Management of Obstructive Sleep Apnea (OSA) in Children and Maxillary and Mandibular Development
NCT ID: NCT03267927
Last Updated: 2020-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
4 participants
INTERVENTIONAL
2017-11-05
2019-03-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patient with OSA
Rapid palatal expansion
Fixation of rapid palatal expansion from day 0 to day 60
MGA™ system
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)
Yoobreath™ system
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)
Interventions
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Rapid palatal expansion
Fixation of rapid palatal expansion from day 0 to day 60
MGA™ system
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)
Yoobreath™ system
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)
Eligibility Criteria
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Inclusion Criteria
* Children with American Society of Anesthesiologists score (ASA) of 1 and 2
* Children with signs of OSA during examination and clinical exam
* Children with apnea-hypopnea index (AHI) from 1 to 5 (one to five sleep apnea / hour during PSG)
* Children with a class II division 1 angle malocclusion (at the canines level rotation center) and skeletal class II according to Delaire analysis
Exclusion Criteria
* Body/Mass Index (BMI) \> 97ème percentile according to development curves (obese children)
* Central sleep apnea
* Respiratory allergy
* Previous ear, nose and throat (ENT) surgery
* Hypertrophic tonsils needing surgery
* Adenoid hypertrophy needing surgery
* Patients with ankyloglossia
5 Years
7 Years
ALL
No
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Locations
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CHU de Rennes
Rennes, , France
Countries
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Other Identifiers
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35RC16_9851_SAOS
Identifier Type: -
Identifier Source: org_study_id
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