Rapid Maxillary Expansion for Residual Pediatric

NCT02947464 | Completed DMC

• 1 other identifier: ERMES
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Apnea Hypopnea Index (AHI)

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

  During sleep, an average of 10 hours

Secondary Outcomes (4)

• Sleep-related quality of life

  2 years

• Craniofacial growth

  2 years

• Dental arch growth

  2 years

• Adenotonsillar hypertrophy

  2 years

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard clinical practice

Procedure: Standard clinical practice

Intervention

EXPERIMENTAL

Standard clinical practice + Rapid Maxillary Expansion

Device: Standard clinical practice + Rapid Maxillary Expansion

Interventions

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.

Control

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.

Intervention

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Basque Health Service: lead

Study Sites (1)

Marcos Fernandez-Barriales

Vitoria-Gasteiz, Alava, 01004, Spain

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Marcos Fernández-Barriales

  Basque Health Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Doctor

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: October 28, 2016
• Study Start: January 10, 2018
• Primary Completion: May 30, 2021
• Study Completion: June 30, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)