are from northern Europe.\n\nThe Investigators want to perform a study investigating the prevalence of OSA among over weighted patients undergoing bariatric surgery in Denmark.\n\nThe Investigators state that the prevalence of OSA among patients undergoing bariatric surgery in Denmark is high. The investigators state that the effect of bariatric surgery is significant on severity of OSA. The Investigators state that they can perform a study without a huge number of dropouts.\n\nThe investigators investigate patients by making sleep monitoring by embletta. During one night of sleep with this apparatus, the investigators will get information on number of wake-ups during sleep, the apnea-hypopnea index and saturation during sleep. All of this gives the investigators information whether the patient have OSA or not.\n\nPatients will undergo sleep monitoring prior to surgery. The time interval from monitoring to day of surgery varies from 1 month to one day. the investigators repeat the sleep monitoring one year after date of surgery. Differences in primary endpoint and secondary endpoints is calculated.\n\nToday all of the subjects have undergone surgery. From November 1.2013 the investigators invites all patients to sleep monitoring once again. The investigators were hot able to register this trial before this date because of the political situation in the US. This site was closed. The Investigators hope that the investigators still are able to register the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients attending bariatric surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 35\n* attending bariatric surgery\n\nExclusion Criteria:\n\n* retrognathia\n* micrognathia,\n* acromegaly\n* downs syndrome'}, 'identificationModule': {'nctId': 'NCT02012868', 'briefTitle': 'Effect of Bariatric Surgery on Obstructive Sleep Apnea in a Danish Cohort', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Effect of Bariatric Surgery on Obstructive Sleep Apnea in a Danish Cohort', 'orgStudyIdInfo': {'id': 'S-20120004jln'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'bariatric surgery, obstructive sleep apnoea', 'description': 'bariatric surgery', 'interventionNames': ['Procedure: bariatric surgery']}], 'interventions': [{'name': 'bariatric surgery', 'type': 'PROCEDURE', 'otherNames': ['gastric bypass'], 'armGroupLabels': ['bariatric surgery, obstructive sleep apnoea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6700', 'city': 'Esbjerg', 'country': 'Denmark', 'facility': 'Department of endocrinology, Southern west hospital', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}], 'overallOfficials': [{'name': 'Philip Lage-Hansen, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of endocrinology, Esbjerg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor, PhD', 'investigatorFullName': 'Jeppe Gram', 'investigatorAffiliation': 'University of Southern Denmark'}}}}