Clinical trial NCT03267927: Management of Obstructive Sleep Apnea (OSA) in Children and Maxillary and Mandibular Development
Official title: Management of Obstructive Sleep Apnea (OSA) in Children and Maxillary and Mandibular Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: OSA
Polysomnography
Rapid palatal expansion
Mandibular advancement
Sleep position
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 4
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
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
Secondary outcomes:
measure: Sleep improvement
timeFrame: Day -7, day 180
measure: Assessment of quality of sleep
timeFrame: Day 180
measure: Assessment of quality of wakefulness
timeFrame: Day 180
measure: Measurement of lengthening of mandibular body and ramus
timeFrame: Day -7, day 180
measure: Improvement of breathing
timeFrame: Day -7, day 180
measure: Assessment of dental occlusion
timeFrame: Day -7, day 180
measure: Assessement by the child and the parents of the treatment and the devices used
timeFrame: Day 180
measure: Assessment of intensity of pain during rapid palatal expansion
timeFrame: Day 60
measure: Assessment of duration of pain during rapid palatal expansion
timeFrame: Day 60
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
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
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
measure: Assessment of pain related to the semi-seated position
timeFrame: Day 15, day 60, day 90, day 120, day 150, day 180
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
measure: Assessment of risk of falling using the Yoobreath system™
timeFrame: Day 15, day 60, day 90, day 120, day 150, day 180
measure: Assessment of the compliance
timeFrame: Day 0, day 15, day 60, day 90, day 120, day 150, day 180
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References: