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

NCT ID: NCT07069543

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-15
• Study Completion Date: 2025-04-30

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).

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Adenotonsillectomy group

adenotonsillectomy surgical group

Group Type: EXPERIMENTAL

Adenotonsillectomy

Intervention Type: PROCEDURE

the adenotonsillectomy group children, indicated for immediate adenotonsillectomy

Rapid maxillary expansion group

rapid maxillary expansion group

Group Type: EXPERIMENTAL

Rapid maxillary expansion

Intervention Type: PROCEDURE

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

Interventions

Adenotonsillectomy

the adenotonsillectomy group children, indicated for immediate adenotonsillectomy

Intervention Type: PROCEDURE

Rapid maxillary expansion

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Mariana Maciel Tinano

Associate Professor, Outpatient clinic for the Mouth-breathers,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

COEP/UFMG number 51038721.7.00

Identifier Type: -

Identifier Source: org_study_id