CompletedNot Applicable

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

Brazil51 participantsStarted 2021-02-15

Plain-language 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).

Who can participate

Age range

5 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

polysomnography measures

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

polysomnography measures

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

polysomnography measures

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

polysomnography measures

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

Trial details

NCT IDNCT07069543

SponsorFederal University of Minas Gerais

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-02

View on ClinicalTrials.gov More Obstructive Sleep Apnea (OSA) trials

Plain-language summary

Who can participate

Age range

5 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

polysomnography measures

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

polysomnography measures

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

polysomnography measures

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

polysomnography measures

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