Rapid Maxillary Expansion for Residual Pediatric

Study Overview
=================
Brief Summary
-----------------
Randomized Controlled Trial comparing Rapid Maxillary Expansion with Standard Clinical Practice in patients with residual pediatric Obstructive Sleep Apnea Syndrome after adenotonsillectomy.

Detailed 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.

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

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Procedure: Standard clinical practice
* Device: Standard clinical practice + Rapid Maxillary Expansion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children (boys and girls) between 4 and 9 years of age. Residual OSAS after adenotonsillectomy (described as an Apnea Hypopnea Index over 3 objectively measured by means of polysomnography). Rapid maxillary expansion indication. Parents or tutors sign Informed Consent. Exclusion Criteria: Craniofacial syndromes or neurologic disease diagnosis. Adenoid residual hypertrophy occluding >50% nasal airway as measured by means of nasal flexible fiberoptic endoscopy and or tonsillar residual hypertrophy >2 as measured by direct intraoral physical exam.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 9 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Standard clinical practice | Procedure: Standard clinical practice<br>* Control weight will be started in obese children to decrease upper airway resistance and airway collapsibility. Close follow-up in order to detect comorbidities.<br>|
| Experimental: Intervention<br>Standard clinical practice + Rapid Maxillary Expansion | Device: Standard clinical practice + Rapid Maxillary Expansion<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |