Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-25 @ 10:08 AM
Study NCT ID:
NCT02588469
Status:
COMPLETED
Last Update Posted:
2018-01-24
First Post:
2015-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With OSA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-22', 'studyFirstSubmitDate': '2015-07-22', 'studyFirstSubmitQcDate': '2015-10-26', 'lastUpdatePostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Obstructive sleep apnea severity at 3 months.', 'timeFrame': 'This study includes 2 assessments : baseline (T0) and 3 months (T3)', 'description': 'Obstructive Sleep Apnea change will be assessed with polysomnography system at baseline and after three months'}], 'secondaryOutcomes': [{'measure': 'Upper airway resistances', 'timeFrame': 'This study includes 2 assessments : baseline (T0) and 3 months (T3)', 'description': 'upper airway resistance will be assessed by acoustic method'}, {'measure': 'Fluid shift', 'timeFrame': 'This study includes 2 assessments : baseline (T0) and 3 months (T3)', 'description': 'fluid shift will be assessed by bioimpedance analysis'}, {'measure': 'Calf and neck circumferences', 'timeFrame': 'This study includes 2 assessments : baseline (T0) and 3 months (T3)', 'description': 'Calf and neck circumferences will be assessed with nonelastic tape'}, {'measure': 'Calf and neck circumferences', 'timeFrame': 'This study includes 2 assessments : baseline (T0) and 3 months (T3)', 'description': 'Calf and neck circumferences will be assessed by plethysmography'}, {'measure': 'Anthropometric parameters', 'timeFrame': 'This study includes 2 assessments : baseline (T0) and 3 months (T3)', 'description': 'weight, height, waist and hip circumferences (body weight scale, standing stadiometer and non-elastic tape)'}, {'measure': 'Body composition', 'timeFrame': 'This study includes 2 assessments : baseline (T0) and 3 months (T3)', 'description': 'fat mass, fat free mass ( by bioimpedance analysis)'}, {'measure': 'Pulmonary function during exercise', 'timeFrame': 'This study includes 2 assessments : baseline (T0) and 3 months (T3)', 'description': 'Incremental maximal exercise in cycling ergometer with respiratory gas assessment (metamax)'}, {'measure': 'Metabolic responses', 'timeFrame': 'This study includes 2 assessments : baseline (T0) and 3 months (T3)', 'description': 'Glucose, LDL-Cholesterol, HDL-Cholesterol, Total Cholesterol, Triglycerides (ELISA and RIA technics)'}, {'measure': 'Hormonal responses', 'timeFrame': 'This study includes 2 assessments : baseline (T0) and 3 months (T3)', 'description': 'Insulin, leptin, adiponectin, catecholamines (ELISA and RIA technics)'}, {'measure': 'Inflammatory responses', 'timeFrame': 'This study includes 2 assessments : baseline (T0) and 3 months (T3)', 'description': 'C-reactive protein (ELISA and RIA technics)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pediatric obesity', 'obstructive sleep apnea', 'physical exercise', 'compression socks', 'rostral fluid shift'], 'conditions': ['Pediatric Obesity', 'Sleep Apnea, Obstructive']}, 'referencesModule': {'references': [{'pmid': '32008915', 'type': 'DERIVED', 'citation': 'Roche J, Corgosinho FC, Damaso AR, Isacco L, Miguet M, Fillon A, Guyon A, Moreira GA, Pradella-Hallinan M, Tufik S, Tulio de Mello M, Gillet V, Pereira B, Duclos M, Boirie Y, Masurier J, Franco P, Thivel D, Mougin F. Sleep-disordered breathing in adolescents with obesity: When does it start to affect cardiometabolic health? Nutr Metab Cardiovasc Dis. 2020 Apr 12;30(4):683-693. doi: 10.1016/j.numecd.2019.12.003. Epub 2019 Dec 16.'}, {'pmid': '29852904', 'type': 'DERIVED', 'citation': 'Roche J, Gillet V, Perret F, Mougin F. Obstructive Sleep Apnea and Sleep Architecture in Adolescents With Severe Obesity: Effects of a 9-Month Lifestyle Modification Program Based on Regular Exercise and a Balanced Diet. J Clin Sleep Med. 2018 Jun 15;14(6):967-976. doi: 10.5664/jcsm.7162.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effects of physical exercise, associated or not with venous compression of the leg, on obstructive sleep apnea (OSA) severity and upper airway resistance in obese teenagers. Half of the participants will undergo physical exercise and compression socks program, and the other half of subjects will undergo physical exercise program without compression socks.', 'detailedDescription': 'Obesity is an important factor of OSA development in children and teenagers, and physical activity is a relevant alternative to promote OSA decrease with ou without weight loss.\n\nPhysical activity, beyond the improvement of body composition and exercise cardiorespiratory capacity, restricts fluid retaining in the lower limb of the leg by the activation of musculovenous pump. Fluid retaining is involved in OSA severity because of nocturnal fluid shift from legs to rostral zone which promotes pharyngeal oedema development and upper airway collapsibility.\n\nIt has been previously shown that venous compression leads to beneficial fluid regulation in OSA subjects and appears as an efficient tool in OSA management.\n\nTo the investigators knowledge no study assess the impact of the cumulative effect of physical and venous compression program on upper airway resistances in obese teenager with OSA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obese adolescents (BMI \\> 97th percentile),\n* patients aged from 12 to 17 years old, (born between 07/01/2003 and 09/01/1197),\n* enrolled in a pediatric obesity center with diet and physical activity programs and psychological management,\n* without observed tonsils hypertrophy (Mallampati and Friedman scores),\n* without contraindication for bioimpedance analysis, acoustic method and stain gauge plethysmography,\n* with physical activity certificate issued by a cardiologist\n* covered by the national insurance scheme of his/her legal representative,\n* having signed, as well as his(her) legal representative, the informed consent of participation.\n\nExclusion Criteria:\n\n* Non obese adolescents (BMI \\< 97th percentile)\n* patients aged under 12 or over 17 years old,\n* not enrolled in a pediatric obesity center with diet and physical activity programs and psychological management,\n* with observed tonsils hypertrophy (Mallampati and Friedman scores),\n* with contraindication for bioimpedance analysis, acoustic method and stain gauge plethysmography,\n* without physical activity certificate issued by a cardiologist\n* uncovered by the national insurance scheme of his/her legal representative,\n* not having signed, as well as his(her) legal representative, the informed consent of participation.'}, 'identificationModule': {'nctId': 'NCT02588469', 'acronym': 'OBESOMAC', 'briefTitle': 'Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With OSA', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Effects of Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With Obstructive Sleep Apnea Syndrome', 'orgStudyIdInfo': {'id': 'P/2015/250'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional group', 'description': 'Physical activity program coupled with compression socks wearing during 3 months.', 'interventionNames': ['Other: Interventional group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'Physical activity program without compression socks during 3 months.', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Interventional group', 'type': 'OTHER', 'description': 'Venous compression leads to beneficial fluid regulation in OSA participants and appears as an efficient tool in OSA management.\n\nTo the investigators knowledge no study assess the impact of the cumulative effect of physical and venous compression program on upper airway resistances in obese teenager with OSA.', 'armGroupLabels': ['Interventional group']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'Standard obesity care with physical activity program', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39110', 'city': 'Salins-les-Bains', 'country': 'France', 'facility': 'Centre de soins de suite et de réadaptation La Beline', 'geoPoint': {'lat': 46.94663, 'lon': 5.87763}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}