Obstructive Sleep Apnea (OSA)NCT07069543
Changes in Polysomnography and Rhinomanometry Parameters After Rapid Maxillary Expansion or Adenotonsilectomy in Children With Obstructive Sleep Apnea
A study testing Adenotonsillectomy and Rapid maxillary expansion in people with Obstructive Sleep Apnea (OSA) and Rapid Maxillary Expansion, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA), Rapid Maxillary Expansion, Polysomnography
- What is being tested?
- Adenotonsillectomy and Rapid maxillary expansion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Feb 2021to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, 30.130-100
About this study
Official title: Changes in Polysomnography and Rhinomanometry Parameters After Rapid Maxillary Expansion or Adenotonsilectomy in Children With 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).
Read the 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%.
- Being tested
- Adenotonsillectomy, Rapid maxillary expansion
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenotonsillectomyProcedure or surgery
the adenotonsillectomy group children, indicated for immediate adenotonsillectomy
Rapid maxillary expansionProcedure or surgery
expansion group children with a narrow palate and posterior crossbite, with indication for rapid maxillary expansion
| Study group | Role | What they receive |
|---|---|---|
| Adenotonsillectomy group | Experimental | adenotonsillectomy surgical group Receives: Procedure: Adenotonsillectomy |
| Rapid maxillary expansion group | Experimental | rapid maxillary expansion group Receives: Procedure: Rapid maxillary expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
polysomnography measures
PSG was performed to measure the apnea/hypopnea index (AHI)
Measured: Children underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).
polysomnography measures
PSG was performed to measure the mean and minimum oxygen saturation (SpO2)
Measured: Children underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).
polysomnography measures
PSG was performed to measure the desaturation index
Measured: Children underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).
polysomnography measures
PSG was performed to measure the desaturation time below 90%.
Measured: Children underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).
Secondary outcomes (3)
anterior active rhinomanometry measures
AAR was used to measure the nasal inspiratory flow (NIF)
Measured: Children underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).
anterior active rhinomanometry measures
AAR was used to measure the nasal inspiratory flow percent (NIF)
Measured: Children underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).
anterior active rhinomanometry measures
AAR was used to measure the nasal resistance.
Measured: Children underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start15 Feb 2021
- Primary completion2 Mar 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Maciel Tinano, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069543
- Sponsor's protocol ID
- COEP/UFMG number 51038721.7.00
- Status last verified
- Jul 2025
- First submitted
- 2 Jun 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Polysomnography and Rhinomanometry Parameters After Rapid Maxillary Expansion or Adenotonsilectomy in Children With Sleep Apnea
- ClinicalTrials.gov ID
- NCT07069543
- Acronym / sponsor ID
- COEP/UFMG number 51038721.7.00
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 2 Mar 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Adenotonsillectomy group | Experimental | Procedure: Adenotonsillectomyadenotonsillectomy surgical group |
| Rapid maxillary expansion group | Experimental | Procedure: Rapid maxillary expansionrapid maxillary expansion group |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adenotonsillectomythe adenotonsillectomy group children, indicated for immediate adenotonsillectomy | Procedure or surgery | Adenotonsillectomy group |
| Rapid maxillary expansionexpansion group children with a narrow palate and posterior crossbite, with indication for rapid maxillary expansion | Procedure or surgery | Rapid maxillary expansion group |
Primary outcome
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)
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)
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
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%.
3 secondary outcomes
anterior active rhinomanometry measures
Time frame: Children underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).
anterior active rhinomanometry measures
Time frame: Children underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).
anterior active rhinomanometry measures
Time frame: Children underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adenotonsillectomy and Rapid maxillary expansion in people with Obstructive Sleep Apnea (OSA) and Rapid Maxillary Expansion, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
polysomnography measures (time frame: Children underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.