Status:
COMPLETED
Management of Obstructive Sleep Apnea (OSA) in Children and Maxillary and Mandibular Development
Lead Sponsor:
Rennes University Hospital
Conditions:
Obstructive Sleep Apnea Syndrome
Eligibility:
All Genders
5-7 years
Phase:
NA
Brief Summary
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 (Yoobrea...
Detailed Description
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, detecti...
Eligibility Criteria
Inclusion
- 5 to 7 year-old children
- 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
- OSA associated to syndromic disorder and/or syndrome
- 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
Key Trial Info
Start Date :
November 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2019
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03267927
Start Date
November 5 2017
End Date
March 25 2019
Last Update
February 7 2020
Active Locations (1)
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1
CHU de Rennes
Rennes, France, 35033