NCT07069543

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Federal University of Minas Gerais · Academic / Other
• Sex: All
• Age: 5 Years – 10 Years
• Healthy volunteers: Not accepted

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).

Detailed description

PSG was performed to measure the apnea/hypopnea index (AHI), mean and minimum oxygen saturation (SpO2), desaturation index and desaturation time below 90%. AAR was used to measure nasal inspiratory flow (NIF), % NIF and nasal resistance. To compare the differences between the groups at T0, T1 and T1-T0, t-tests and Mann-Whitney tests were used. To compare the changes resulting from ERM and AT, paired t-tests and the Wilcoxon test were used, for a statistical significance level of 5%.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-02-15
• Primary completion: 2024-03-02
• Completion: 2025-04-30
• First posted: 2025-07-16
• Last updated: 2025-07-16

Locations

1 site across 1 country: Brazil