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

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™.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea Syndrome
• Intervention / Treatment: Device: Rapid palatal expansion; Device: MGA™ system; Device: Yoobreath™ 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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • CHU de Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patient with OSA

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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™)	Day 180
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™)	Day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep improvement	Measurement by polysomnography of desaturation index, micro arousal index and snoring index	Day -7, day 180
Assessment of quality of sleep	Assessment of quality of sleep by a questionnaire	Day 180
Assessment of quality of wakefulness	Assessment of quality of wakefulness by a questionnaire	Day 180
Measurement of lengthening of mandibular body and ramus	Assessment of mandible development by an orthodontist using cephalometric analysis	Day -7, day 180
Improvement of breathing	Improvement of breathing defined by polysomnography	Day -7, day 180
Assessment of dental occlusion	Assessment of dental occlusion (clinical and using casts): diagnosis of Angle class	Day -7, day 180
Assessement by the child and the parents of the treatment and the devices used	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)	Day 180
Assessment of intensity of pain during rapid palatal expansion	Assessment of intensity of pain after fixing of rapid palatal expansion using a Visual Analogue Scale (VAS)	Day 60
Assessment of duration of pain during rapid palatal expansion	Number of painful days after fixing of rapid palatal expansion	Day 60
Assessment of intensity of dental pain the morning on waking after using the MGA™ system	Assessment of intensity of dental pain the morning on waking using a Visual Analogue Scale (VAS)	Day 60, day 90, day 120, day 150, day 180
Assessment of salivary disorders the morning on waking after using the MGA™ system	Assessment of salivary disorders the morning on waking by a questionnaire	Day 60, day 90, day 120, day 150, day 180
Assessment of duration of dental pain the morning on waking after using the MGA™ system	Number of painful days at the mandible the morning on waking	Day 60, day 90, day 120, day 150, day 180
Assessment of pain related to the semi-seated position	Assessment of pain related to the semi-seated position using a Visual Analogue Scale (VAS)	Day 15, day 60, day 90, day 120, day 150, day 180
Assessment of disorders in falling asleep and sleep quality (micro arousals)	Assessment of disorders in falling asleep and sleep quality (micro arousals) by a questionnaire	Day 15, day 60, day 90, day 120, day 150, day 180
Assessment of risk of falling using the Yoobreath system™	Number of falls	Day 15, day 60, day 90, day 120, day 150, day 180
Assessment of the compliance	Reporting of side effects	Day 0, day 15, day 60, day 90, day 120, day 150, day 180

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2017
• Primary Completion (Actual): March 25, 2019
• Study Completion (Actual): March 25, 2019

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 31, 2017

Study Record Updates

• Last Update Posted (Actual): February 7, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: OSA; Polysomnography; Mandibular advancement; Rapid palatal expansion; Sleep position
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 35RC16_9851_SAOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No