NCT03267927

Management of Obstructive Sleep Apnea (OSA) in Children and Maxillary and Mandibular Development

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 7 Years
• Healthy volunteers: Not accepted

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 (Yoobreath™) in patients with Obstructive Sleep Apnea (OAS). MGA™ and YooBreath™ constitute the Yookid system™.

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, 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.

Conditions

• Obstructive Sleep Apnea Syndrome

Interventions

Type	Name	Description
DEVICE	Rapid palatal expansion	Fixation of rapid palatal expansion from day 0 to day 60
DEVICE	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)
DEVICE	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)

Timeline

• Start date: 2017-11-05
• Primary completion: 2019-03-25
• Completion: 2019-03-25
• First posted: 2017-08-31
• Last updated: 2020-02-07

Locations

1 site across 1 country: France