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

Obstructive Sleep Apnea Syndrome Clinical Trial

— SAOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03267927
• Other study ID #: 35RC16_9851_SAOS
• Status: Completed
• Phase: N/A
• Start date: November 5, 2017
• Est. completion date: March 25, 2019

Study information

• Verified date: February 2020
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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™.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: March 25, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• 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)

Locations

Country	Name	City	State
France	CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Sleep improvement	Measurement by polysomnography of desaturation index, micro arousal index and snoring index	Day -7, day 180
Secondary	Assessment of quality of sleep	Assessment of quality of sleep by a questionnaire	Day 180
Secondary	Assessment of quality of wakefulness	Assessment of quality of wakefulness by a questionnaire	Day 180
Secondary	Measurement of lengthening of mandibular body and ramus	Assessment of mandible development by an orthodontist using cephalometric analysis	Day -7, day 180
Secondary	Improvement of breathing	Improvement of breathing defined by polysomnography	Day -7, day 180
Secondary	Assessment of dental occlusion	Assessment of dental occlusion (clinical and using casts): diagnosis of Angle class	Day -7, day 180
Secondary	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
Secondary	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
Secondary	Assessment of duration of pain during rapid palatal expansion	Number of painful days after fixing of rapid palatal expansion	Day 60
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Assessment of risk of falling using the Yoobreath system™	Number of falls	Day 15, day 60, day 90, day 120, day 150, day 180
Secondary	Assessment of the compliance	Reporting of side effects	Day 0, day 15, day 60, day 90, day 120, day 150, day 180