Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-31 @ 9:33 PM
Study NCT ID:
NCT03532828
Status:
COMPLETED
Last Update Posted:
2025-09-05
First Post:
2018-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interaction Between Body Posture and Nocturnal Sleeping Disorders in Dysgnathic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063169', 'term': 'Dentofacial Deformities'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2018-04-10', 'studyFirstSubmitQcDate': '2018-05-21', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 2D displacement range of the pressure center', 'timeFrame': 'Baseline, 1 year', 'description': 'Pressure center is recorded with force plates 1month before and 1 year after orthognathic surgery'}], 'secondaryOutcomes': [{'measure': 'Change in EOS criteria description', 'timeFrame': 'Baseline, 1 year', 'description': 'Criteria: pelvic tilt, cervical lordosis, C7 sagittal vertical axis, T1 slope thoracic kyphosis, lumbar lordosis , pelvic incidence, sacral slope. 1month before and 1 year after orthognathic surgery'}, {'measure': 'Change Stabilometric criteria description', 'timeFrame': 'Baseline, 1 year', 'description': '2D displacement of the pressure center according to the anteroposterior axis, the lateral axis. 2D displacement speed. 1month before and 1 year after orthognathic surgery'}, {'measure': 'Change in Cephalometric analysis', 'timeFrame': 'Baseline, 1 year', 'description': 'Lateral cephalograms are recorded before and after surgery'}, {'measure': 'Change Polygraphy criteria description', 'timeFrame': 'Baseline, 1 year', 'description': 'Apnea-hypopnea index, oxygen saturation , before and after orthognathic surgery'}, {'measure': 'Change in Dentofacial deformities description', 'timeFrame': 'Baseline, 1 year', 'description': 'Clinical evaluation before and after surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dentofacial Deformities', 'Sleep Disorder', 'Posture']}, 'descriptionModule': {'briefSummary': 'The role of head posture has been demonstrated in patient with dentofacial deformities. However, the relationship between body posture and jaw disorders is unclear. Moreover, patients with obstructive sleep apnea have the same anatomical abnormalities than patients with dentofacial deformities. The aim of this study is to evaluate, firstly, nocturnal sleeping disorders among patients with jaw disorders. Secondly, the investigators aim to evaluate the interaction between body posture, breathing and dentofacial deformities.\n\nA polygraphy will be performed on patient with dentofacial deformities before and after correcting jaw surgery. A postural evaluation will be done using EOS imaging system and a force plate'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient in orthodontic preparation for a surgical treatment,\n* age \\> 16 years\n\nExclusion Criteria:\n\n* postural disorder (scoliosis, history of spine surgery),\n* pregnancy or breastfeeding,\n* patients under guardianship'}, 'identificationModule': {'nctId': 'NCT03532828', 'briefTitle': 'Interaction Between Body Posture and Nocturnal Sleeping Disorders in Dysgnathic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Laboratoire de Biomécanique Georges Charpak'}, 'officialTitle': 'Nocturnal Respiratory Disorders Identification and Their Influence on the Body Posture and Breathing Synchronisation in Patients With Dentofacial Dysgnathia', 'orgStudyIdInfo': {'id': 'Dysmorphie / SAS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Polysomnography alone', 'description': 'A polygraphy will be performed in 70 patient to search for obstructive sleep apnea', 'interventionNames': ['Other: polysomnography']}, {'type': 'EXPERIMENTAL', 'label': 'Polysomnography and postural assesment', 'description': 'A polygraphy and a postural assesment will be performed in 30 patients', 'interventionNames': ['Other: polysomnography']}], 'interventions': [{'name': 'polysomnography', 'type': 'OTHER', 'otherNames': ['Postural evaluation'], 'description': 'Patients will have a polygraphy, a postural evaluation including Vicon system, EOS imaging, ang a force platform', 'armGroupLabels': ['Polysomnography alone', 'Polysomnography and postural assesment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Laboratoire de biomécanique Georges CHarpak', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoire de Biomécanique Georges Charpak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}