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

NCT03267927 | Completed

• 1 other identifier: 35RC16_9851_SAOS
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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™.

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

OSA; Polysomnography; Rapid palatal expansion; Mandibular advancement; Sleep position

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• Sleep improvement

  Day -7, day 180

• Assessment of quality of sleep

  Day 180

• Assessment of quality of wakefulness

  Day 180

• Measurement of lengthening of mandibular body and ramus

  Day -7, day 180

• Improvement of breathing

  Day -7, day 180

Study Arms (1)

Patient with OSA

EXPERIMENTAL

Device: Rapid palatal expansion; Device: MGA™ system; Device: Yoobreath™ system

Interventions

Rapid palatal expansion DEVICE

Fixation of rapid palatal expansion from day 0 to day 60

Patient with OSA

MGA™ system DEVICE

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)

Patient with OSA

Yoobreath™ system DEVICE

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)

Patient with OSA

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: August 31, 2017
• Study Start: November 5, 2017
• Primary Completion: March 25, 2019
• Study Completion: March 25, 2019
• Last Updated: February 7, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)