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Randomized Controlled Trial comparing Rapid Maxillary Expansion with Standard Clinical Practice in patients with residual pediatric Obstructive Sleep Apnea Syndrome after adenotonsillectomy.
Cure rate of pediatric Obstructive Sleep Apnea Syndrome (OSAS) after gold-standard-treatment adenotonsillectomy is 50-80%. Treatment alternatives are scarce, poorly effective and based upon low scientific evidence. This means one out of five patients will remain exposed to the well-known neurocognitive, behavioral and quality of life adverse effects of disease.
Rapid Maxillary Expansion, an orthopaedic-orthodontic treatment of pediatric malocclusion, has recently shown promising results in the treatment of pediatric OSAS based upon its effect on craniofacial and upper airway growth, usually limited in these patients.
The investigators propose a randomized, prospective, controlled trial in patients with Pediatric OSAS non-responding to adenotonsillectomy. The aim of the study is to enhance the treatment success rate avoiding morbimortality associated to disease persistence during childhood and development during adult life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Standard clinical practice |
|
| Intervention | Experimental | Standard clinical practice + Rapid Maxillary Expansion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard clinical practice | Procedure | Control weight will be started in obese children to decrease upper airway resistance and airway collapsibility. Close follow-up in order to detect comorbidities. |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea Hypopnea Index (AHI) | Apnea Hypopnea Index (AHI) objectively measured by means of polysomnography. | During sleep, an average of 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep-related quality of life | Quality of life as described by OSA-18 questionnaire. | 2 years |
| Craniofacial growth | Craniofacial growth by lateral cephalometric radiograph. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcos FernƔndez-Barriales | Basque Health Service | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marcos Fernandez-Barriales | Vitoria-Gasteiz | Alava | 01004 | Spain |
IPD will be made available on reasonable request after completion of the trial
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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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| Standard clinical practice + Rapid Maxillary Expansion | Device | Mid-palatal suture osteogenic distraction delivered through a self-activated acrylic intraoral device custom-fit into the children“s palate and maxillary posterior teeth providing a transverse expansion of the dentofacial skeleton. |
|
| 2 years |
| Dental arch growth | Dental arch growth as described by Moorrees et al 1969. | 2 years |
| Adenotonsillar hypertrophy | Adenotonsillar hypertrophy by nasal flexible fiberoptic endoscopy. | 2 years |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |