Rapid Maxillary Expansion for Residual Pediatric

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Standard clinical practice + Rapid Maxillary Expansion; Procedure: Standard clinical practice

• Registration Number: NCT02947464
• Lead Sponsor: Basque Health Service

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.

Study Timeline

• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-10-28
• Study Start: 2018-01-10
• Primary Completion: 2021-05-30
• Study Completion: 2021-06-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Standard clinical practice + Rapid Maxillary Expansion	Standard clinical practice + Rapid Maxillary Expansion
Control	Standard clinical practice	Standard clinical practice

Primary Outcome Measures

Name	Time	Method
Apnea Hypopnea Index (AHI)	During sleep, an average of 10 hours	Apnea Hypopnea Index (AHI) objectively measured by means of polysomnography.

Secondary Outcome Measures

Name	Time	Method
Craniofacial growth	2 years	Craniofacial growth by lateral cephalometric radiograph.
Adenotonsillar hypertrophy	2 years	Adenotonsillar hypertrophy by nasal flexible fiberoptic endoscopy.
Sleep-related quality of life	2 years	Quality of life as described by OSA-18 questionnaire.
Dental arch growth	2 years	Dental arch growth as described by Moorrees et al 1969.

Trial Locations

Locations (1)

Marcos Fernandez-Barriales; 🇪🇸 Vitoria-Gasteiz, Alava, Spain