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Apnea, Obstructive SleepNCT07009535

Associations Apnoea Hypopnoea Index (AHI) and Malocclusions in Growing Patients With Maxillary Constriction

A study testing Polysomnography in people with Apnea, Obstructive Sleep, run by University of Pavia at 1 site in Italy.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The aim of this prospective clinical study is to evaluate the association between the Apnoea Hypopnoea Index (AHI) and the type of malocclusion in pediatric patients with maxillary constriction. Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Apnea, Obstructive Sleep
What is being tested?
Polysomnography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
1 Jul 2025to Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • mixed dentition
  • transversal skeletal constriction of the upper jaw, with or without cross-bite
  • Tonsillar grade I-III according to Mallampati classification

Who cannot join

  • Previous orthodontic treatment
  • Previous adenoidectomy, tonsillectomy, or any surgical interventions of the upper airways;
  • Tonsillar grade IV
  • Presence of remote or familial pathologies;
  • Presence of syndromes or forms of disability

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site
  • Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

    Pavia, Lombardy, 27100

Other trials in Italy

About this study

Official title: Associations Apnoea Hypopnoea Index (AHI) and Malocclusions in Growing Patients With Maxillary Constriction: a Prospective Clinical Study.

The aim of this prospective clinical study is to evaluate the association between the Apnoea Hypopnoea Index (AHI) and the type of malocclusion in pediatric patients with maxillary constriction. Malocclusion will be assessed through clinical examination and cephalometric analysis, which will also include an evaluation of the airway. Additionally, the study aims to assess potential changes in OSAS symptoms in patients undergoing orthopedic-orthodontic treatment with maxillary expansion. The AHI assessment will be conducted using nocturnal cardiorespiratory monitoring.

Read the detailed description

This observational study aims to evaluate possible associations between data obtained from cardiorespiratory monitoring, clinical examination, and cephalometric analysis in patients with maxillary constriction. First, patients aged 6 to 12 years who present to the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic, and Pediatric Sciences of the University of Pavia will undergo a clinical examination to assess the presence of malocclusions. If malocclusions are identified, the necessary records for the patient's diagnostic-therapeutic assessment will be collected. During the initial visit, parents will also be asked to complete the PSQ-SRBD questionnaire (1) (Appendix A), which serves as a screening test for OSAS. Subsequently, the transpalatal width will be measured on plaster or digital models by evaluating the intermolar distance. According to McNamara, this value in mixed dentition without crowding or spacing ranges between 34 and 36 mm (2), while it is less than 31 mm in cases of crowding, indicating the need for orthopedic or surgical expansion (3). In this study, a cut-off value of 31 mm was used to select the sample with maxillary constriction. If such a malocclusion is present, the operators will verify whether the patient meets the study's inclusion criteria. Cephalometric analysis will be performed on lateral cranial radiographs, focusing on craniofacial characteristics and upper airway measurements, as detailed later in the protocol. The selected children will then be referred to the Sleep Medicine Center at the Mondino Foundation for cardiorespiratory monitoring (AHI). Data from the polygraphic examination, cephalometric analysis, and clinical evaluation will be compared using statistical analysis. If the patient is diagnosed with OSAS (AHI >1) and requires palatal expansion, cardiorespiratory monitoring, clinical evaluation, and cephalometric analysis will be repeated after treatment with an expander and compared with the initial data.

Being tested
Polysomnography
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.

  • PolysomnographyDiagnostic test

    Assessment of AHI index and pO2 in pediatric patients

Study groups in NCT07009535
Study groupRoleWhat they receive
Study groupExperimentalPatients between 6 and 12 years with maxillary constriction (intermolar distance < 31 mm) requiring rapid palatal expander therapy and with AHI > 1
Receives: Diagnostic Test: Polysomnography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Apnea-Hypopnea Index (AHI)

    The number of apneas and/or hypopneas per hour of recording. It is considered mild OSAS if AHI is between 1 and 5; moderate OSAS if AHI is between 5 and 10; severe OSAS if AHI is greater than 10.

    Measured: Baseline (T0) and after 1 year of treatment with RPE (T1)

Secondary outcomes (17)
  1. SNA Angle

    Determined by the intersection of the sellar plane (SN) with the N-point A line; it indicates the anteroposterior position of the maxilla relative to the cranial base. Mean value: 82° ± 2°.

    Measured: Baseline (T0) and after 1 year of treatment with RPE (T1)

  2. SNB Angle

    Determined by the intersection of the sellar plane (SN) with the N-point B line; it indicates the anteroposterior position of the mandible relative to the cranial base. Mean value: 80° ± 2°.

    Measured: Baseline (T0) and after 1 year of treatment with RPE (T1)

  3. ANB Angle

    Determined by the intersection of the N-point A line with the N-point B line; it indicates the anteroposterior relationship between the maxilla and mandible. The discrepancy identified by this angle defines the skeletal class. Mean value: 2° ± 2°.

    Measured: Baseline (T0) and after 1 year of treatment with RPE (T1)

  4. Cranio-mandibular Angle (SN^GoGn)

    Determined by the intersection of the sellar plane (SN) with the mandibular plane (GoGn); it indicates the type of vertical facial growth of the subject. Mean value: 32° ± 5°.

    Measured: Baseline (T0) and after 1 year of treatment with RPE (T1)

  5. Intermaxillary Angle (ANS-PNS^GoGn)

    Determined by the intersection of the bipupillary plane (ANS-PNS) with the mandibular plane (GoGn); it indicates the degree of divergence of the mandible relative to the cranial base. Mean value: 20° ± 5°.

    Measured: Baseline (T0) and after 1 year of treatment with RPE (T1)

  6. Ad1-SNP

    Linear distance between SNP and the closest point on the posterior wall of the pharynx along the line connecting SNP-Ba.

    Measured: Baseline (T0) and after 1 year of treatment with RPE (T1)

  7. Ad2-SNP

    Linear distance between SNP and the closest point on the posterior wall of the pharynx measured through the perpendicular line to the connecting S-Ba from the SNP point.

    Measured: Baseline (T0) and after 1 year of treatment with RPE (T1)

  8. MPP-SPAS

    Superior pharyngeal space. Connects the point MPP (midpoint of the pharyngeal side of the velum placed on a line perpendicular to the line connecting SNP-U1) and the point SPAS (point on the posterior wall of the pharynx determined by a perpendicular line to the posterior pharyngeal wall passing through MPP).

    Measured: Baseline (T0) and after 1 year of treatment with RPE (T1)

  9. U1-U2

    Middle pharyngeal space: connects U1 (tip of the soft palate) and U2 (point on the posterior wall of the pharynx determined by a perpendicular line to the posterior pharyngeal wall passing through U1).

    Measured: Baseline (T0) and after 1 year of treatment with RPE (T1)

  10. T1-T2

    Inferior pharyngeal space: distance between point T1 (intersection between the tongue base and the lower margin of the mandible) and point T2 (projection of point T1 on the posterior wall of the pharynx along the parallel to the line Go-Ba).

    Measured: Baseline (T0) and after 1 year of treatment with RPE (T1)

  11. Thickness (MPP-MPA)

    Connects the points MPP (midpoint of the pharyngeal side of the velum, placed on a line perpendicular to the line connecting SNP with U1) and MPA (point on the oral side of the velum placed on a line perpendicular to the line connecting SNP with U1).

    Measured: Baseline (T0) and after 1 year of treatment with RPE (T1)

  12. Length (U-SNP)

    Distance between the tip of the soft palate (U1) and the posterior nasal spine (SNP).

    Measured: Baseline (T0) and after 1 year of treatment with RPE (T1)

  13. MPH

    Distance between point H1 (most cranial point of the hyoid bone) and point H2 (projection of point H1 on the perpendicular to the lower margin of the mandible - GoGn).

    Measured: Baseline (T0) and after 1 year of treatment with RPE (T1)

  14. Molar Class

    • Class I molar: The mesiobuccal cusp of the upper first molar contacts the vestibular groove of the lower first molar.
    • Class II molar: The mesiobuccal cusp of the upper first molar occludes mesially to the vestibular groove of the lower first molar.
    • Class III molar: The mesiobuccal cusp of the upper first molar occludes distally to the vestibular groove of the lower first molar.

    Measured: Baseline (T0) and after 1 year of treatment with RPE (T1)

  15. Overjet

    The distance, in the sagittal plane, between the upper and lower incisal edges. Mean value: 2 ± 2 mm. If > 2 mm, it is considered "increased"; if < 2 mm, it is considered "reduced".

    Measured: Baseline (T0) and after 1 year of treatment with RPE (T1)

  16. Overbite

    The distance, in the vertical plane, between the upper and lower incisal edges. Mean value: 2 ± 2 mm. If > 2 mm, it is considered "increased"; if < 2 mm, it is considered "reduced".

    Measured: Baseline (T0) and after 1 year of treatment with RPE (T1)

  17. Oxygen Saturation (Nadir SpO2)

    The minimum percentage of oxygen-saturated hemoglobin at the time of measurement. SpO2 values are as follows: between 86% and 91% in mild OSAS, between 76% and 85% in moderate OSAS, and less than 75% in severe OSAS.

    Measured: Baseline (T0) and after 1 year of treatment with RPE (T1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2025
  2. Study start1 Jul 2025
  3. Primary completionJul 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07009535
Sponsor's protocol ID
2025-AHIO2AIRWAYS
Status last verified
Nov 2025
First submitted
29 May 2025
Last updated
18 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be available upon motivated request to the Principal Investigator.

Questions about this trial

What is this clinical trial studying?

A study testing Polysomnography in people with Apnea, Obstructive Sleep, run by University of Pavia at 1 site in Italy.

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 5 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: enrolling by invitation, as of the sponsor's last update on 18 Nov 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 Italy. 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?

This study is still under way. Results are not available in the source record yet.

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?

Apnea-Hypopnea Index (AHI) (time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)). 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 18 Nov 2025.

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