Rapid Maxillary Expansion for Residual Pediatric (ERMES)
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|ClinicalTrials.gov Identifier: NCT02947464|
Recruitment Status : Completed
First Posted : October 28, 2016
Last Update Posted : August 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Procedure: Standard clinical practice Device: Standard clinical practice + Rapid Maxillary Expansion||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Rapid Maxillary Expansion for Residual Pediatric Obstructive Sleep Apnea After Adenotonsillectomy: a Randomized Controlled Trial|
|Actual Study Start Date :||January 10, 2018|
|Actual Primary Completion Date :||May 30, 2021|
|Actual Study Completion Date :||June 30, 2021|
Active Comparator: Control
Standard clinical practice
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.
Standard clinical practice + Rapid Maxillary Expansion
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.
- Apnea Hypopnea Index (AHI) [ Time Frame: During sleep, an average of 10 hours ]Apnea Hypopnea Index (AHI) objectively measured by means of polysomnography.
- Sleep-related quality of life [ Time Frame: 2 years ]Quality of life as described by OSA-18 questionnaire.
- Craniofacial growth [ Time Frame: 2 years ]Craniofacial growth by lateral cephalometric radiograph.
- Dental arch growth [ Time Frame: 2 years ]Dental arch growth as described by Moorrees et al 1969.
- Adenotonsillar hypertrophy [ Time Frame: 2 years ]Adenotonsillar hypertrophy by nasal flexible fiberoptic endoscopy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947464
|Vitoria-Gasteiz, Alava, Spain, 01004|
|Principal Investigator:||Marcos Fernández-Barriales||Basque Health Service|