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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™.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with OSA | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid palatal expansion | Device | Fixation of rapid palatal expansion from day 0 to day 60 |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep improvement | Measurement by polysomnography of desaturation index, micro arousal index and snoring index | Day -7, day 180 |
| Assessment of quality of sleep | Assessment of quality of sleep by a questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Rennes | Rennes | 35033 | France |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| 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) |
|
| Day 180 |
| Assessment of quality of wakefulness | Assessment of quality of wakefulness by a questionnaire | Day 180 |
| Measurement of lengthening of mandibular body and ramus | Assessment of mandible development by an orthodontist using cephalometric analysis | Day -7, day 180 |
| Improvement of breathing | Improvement of breathing defined by polysomnography | Day -7, day 180 |
| Assessment of dental occlusion | Assessment of dental occlusion (clinical and using casts): diagnosis of Angle class | Day -7, day 180 |
| 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) | Day 180 |
| 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) | Day 60 |
| Assessment of duration of pain during rapid palatal expansion | Number of painful days after fixing of rapid palatal expansion | Day 60 |
| 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) | Day 60, day 90, day 120, day 150, day 180 |
| Assessment of salivary disorders the morning on waking after using the MGA™ system | Assessment of salivary disorders the morning on waking by a questionnaire | Day 60, day 90, day 120, day 150, day 180 |
| 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 | Day 60, day 90, day 120, day 150, day 180 |
| Assessment of pain related to the semi-seated position | Assessment of pain related to the semi-seated position using a Visual Analogue Scale (VAS) | Day 15, day 60, day 90, day 120, day 150, day 180 |
| 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 | Day 15, day 60, day 90, day 120, day 150, day 180 |
| Assessment of risk of falling using the Yoobreath system™ | Number of falls | Day 15, day 60, day 90, day 120, day 150, day 180 |
| Assessment of the compliance | Reporting of side effects | Day 0, day 15, day 60, day 90, day 120, day 150, day 180 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |