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

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ClinicalTrials.gov Identifier: NCT03267927
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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™.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Syndrome Device: Rapid palatal expansion Device: MGA™ system Device: Yoobreath™ system Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Obstructive Sleep Apnea (OSA) in Children and Maxillary and Mandibular Development
Actual Study Start Date : November 5, 2017
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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)




Primary Outcome Measures :
  1. 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 ]
  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 a device allowing a semi-seated sleeping position (YooBreath™) [ Time Frame: Day 180 ]

Secondary Outcome Measures :
  1. Sleep improvement [ Time Frame: Day -7, day 180 ]
    Measurement by polysomnography of desaturation index, micro arousal index and snoring index

  2. Assessment of quality of sleep [ Time Frame: Day 180 ]
    Assessment of quality of sleep by a questionnaire

  3. Assessment of quality of wakefulness [ Time Frame: Day 180 ]
    Assessment of quality of wakefulness by a questionnaire

  4. Measurement of lengthening of mandibular body and ramus [ Time Frame: Day -7, day 180 ]
    Assessment of mandible development by an orthodontist using cephalometric analysis

  5. Improvement of breathing [ Time Frame: Day -7, day 180 ]
    Improvement of breathing defined by polysomnography

  6. Assessment of dental occlusion [ Time Frame: Day -7, day 180 ]
    Assessment of dental occlusion (clinical and using casts): diagnosis of Angle class

  7. Assessement by the child and the parents of the treatment and the devices used [ Time Frame: Day 180 ]
    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)

  8. Assessment of intensity of pain during rapid palatal expansion [ Time Frame: Day 60 ]
    Assessment of intensity of pain after fixing of rapid palatal expansion using a Visual Analogue Scale (VAS)

  9. Assessment of duration of pain during rapid palatal expansion [ Time Frame: Day 60 ]
    Number of painful days after fixing of rapid palatal expansion

  10. Assessment of intensity of dental pain the morning on waking after using the MGA™ system [ Time Frame: Day 60, day 90, day 120, day 150, day 180 ]
    Assessment of intensity of dental pain the morning on waking using a Visual Analogue Scale (VAS)

  11. Assessment of salivary disorders the morning on waking after using the MGA™ system [ Time Frame: Day 60, day 90, day 120, day 150, day 180 ]
    Assessment of salivary disorders the morning on waking by a questionnaire

  12. Assessment of duration of dental pain the morning on waking after using the MGA™ system [ Time Frame: Day 60, day 90, day 120, day 150, day 180 ]
    Number of painful days at the mandible the morning on waking

  13. Assessment of pain related to the semi-seated position [ Time Frame: Day 15, day 60, day 90, day 120, day 150, day 180 ]
    Assessment of pain related to the semi-seated position using a Visual Analogue Scale (VAS)

  14. Assessment of disorders in falling asleep and sleep quality (micro arousals) [ Time Frame: Day 15, day 60, day 90, day 120, day 150, day 180 ]
    Assessment of disorders in falling asleep and sleep quality (micro arousals) by a questionnaire

  15. Assessment of risk of falling using the Yoobreath system™ [ Time Frame: Day 15, day 60, day 90, day 120, day 150, day 180 ]
    Number of falls

  16. Assessment of the compliance [ Time Frame: Day 0, day 15, day 60, day 90, day 120, day 150, day 180 ]
    Reporting of side effects



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Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267927


Contacts
Contact: Jean-Louis Sixou, MD, PhD 02.99.38.84.22 jean-louis.sixou@chu-rennes.fr

Locations
France
CHU de Rennes Recruiting
Rennes, France, 35033
Contact: Jean-Louis Sixou, MD, PhD    02 99 38 84 22    jean-louis.sixou@chu-rennes.fr   
Sub-Investigator: Philippe Moisdon, MD         
Sponsors and Collaborators
Rennes University Hospital

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03267927     History of Changes
Other Study ID Numbers: 35RC16_9851_SAOS
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rennes University Hospital:
OSA
Polysomnography
Rapid palatal expansion
Mandibular advancement
Sleep position

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases