Rapid Maxillary Expansion for Residual Pediatric

Obstructive Sleep Apnea Clinical Trial

— ERMES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02947464
• Other study ID #: ERMES
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2021
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• Standard clinical practice
Control weight will be started in obese children to decrease upper airway resistance and airway collapsibility. Close follow-up in order to detect comorbidities.

Device:
• Standard clinical practice + Rapid Maxillary Expansion
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.

Locations

Country	Name	City	State
Spain	Marcos Fernandez-Barriales	Vitoria-Gasteiz	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea Hypopnea Index (AHI)	Apnea Hypopnea Index (AHI) objectively measured by means of polysomnography.	During sleep, an average of 10 hours
Secondary	Sleep-related quality of life	Quality of life as described by OSA-18 questionnaire.	2 years
Secondary	Craniofacial growth	Craniofacial growth by lateral cephalometric radiograph.	2 years
Secondary	Dental arch growth	Dental arch growth as described by Moorrees et al 1969.	2 years
Secondary	Adenotonsillar hypertrophy	Adenotonsillar hypertrophy by nasal flexible fiberoptic endoscopy.	2 years