Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-01-10 @ 1:48 AM
Study NCT ID:
NCT03267927
Status:
COMPLETED
Last Update Posted:
2020-02-07
First Post:
2017-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Obstructive Sleep Apnea (OSA) in Children and Maxillary and Mandibular Development
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-06', 'studyFirstSubmitDate': '2017-08-28', 'studyFirstSubmitQcDate': '2017-08-28', 'lastUpdatePostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment in 5 to 7 year-old children the efficacy on OSA (removal or decrease of apnea/hypopnea) of Rapid Palatal Expansion combined with advancement using a mandibular advancement appliance (MGA™)', 'timeFrame': 'Day 180'}, {'measure': 'Assessment in 5 to 7 year-old children the efficacy on OSA (removal or decrease of apnea/hypopnea) of Rapid Palatal Expansion combined with a device allowing a semi-seated sleeping position (YooBreath™)', 'timeFrame': 'Day 180'}], 'secondaryOutcomes': [{'measure': 'Sleep improvement', 'timeFrame': 'Day -7, day 180', 'description': 'Measurement by polysomnography of desaturation index, micro arousal index and snoring index'}, {'measure': 'Assessment of quality of sleep', 'timeFrame': 'Day 180', 'description': 'Assessment of quality of sleep by a questionnaire'}, {'measure': 'Assessment of quality of wakefulness', 'timeFrame': 'Day 180', 'description': 'Assessment of quality of wakefulness by a questionnaire'}, {'measure': 'Measurement of lengthening of mandibular body and ramus', 'timeFrame': 'Day -7, day 180', 'description': 'Assessment of mandible development by an orthodontist using cephalometric analysis'}, {'measure': 'Improvement of breathing', 'timeFrame': 'Day -7, day 180', 'description': 'Improvement of breathing defined by polysomnography'}, {'measure': 'Assessment of dental occlusion', 'timeFrame': 'Day -7, day 180', 'description': 'Assessment of dental occlusion (clinical and using casts): diagnosis of Angle class'}, {'measure': 'Assessement by the child and the parents of the treatment and the devices used', 'timeFrame': 'Day 180', 'description': 'Assessement by the child and the parents of the treatment and the devices used by two questionnaires (one for parents and one for the child)'}, {'measure': 'Assessment of intensity of pain during rapid palatal expansion', 'timeFrame': 'Day 60', 'description': 'Assessment of intensity of pain after fixing of rapid palatal expansion using a Visual Analogue Scale (VAS)'}, {'measure': 'Assessment of duration of pain during rapid palatal expansion', 'timeFrame': 'Day 60', 'description': 'Number of painful days after fixing of rapid palatal expansion'}, {'measure': 'Assessment of intensity of dental pain the morning on waking after using the MGA™ system', 'timeFrame': 'Day 60, day 90, day 120, day 150, day 180', 'description': 'Assessment of intensity of dental pain the morning on waking using a Visual Analogue Scale (VAS)'}, {'measure': 'Assessment of salivary disorders the morning on waking after using the MGA™ system', 'timeFrame': 'Day 60, day 90, day 120, day 150, day 180', 'description': 'Assessment of salivary disorders the morning on waking by a questionnaire'}, {'measure': 'Assessment of duration of dental pain the morning on waking after using the MGA™ system', 'timeFrame': 'Day 60, day 90, day 120, day 150, day 180', 'description': 'Number of painful days at the mandible the morning on waking'}, {'measure': 'Assessment of pain related to the semi-seated position', 'timeFrame': 'Day 15, day 60, day 90, day 120, day 150, day 180', 'description': 'Assessment of pain related to the semi-seated position using a Visual Analogue Scale (VAS)'}, {'measure': 'Assessment of disorders in falling asleep and sleep quality (micro arousals)', 'timeFrame': 'Day 15, day 60, day 90, day 120, day 150, day 180', 'description': 'Assessment of disorders in falling asleep and sleep quality (micro arousals) by a questionnaire'}, {'measure': 'Assessment of risk of falling using the Yoobreath system™', 'timeFrame': 'Day 15, day 60, day 90, day 120, day 150, day 180', 'description': 'Number of falls'}, {'measure': 'Assessment of the compliance', 'timeFrame': 'Day 0, day 15, day 60, day 90, day 120, day 150, day 180', 'description': 'Reporting of side effects'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OSA', 'Polysomnography', 'Rapid palatal expansion', 'Mandibular advancement', 'Sleep position'], 'conditions': ['Obstructive Sleep Apnea Syndrome']}, 'descriptionModule': {'briefSummary': 'Assessment of the association of maxillary expansion using a rapid palatal expansion, use of a mandibular advancement appliance (MGA™) and of a device allowing sleep in a semi-seated position (Yoobreath™) in patients with Obstructive Sleep Apnea (OAS). MGA™ and YooBreath™ constitute the Yookid system™.', 'detailedDescription': 'Obstructive Sleep Apnea syndrome (OSA) shows a 10% morbidity rate in children with a higher rate between the ages of 3 and 5. Generally speaking, its prevalence is underestimated. Furthermore, detecting OSA remains difficult due to its particular physiopathology. The decrease in nasopharyngeal airway dimensions is the most common etiology. This decrease is related to soft tissues as well as maxillomandibular abnormalities. The aim of the study is to show that reducing sleep apnea in children remains possible when inducing rapid palatal expansion and mandibular advancement using the Yookid™ system. The Yookid™ system associates a mandibular advancement appliance and repositioning of the patient during sleep.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 5 to 7 year-old children\n* Children with American Society of Anesthesiologists score (ASA) of 1 and 2\n* Children with signs of OSA during examination and clinical exam\n* Children with apnea-hypopnea index (AHI) from 1 to 5 (one to five sleep apnea / hour during PSG)\n* Children with a class II division 1 angle malocclusion (at the canines level rotation center) and skeletal class II according to Delaire analysis\n\nExclusion Criteria:\n\n* OSA associated to syndromic disorder and/or syndrome\n* Body/Mass Index (BMI) \\> 97ème percentile according to development curves (obese children)\n* Central sleep apnea\n* Respiratory allergy\n* Previous ear, nose and throat (ENT) surgery\n* Hypertrophic tonsils needing surgery\n* Adenoid hypertrophy needing surgery\n* Patients with ankyloglossia'}, 'identificationModule': {'nctId': 'NCT03267927', 'acronym': 'SAOS', 'briefTitle': 'Management of Obstructive Sleep Apnea (OSA) in Children and Maxillary and Mandibular Development', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Management of Obstructive Sleep Apnea (OSA) in Children and Maxillary and Mandibular Development', 'orgStudyIdInfo': {'id': '35RC16_9851_SAOS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient with OSA', 'interventionNames': ['Device: Rapid palatal expansion', 'Device: MGA™ system', 'Device: Yoobreath™ system']}], 'interventions': [{'name': 'Rapid palatal expansion', 'type': 'DEVICE', 'description': 'Fixation of rapid palatal expansion from day 0 to day 60', 'armGroupLabels': ['Patient with OSA']}, {'name': 'MGA™ system', 'type': 'DEVICE', 'description': 'Use of a mandibular advancement Appliance during the night from day 60 to day 180 (end of treatment from day 120 if Angle Class I is obtained)', 'armGroupLabels': ['Patient with OSA']}, {'name': 'Yoobreath™ system', 'type': 'DEVICE', 'description': 'Use of a device allowing sleep in a semi-seated position during the night from day 15 to day 180 (end of treatment from day 120 if Angle Class I is obtained)', 'armGroupLabels': ['Patient with OSA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}