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

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rapid palatal expansion
MGA™ system
Yoobreath™ system
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring OSA, Polysomnography, Rapid palatal expansion, Mandibular advancement, Sleep position

Eligibility Criteria

5 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Rennes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient with OSA

Arm Description

Outcomes

Primary Outcome Measures

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™)
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™)

Secondary Outcome Measures

Sleep improvement
Measurement by polysomnography of desaturation index, micro arousal index and snoring index
Assessment of quality of sleep
Assessment of quality of sleep by a questionnaire
Assessment of quality of wakefulness
Assessment of quality of wakefulness by a questionnaire
Measurement of lengthening of mandibular body and ramus
Assessment of mandible development by an orthodontist using cephalometric analysis
Improvement of breathing
Improvement of breathing defined by polysomnography
Assessment of dental occlusion
Assessment of dental occlusion (clinical and using casts): diagnosis of Angle class
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)
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)
Assessment of duration of pain during rapid palatal expansion
Number of painful days after fixing of rapid palatal expansion
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)
Assessment of salivary disorders the morning on waking after using the MGA™ system
Assessment of salivary disorders the morning on waking by a questionnaire
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
Assessment of pain related to the semi-seated position
Assessment of pain related to the semi-seated position using a Visual Analogue Scale (VAS)
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
Assessment of risk of falling using the Yoobreath system™
Number of falls
Assessment of the compliance
Reporting of side effects

Full Information

First Posted
August 28, 2017
Last Updated
February 6, 2020
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03267927
Brief Title
Management of Obstructive Sleep Apnea (OSA) in Children and Maxillary and Mandibular Development
Acronym
SAOS
Official Title
Management of Obstructive Sleep Apnea (OSA) in Children and Maxillary and Mandibular Development
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 5, 2017 (Actual)
Primary Completion Date
March 25, 2019 (Actual)
Study Completion Date
March 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
OSA, Polysomnography, Rapid palatal expansion, Mandibular advancement, Sleep position

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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