Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-26 @ 12:58 AM
Study NCT ID:
NCT00213434
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Mandibular Advancement Device in the Treatment of Obstructive Sleep Apnea Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-25', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of polysomnographic data after 3 months of treatment by oral appliance in 2 groups: one with Herbst device adjusted in maximal mandibular advancement and a placebo group'}], 'secondaryOutcomes': [{'measure': 'Efficacy on clinical symptoms'}, {'measure': 'Tolerance of the oral appliance'}, {'measure': 'Identification of predictive factors of efficacy'}, {'measure': 'Feasibility of this therapeutic method'}]}, 'conditionsModule': {'keywords': ['prospective', 'randomized', 'polysomnography', 'orthodontic appliance, removable'], 'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the mandibular advancement by Herbst device is effective in the treatment of moderate obstructive sleep apnea patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate sleep apnea syndrome (10 \\< Respiratory Disorder Index \\< 30)\n* Body mass index (BMI) \\< 35 Kg/m2\n* Able to give their informed consent\n\nExclusion Criteria:\n\n* Pregnant women\n* Professional drivers requiring continuous positive airway pressure (CPAP) treatment\n* Psychiatric disorders, and patients unable to realise to study\n* Severe respiratory pathology which could interfere with the study\n* Morpheic epilepsy\n* Benzodiazepines intake\n* Chronic nasal obstruction\n* Ear, nose, and throat (ENT) pathology requiring surgery\n* Previous uvulopalatoplasty surgery\n* Temporomandibular joint pathology\n* Gum disease\n* Insufficient number of teeth to apply the oral appliance\n* Mobile teeth'}, 'identificationModule': {'nctId': 'NCT00213434', 'briefTitle': 'Evaluation of a Mandibular Advancement Device in the Treatment of Obstructive Sleep Apnea Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Prospective Evaluation of Mandibular Advancement by Herbst Device in the Treatment of Moderate Obstructive Sleep Apnea Syndrome', 'orgStudyIdInfo': {'id': '2000/055/HP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Herbst oral appliance', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'CHU de ROUEN', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'PORTIER PF Florence, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Rouen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}