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Completed

NCT Number: NCT02947464

Rapid Maxillary Expansion for Residual Pediatric

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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Key information

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marcos Fernandez-Barriales

Vitoria-Gasteiz, Alava, 01004, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard clinical practice

Procedure

Control weight will be started in obese children to decrease upper airway resistance and airway collapsibility. Close follow-up in order to detect comorbidities.

Standard clinical practice + Rapid Maxillary Expansion

Device

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.

Primary outcomes

  1. Apnea Hypopnea Index (AHI)

    Time frame: During sleep, an average of 10 hours

    Apnea Hypopnea Index (AHI) objectively measured by means of polysomnography.

Secondary outcomes

  1. Sleep-related quality of life

    Time frame: 2 years

    Quality of life as described by OSA-18 questionnaire.

  2. Craniofacial growth

    Time frame: 2 years

    Craniofacial growth by lateral cephalometric radiograph.

  3. Dental arch growth

    Time frame: 2 years

    Dental arch growth as described by Moorrees et al 1969.

  4. Adenotonsillar hypertrophy

    Time frame: 2 years

    Adenotonsillar hypertrophy by nasal flexible fiberoptic endoscopy.

Sponsors and collaborators

Lead sponsor

Basque Health Service

Other Gov

Registry information

Official study title

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

Acronym: ERMES

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 28, 2016
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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