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Completed

NCT Number: NCT03267927

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

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™.

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Key information

Conditions

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

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Rennes

Rennes, 35033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid palatal expansion

Device

Fixation of rapid palatal expansion from day 0 to day 60

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)

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)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: SAOS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 31, 2017
Registry last updated
Feb 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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