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Changes in Polysomnography and Rhinomanometry Parameters After Rapid Maxillary Expansion or Adenotonsilectomy in Children With Obstructive Sleep Apnea

NCT07069543 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-07-16

No results posted yet for this study

Summary

Adenotonsillectomy (AT) is considered the most effective and the standard treatment for Obstructive Sleep Apnea (OSA) in children. Since maxillary hypoplasia is a risk factor for OSA, Rapid Maxillary Expansion (RME) has been be considered as a complementary treatment in selected cases,improving the OSA. To compare changes in polysomnography (PSG) and in anterior active rhinomanometry (AAR) in children diagnosed with OSA, treated with RME or AT.

Methods: A sample of 51 children aged 5 to 10 years, diagnosed with OSA through PSG and referred for AT, was selected in a hospital based mouth-breathing specialized center. Children were divided in 2 groups: the AT group with 25 individuals, without maxillary hypoplasia, and the RME group composed of 26 children with maxillary constriction and posterior crossbite, with indication for RME before the AT surgery. Children underwent an initial evaluation at the time of selection (T0) and six months after the intervention: AT or RME (T1).

Conditions

  • Obstructive Sleep Apnea (OSA)
  • Rapid Maxillary Expansion
  • Polysomnography

Interventions

PROCEDURE

Adenotonsillectomy

the adenotonsillectomy group children, indicated for immediate adenotonsillectomy

PROCEDURE

Rapid maxillary expansion

expansion group children with a narrow palate and posterior crossbite, with indication for rapid maxillary expansion

Sponsors & Collaborators

  • Federal University of Minas Gerais

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-15
Primary Completion
2024-03-02
Completion
2025-04-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07069543 on ClinicalTrials.gov