Marcos Fernandez-Barriales
Vitoria-Gasteiz, Alava, 01004, Spain
NCT Number: NCT02947464
Randomized Controlled Trial comparing Rapid Maxillary Expansion with Standard Clinical Practice in patients with residual pediatric Obstructive Sleep Apnea Syndrome after adenotonsillectomy.
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Notify Me4 year–9 year
All sexes
Interventional
Not applicable
Vitoria-Gasteiz, Alava, 01004, Spain
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Control weight will be started in obese children to decrease upper airway resistance and airway collapsibility. Close follow-up in order to detect comorbidities.
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.
Time frame: During sleep, an average of 10 hours
Apnea Hypopnea Index (AHI) objectively measured by means of polysomnography.
Time frame: 2 years
Quality of life as described by OSA-18 questionnaire.
Time frame: 2 years
Craniofacial growth by lateral cephalometric radiograph.
Time frame: 2 years
Dental arch growth as described by Moorrees et al 1969.
Time frame: 2 years
Adenotonsillar hypertrophy by nasal flexible fiberoptic endoscopy.
Basque Health Service
Other Gov
Rapid Maxillary Expansion for Residual Pediatric Obstructive Sleep Apnea After Adenotonsillectomy: a Randomized Controlled Trial
Acronym: ERMES
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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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