Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT03451318
Status:
UNKNOWN
Last Update Posted:
2018-04-19
First Post:
2018-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-disciplinary Diagnosis and Treatment Process and Evaluation System for Children With Sleep Disordered Breathing and Malocclusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-01-16', 'releaseDate': '2024-11-28'}], 'estimatedResultsFirstSubmitDate': '2024-11-28'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D008310', 'term': 'Malocclusion'}], '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': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2020-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-17', 'studyFirstSubmitDate': '2018-02-07', 'studyFirstSubmitQcDate': '2018-02-23', 'lastUpdatePostDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Obstructive Apnea Index（OAI）/ Apnea Hypopnea Index （AHI） in PolySomnoGraphy （PSG）', 'timeFrame': 'change from baseline at 7 months,1 year & 2 years post-treatment', 'description': 'OAI/AHI (which are in negative correlation with oxygen saturation) decrease after treatment'}], 'secondaryOutcomes': [{'measure': 'Low arterial Oxygen Saturation （LSaO2） in PSG', 'timeFrame': 'change from baseline at 7 months,1 year & 2 years post-treatment', 'description': 'LSaO2 increase after treatment'}, {'measure': 'Airway volume change as shown on Cone Beam Computer Tomography (CBCT)', 'timeFrame': 'change from baseline at 7 months post-treatment', 'description': 'Airway volume increase after treatment'}, {'measure': 'ANB, Frankfort plane- Mandibular plane Angle (FMA) measurement using X-ray cephalometrics.', 'timeFrame': 'change from baseline at 7 months,1 year & 2 years post-treatment', 'description': 'ANB \\& FMA (face development indicators) become normal after treatment'}, {'measure': 'Assessment of subjective efficacy by using a "questionnaire on children\'s sleep symptoms"', 'timeFrame': 'change from baseline at 7 months,1 year & 2 years post-treatment', 'description': 'Sleep quality improve after treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion']}, 'referencesModule': {'references': [{'pmid': '32605655', 'type': 'DERIVED', 'citation': 'Li Y, Wu J, Guo J, Yu L, Wang J, Li X, Xu S, Zhu M, Feng J, Liu Y. The efficacy of different treatment approaches for pediatric OSAHS patients with mandibular retrognathia: study protocol for a multicenter randomized controlled trial. Trials. 2020 Jun 30;21(1):595. doi: 10.1186/s13063-020-04398-9.'}]}, 'descriptionModule': {'briefSummary': "The aim of this study is to compare the efficacy and safety of drug therapy, tonsillar adenoidectomy only, orthodontic treatment only and tonsillar adenoidectomy plus orthodontic treatment in children with obstructive sleep apnea hypopnea syndrome (OSAHS) and malocclusion.\n\nIn this study, we hope to improve children's OSAH in function, three-dimensional shape and subjective and objective symptoms of sleep breathing through tonsillar adenoidectomy plus orthodontic treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed as mild to moderate OSAHS\n2. Tonsil and/or adenoid hypertrophy\n3. Narrow dental arch and / or mandibular retrusion (ANB value≥ 4.5)\n4. The guardian / child can understand the study and sign the informed consent\n\nExclusion Criteria:\n\n1. Patients with nasal obstruction disease\n2. The pathological obesity\n3. Patients with systemic disease\n4. Patient with central sleep apnea/hypopnea syndrome'}, 'identificationModule': {'nctId': 'NCT03451318', 'briefTitle': 'Multi-disciplinary Diagnosis and Treatment Process and Evaluation System for Children With Sleep Disordered Breathing and Malocclusion', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Stomotological Hospital'}, 'officialTitle': 'A Multicenter Study of Establishing the Multi-disciplinary Cooperative Diagnosis and Treatment Process and Evaluation System for Children With Sleep Disordered Breathing and Malocclusion', 'orgStudyIdInfo': {'id': '16CR2044B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'drug therapy', 'description': 'Nasonex(mometasone furoate),1 spray,QD (Quaque Die in Latin),for 3 months.', 'interventionNames': ['Drug: Mometasone Furoate Nasal Spray']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tonsillar adenoidectomy', 'description': 'tonsillar adenoidectomy', 'interventionNames': ['Procedure: tonsillar adenoidectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'orthodontic treatment', 'description': 'Apply Twin-block appliance combined with maxillary expander', 'interventionNames': ['Procedure: Maxillary expander plus Twin-Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tonsillar adenoidectomy plus orthodontic treatment', 'description': 'Apply Twin-block appliance combined with maxillary expander one month after tonsillar adenoidectomy .', 'interventionNames': ['Procedure: tonsillar adenoidectomy', 'Procedure: Maxillary expander plus Twin-Block']}], 'interventions': [{'name': 'Mometasone Furoate Nasal Spray', 'type': 'DRUG', 'description': 'Mometasone Furoate Nasal Spray NASONEX', 'armGroupLabels': ['drug therapy']}, {'name': 'tonsillar adenoidectomy', 'type': 'PROCEDURE', 'description': 'tonsillar adenoidectomy', 'armGroupLabels': ['tonsillar adenoidectomy', 'tonsillar adenoidectomy plus orthodontic treatment']}, {'name': 'Maxillary expander plus Twin-Block', 'type': 'PROCEDURE', 'description': 'Twin-block appliance combined with maxillary expander', 'armGroupLabels': ['orthodontic treatment', 'tonsillar adenoidectomy plus orthodontic treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200001', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuanyuan Li, Doctor', 'role': 'CONTACT', 'email': 'liyuanyuan831@sina.com', 'phone': '18817367760'}, {'name': 'Yuehua Liu, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai Stomotological Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yuanyuan Li, Doctor', 'role': 'CONTACT', 'email': 'liyuanyuan831@sina.com', 'phone': '86-18817367760'}, {'name': 'Huanbqing Shan', 'role': 'CONTACT', 'email': '362911628@qq.com', 'phone': '86-13564158276'}], 'overallOfficials': [{'name': 'Yuehua Liu, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthodonitcs,Shanghai Stomatological Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Stomotological Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University", 'class': 'OTHER'}, {'name': "Shanghai Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-11-28', 'type': 'RELEASE'}, {'date': '2025-01-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Shanghai Stomotological Hospital'}}}}