Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-03-09 @ 4:05 AM
Study NCT ID:
NCT01903135
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2013-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Obesity Hypoventilation Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010845', 'term': 'Obesity Hypoventilation Syndrome'}], 'ancestors': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007040', 'term': 'Hypoventilation'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1004}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-31', 'studyFirstSubmitDate': '2013-07-16', 'studyFirstSubmitQcDate': '2013-07-18', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Obesity Hypoventilation Syndrome (OHS) in obese subjects referred to clinical laboratories for regular blood test analysis.', 'timeFrame': 'From date of inclusion until the end of the study currently planned (up to 2 years)', 'description': 'OHS prevalence, validated by arterial blood gases analysis, will be assessed by the percentage of patients with OHS among all patients included in the study'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and specificity of plasmatic [HCO3-] to detect OHS', 'timeFrame': 'From date of inclusion to the end of the study currently planned (2 years)', 'description': 'A ROC curve will determine if the threshold of 27 mmol/L has the best diagnostic value.\n\nDecision trees will show if the diagnostic value of plasmatic \\[HCO3-\\]could be optimized by a combination with other clinical parameters.'}, {'measure': 'Prevalence of metabolic and cardiovascular comorbidities in patients with OHS', 'timeFrame': 'From date of inclusion to the end of the study currently planned (2 years)', 'description': 'Prevalence will be estimated by the percentage and the confidence interval. Prevalences of metabolic and cardiovascular comorbidities among patients with OHS and without OHS will be compared by a KHI-2 test or Fisher Exact depends on the theorical number.'}, {'measure': 'To determine which medical specialties referred patients with OHS to clinical labs', 'timeFrame': 'From date of inclusion to the end of the study currently planned (2 years)', 'description': 'estimated by percentage'}, {'measure': 'Incidence of serious health events at 1 and 2-year follow-up', 'timeFrame': 'From time of OHS diagnostic to 1 and 2-year follow-up', 'description': 'Cardiovascular, metabolic and respiratory events (measured by percentages in OHS group and non-OHS group) will be compared by logistic regressions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity Hypoventilation Syndrome', 'Prevalence', 'Bicarbonate'], 'conditions': ['Obesity Hypoventilation Syndrome']}, 'descriptionModule': {'briefSummary': 'Rationale of the "BIO-OHS" study (Prevalence of Obesity Hypoventilation Syndrome):\n\nThe overall prevalence of Obesity Hypoventilation Syndrome (OHS) has never been directly assessed in the general population. Actually, this prevalence has been assessed in patients referred to sleep clinics with a potential diagnosis of sleep-disordered breathing or in patients already diagnosed with sleep apnea. The purpose of this study is to determine the prevalence of Obesity Hypoventilation syndrome in obese patients referred to clinical laboratories for regular follow-up medical analysis.', 'detailedDescription': 'No additional description'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old ans more\n* BMI over 30 kg/M2\n* Stable state (respiratory, metabolic and cardio-vascular) for the last 2 months\n* Addressed to a clinical labs for a blood check-up whatever the prescription\n\nExclusion Criteria:\n\n* No social security\n* Non cooperative patient, as judged by the investigator'}, 'identificationModule': {'nctId': 'NCT01903135', 'acronym': 'BIO-OHS', 'briefTitle': 'Prevalence of Obesity Hypoventilation Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'AGIR à Dom'}, 'officialTitle': 'Prevalence of Obesity Hypoventilation Syndrome in Subjects With Obesity Referred to Clinical (Medical Analysis) Laboratories for Regular Follow-up', 'orgStudyIdInfo': {'id': '13-AGIR-02'}, 'secondaryIdInfos': [{'id': '2013-A00744-41', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '[HCO3-] >= 27 mmol/L (Group 1)', 'description': 'All obese patients with plasmatic\\[HCO3-\\] \\>= 27 mmol/L will be addressed to a pneumologist. The pneumology investigations will establish(or not) the diagnosis of OHS', 'interventionNames': ['Procedure: Blood test analysis in the clinical labs', 'Procedure: Pneumologist consult to establish the diagnosis of OHS']}, {'type': 'OTHER', 'label': '[HCO3-]< 27mmol/L+pneumologist (Group 2)', 'description': 'Among obese patients with serum \\[HCO3-\\]\\< 27 mmol/L, 300 randomized patients will be addressed to a pneumologist. The pneumology investigations will refute(or not)the diagnosis of OHS.', 'interventionNames': ['Procedure: Blood test analysis in the clinical labs', 'Procedure: Pneumologist consult to establish the diagnosis of OHS']}, {'type': 'OTHER', 'label': '[HCO3-]< 27 mmol/L (Group 3)', 'description': 'Obese patients with a \\[HCO3-\\]\\<27 mmol/L randomized to group 3 will receive usual medical follow-up (end of study)', 'interventionNames': ['Procedure: Blood test analysis in the clinical labs']}], 'interventions': [{'name': 'Blood test analysis in the clinical labs', 'type': 'PROCEDURE', 'description': 'for specific measurement of plasmatic bicarbonate', 'armGroupLabels': ['[HCO3-] >= 27 mmol/L (Group 1)', '[HCO3-]< 27 mmol/L (Group 3)', '[HCO3-]< 27mmol/L+pneumologist (Group 2)']}, {'name': 'Pneumologist consult to establish the diagnosis of OHS', 'type': 'PROCEDURE', 'description': 'complete respiratory check-up: Arterial blood gases analysis, spirometry, anthropometry, polygraphy or polysomnography.\n\nMedical history, previous treatments.', 'armGroupLabels': ['[HCO3-] >= 27 mmol/L (Group 1)', '[HCO3-]< 27mmol/L+pneumologist (Group 2)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Échirolles', 'country': 'France', 'facility': 'Cabinet de Pneumologie Grenoble SUD', 'geoPoint': {'lat': 45.14603, 'lon': 5.71441}}, {'city': 'Échirolles', 'country': 'France', 'facility': 'Laboratoire MEDIBIO Les Cedres', 'geoPoint': {'lat': 45.14603, 'lon': 5.71441}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'Hôpital Michallon, Laboratoire EFCR et Sommeil', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Perpignan', 'country': 'France', 'facility': 'Cabinet de Pneumologie Perpignan', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'city': 'Thuir', 'country': 'France', 'facility': "Laboratoire d'analyses medicales de Thuir", 'geoPoint': {'lat': 42.6322, 'lon': 2.75577}}], 'overallOfficials': [{'name': 'Jean-Louis Pepin, Pr, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AGIR à Dom', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}