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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07069543
Enrollment
51
Registered
2025-07-16
Start date
2021-02-15
Completion date
2025-04-30
Last updated
2025-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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%.

Interventions

PROCEDUREAdenotonsillectomy

the adenotonsillectomy group children, indicated for immediate adenotonsillectomy

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

Sponsors

Federal University of Minas Gerais
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
polysomnography measuresChildren underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).PSG was performed to measure the apnea/hypopnea index (AHI)

Secondary

MeasureTime frameDescription
anterior active rhinomanometry measuresChildren underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).AAR was used to measure the nasal inspiratory flow (NIF)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026