Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-31 @ 7:34 PM
Study NCT ID:
NCT00854334
Status:
COMPLETED
Last Update Posted:
2018-03-09
First Post:
2009-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Co-existent Obstructive Sleep Apnea (OSA) and Obesity: Finding Non-exercise Activity Thermogenesis (NEAT) Targets for Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-07', 'studyFirstSubmitDate': '2009-03-02', 'studyFirstSubmitQcDate': '2009-03-02', 'lastUpdatePostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NEAT (kcal/day)', 'timeFrame': '10 day period'}], 'secondaryOutcomes': [{'measure': 'Physical activity behavior (minutes of moderate-vigorous physical activity as directly measured by accelerometry), appetite regulating hormone profile and self-report appetite assessment.', 'timeFrame': '10 day period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sleep', 'Overweight', 'Physical activity', 'Appetite', 'NEAT'], 'conditions': ['Childhood Obesity', 'Childhood Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'Rationale: Obesity is an increasing childhood epidemic in Canada. Obstructive sleep apnea (OSA) is a complication of obesity which causes cardiovascular disease, reduced quality of life, and premature death. While the complex interactions between obesity and OSA are not entirely clear, we hypothesize that these conditions may compound each other by:\n\n1. decreasing physical activity and total energy expenditure by reducing both non-exercise physical pursuits (NEAT- non-exercise activity thermogenesis) and purposeful physical activity.\n2. alterations in the secretion of appetite-controlling hormones, which may lead to increases in energy intake.\n\nObjective: To determine whether the presence of both obesity and OSA in children is associated with a decrease in physical activity and alterations in appetite-regulating hormones greater than those seen in either condition alone or compared to controls.\n\nMethods: Comparison of children 10-17 years with obesity and OSA, obesity alone, OSA alone and neither condition, for the following outcomes: (1) NEAT (kcal/day) (2) Physical activity behavior, appetite regulating hormone profile and self-report appetite assessment.\n\nUnique Aspects: This study combines expertise in sleep medicine, exercise physiology and obesity. Conclusions from this study will better characterize this high-risk clinical population so that innovative strategies targeting improvements in lifestyle behaviors can be developed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Subjects will be recruited from those scheduled to undergo polysomnography in the sleep laboratory at the Children's Hospital of Eastern Ontario", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age 10-17 years\n* coming for polysomnography at the Children's Hospital of Eastern Ontario\n\nExclusion Criteria:\n\n* children receiving treatment for OSA with CPAP (continuous positive airway pressure) or bi-level therapy\n* craniofacial abnormalities\n* genetic syndromes\n* neuromuscular disease\n* tracheostomy\n* medications that may affect appetite or energy balance (systemic corticosteroids)"}, 'identificationModule': {'nctId': 'NCT00854334', 'briefTitle': 'Co-existent Obstructive Sleep Apnea (OSA) and Obesity: Finding Non-exercise Activity Thermogenesis (NEAT) Targets for Intervention', 'organization': {'class': 'INDIV', 'fullName': 'Katz, Sherri Lynne, M.D.'}, 'officialTitle': 'Co-existent OSA and Obesity: Finding NEAT Targets for Intervention', 'orgStudyIdInfo': {'id': 'Neat-OSA-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1.', 'description': 'Children with both obesity and obstructive sleep apnea'}, {'label': '2', 'description': 'Children without the presence of both obesity and obstructive sleep apnea'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1H 8L1', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Childrens Hospital of Eastern Ontario', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Katz, Sherri Lynne, M.D.', 'class': 'INDIV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Katz, Sherri Lynne, M.D.', 'investigatorFullName': 'Dr. Sherry Lynn Katz', 'investigatorAffiliation': "Children's Hospital of Eastern Ontario"}}}}