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Rapid Maxillary Expansion for Residual Pediatric (ERMES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02947464
Recruitment Status : Completed
First Posted : October 28, 2016
Last Update Posted : August 20, 2021
Sponsor:
Information provided by (Responsible Party):
MBarriales, Basque Health Service

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

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Procedure: Standard clinical practice Device: Standard clinical practice + Rapid Maxillary Expansion Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Arm Intervention/treatment
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.
Experimental: Intervention
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Spain
Marcos Fernandez-Barriales
Vitoria-Gasteiz, Alava, Spain, 01004
Sponsors and Collaborators
Basque Health Service
Investigators
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Principal Investigator: Marcos Fernández-Barriales Basque Health Service
More Information
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Responsible Party: MBarriales, Registered Doctor, Basque Health Service
ClinicalTrials.gov Identifier: NCT02947464    
Other Study ID Numbers: ERMES
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be made available on reasonable request after completion of the trial

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases