Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT00837018
Status:
COMPLETED
Last Update Posted:
2013-03-05
First Post:
2009-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-04', 'studyFirstSubmitDate': '2009-02-03', 'studyFirstSubmitQcDate': '2009-02-03', 'lastUpdatePostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of maximal oxygen consumption : OSAS patient versus control subjects.', 'timeFrame': 'when the last patient realised the last visit'}], 'secondaryOutcomes': [{'measure': 'To compare physical exercise program to continuous positive airway pressure after 12 weeks of treatment in OSAS patients.', 'timeFrame': 'when the last patient realised the last visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['OSAS', 'exercise', 'metabolic', 'cardio-vascular'], 'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'The syndrome of obstructive sleep apnea (OSAS) is a public health problem that affects 2 to 4% of the general population. The patients with OSAS frequently complain of intolerance to exercise muscle fatigue and a significant even if they have not been fully characterized in the literature.\n\nThe anomalies in the exercise of patients with OSAS could be due to metabolic changes (insulin resistance and oxidative stress) and cardiovascular (impaired vascular reactivity).\n\nOur goal is both to determine whether these anomalies exist in patients with OSAS not obese, consider their relationship with the alteration of exercise capacity, and their reversibility in conventional PPC or by using the effects of physical activity regular.In this study Objectives: To establish whether the metabolic and vascular abnormalities associated with OSAS are associated with decreased parameters of physical fitness in relation to witnesses matched for age, sex and body mass index. Determine the effects of a re-training exercise on these parameters compared to the reference treatment, continuous positive pressure.\n\nMain objective: To compare the exercise capacity of OSAS patients compared with that of witnesses matched for age, sex and body mass index.\n\nSecondary objectives: To compare the effect of conventional treatment by continuous positive pressure (CPP) on cardiovascular and metabolic abnormalities of OSAS, with a therapeutic modality most original, physical activity.\n\nMethodology: Test physiopathological parallel group, controlled, randomized.', 'detailedDescription': 'Study type : Physiopathology trial Study design : Prospective randomized controled trial\n\nExpected Total Enrollment : 45 patients + 15 control subjects\n\nTested treatment : Physical exercise program (45 minutes, 3 times a week) Reference treatment : continuous positive airway pressure Treatment duration : 12 weeks (3 months) Total study duration : 2 years'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages Eligible for Study : 18 Years and above\n* Genders Eligible for Study: Both\n* Non obese : body mass index (BMI \\< 30 kg/m2)\n* Sedentary subjects : less physical activity than 30 minutes 3 time a week\n* and VOORIPS physical activity level questionnaire score \\< 9.\n\nObstructive sleep apnea syndrome (OSAS) patients :\n\n* Recently diagnosed (\\< 3 months)\n* AHI \\> 30 / hour (polysomnographic monitoring measurement)\n\nExclusion Criteria:\n\n* Excessive daytime sleepiness (Epworth score \\> 12)\n* Cardiovascular pathology (except controlled hypertension)\n* Pathology interacting with physical activity\n* Diabetes (known or treated)\n* Other participation to a clinical trial at the same'}, 'identificationModule': {'nctId': 'NCT00837018', 'acronym': 'EXAOS', 'briefTitle': 'Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients: Cardiovascular and Metabolic Characterisation During Exercise. Treatments Effect.', 'orgStudyIdInfo': {'id': '0520'}, 'secondaryIdInfos': [{'id': 'DGS 2005/0312', 'type': 'REGISTRY', 'domain': 'DGS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical exercise program', 'description': '45 min, 3 times a week', 'interventionNames': ['Other: physical exercise program']}], 'interventions': [{'name': 'physical exercise program', 'type': 'OTHER', 'description': '45 min, 3times a week', 'armGroupLabels': ['Physical exercise program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU, medecine du sport', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Bernard Wuyam, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'AGIR à Dom', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}