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

NCT07069543 | Completed DMC

• 1 other identifier: COEP/UFMG number 51038721.7.00
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• polysomnography measures

  PSG was performed to measure the apnea/hypopnea index (AHI)

  Children underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).

• polysomnography measures

  PSG was performed to measure the mean and minimum oxygen saturation (SpO2)

  Children underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).

• polysomnography measures

  PSG was performed to measure the desaturation index

  Children underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).

• polysomnography measures

  PSG was performed to measure the desaturation time below 90%.

  Children underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).

Secondary Outcomes (3)

• anterior active rhinomanometry measures

  Children underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).

• anterior active rhinomanometry measures

  Children underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).

• anterior active rhinomanometry measures

  Children underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).

Study Arms (2)

Adenotonsillectomy group

EXPERIMENTAL

adenotonsillectomy surgical group

Procedure: Adenotonsillectomy

Rapid maxillary expansion group

EXPERIMENTAL

rapid maxillary expansion group

Procedure: Rapid maxillary expansion

Interventions

Adenotonsillectomy PROCEDURE

the adenotonsillectomy group children, indicated for immediate adenotonsillectomy

Adenotonsillectomy group

Rapid maxillary expansion PROCEDURE

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

Rapid maxillary expansion group

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of OSA confirmed by polysomnography
• between 5 and 10 years of age
• Indication for adenotonsillectomy (adenoids occupying more than 75% of the nasopharynx and/or tonsils classified as degree 3 or 4)

You may not qualify if:

• Children with systemic diseases
• craniofacial syndromes that interfered with functional and psychosocial development,
• children who did not complete the expansion
• parents did not sign the informed consent

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30.130-100, Brazil

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Outpatient clinic for the Mouth-breathers,

Model Details: 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).

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: July 16, 2025
• Study Start: February 15, 2021
• Primary Completion: March 2, 2024
• Study Completion: April 30, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: Statistical analyses of the study results will be shared through Excel spreadsheets

Locations

BR (1)