Rapid Maxillary Expansion for Residual Pediatric (ERMES)

Basque Health Service

Status

Completed

Conditions

Obstructive Sleep Apnea

Treatments

Device: Standard clinical practice + Rapid Maxillary Expansion

Procedure: Standard clinical practice

Study type

Interventional

Funder types

Other

Identifiers

NCT02947464

ERMES

Details and patient eligibility

About

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

Full 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.

Enrollment

16 patients

Sex

All

Ages

4 to 9 years old

Volunteers

Accepts Healthy Volunteers

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.