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Rapid Maxillary Expansion for Residual Pediatric — ERMES  

Obstructive Sleep Apnea Clinical Trial

Official title:
Rapid Maxillary Expansion for Residual Pediatric Obstructive Sleep Apnea After Adenotonsillectomy: a Randomized Controlled Trial

Clinical Trial Summary

Randomized Controlled Trial comparing Rapid Maxillary Expansion with Standard Clinical Practice in patients with residual pediatric Obstructive Sleep Apnea Syndrome after adenotonsillectomy.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02947464
Study type Interventional
Source Basque Health Service
Contact
Status Completed
Phase N/A
Start date January 10, 2018
Completion date June 30, 2021
View Details
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