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NCT Number: NCT07069543

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

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).

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Key information

Conditions

Obstructive Sleep Apnea (OSA) Apnea Dyssomnias Nervous System Diseases Polysomnography Rapid Maxillary Expansion Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30.130-100, Brazil

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adenotonsillectomy

Procedure

the adenotonsillectomy group children, indicated for immediate adenotonsillectomy

Rapid maxillary expansion

Procedure

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

Primary outcomes

  1. polysomnography measures

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

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

  2. polysomnography measures

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

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

  3. polysomnography measures

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

    PSG was performed to measure the desaturation index

  4. polysomnography measures

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

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

Secondary outcomes

  1. anterior active rhinomanometry measures

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

    AAR was used to measure the nasal inspiratory flow (NIF)

  2. anterior active rhinomanometry measures

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

    AAR was used to measure the nasal inspiratory flow percent (NIF)

  3. anterior active rhinomanometry measures

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

    AAR was used to measure the nasal resistance.

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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