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

NCT03267927 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2020-02-07

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-05
Primary Completion
2019-03-25
Completion
2019-03-25

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03267927 on ClinicalTrials.gov