Obstructive Sleep Apnea Syndrome
Conditions
Keywords
OSA, Polysomnography, Rapid palatal expansion, Mandibular advancement, Sleep position
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.
Interventions
DEVICERapid palatal expansion
Fixation of rapid palatal expansion from day 0 to day 60
DEVICEMGA™ 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)
DEVICEYoobreath™ 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
Rennes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 7 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Assessment of quality of wakefulness | Day 180 | Assessment of quality of wakefulness by a questionnaire |
| Measurement of lengthening of mandibular body and ramus | Day -7, day 180 | Assessment of mandible development by an orthodontist using cephalometric analysis |
| Improvement of breathing | Day -7, day 180 | Improvement of breathing defined by polysomnography |
| Assessment of dental occlusion | Day -7, day 180 | 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 | 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) |
| Assessment of intensity of pain during rapid palatal expansion | Day 60 | 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 | Day 60 | Number of painful days after fixing of rapid palatal expansion |
| Sleep improvement | Day -7, day 180 | Measurement by polysomnography of desaturation index, micro arousal index and snoring index |
| Assessment of salivary disorders the morning on waking after using the MGA™ system | Day 60, day 90, day 120, day 150, day 180 | 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 | Day 60, day 90, day 120, day 150, day 180 | Number of painful days at the mandible the morning on waking |
| Assessment of pain related to the semi-seated position | 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) |
| Assessment of disorders in falling asleep and sleep quality (micro arousals) | 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 |
| Assessment of risk of falling using the Yoobreath system™ | Day 15, day 60, day 90, day 120, day 150, day 180 | Number of falls |
| Assessment of the compliance | Day 0, day 15, day 60, day 90, day 120, day 150, day 180 | Reporting of side effects |
| Assessment of intensity of dental pain the morning on waking after using the MGA™ system | 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) |
| Assessment of quality of sleep | Day 180 | Assessment of quality of sleep by a questionnaire |
Countries
France
Outcome results
None listed