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

F

Federal University of Minas Gerais

Status

Completed

Conditions

Obstructive Sleep Apnea (OSA)
Polysomnography
Rapid Maxillary Expansion

Treatments

Procedure: Rapid maxillary expansion
Procedure: Adenotonsillectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT07069543
COEP/UFMG number 51038721.7.00

Details and patient eligibility

About

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).

Full 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%.

Enrollment

51 patients

Sex

All

Ages

5 to 10 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

51 participants in 2 patient groups

Adenotonsillectomy group
Experimental group
Description:
adenotonsillectomy surgical group
Treatment:
Procedure: Adenotonsillectomy
Rapid maxillary expansion group
Experimental group
Description:
rapid maxillary expansion group
Treatment:
Procedure: Rapid maxillary expansion

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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