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.
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
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.
- Conditions
- Apnea, Obstructive Sleep
- 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 group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients 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.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
- First posted6 Jun 2025
- Study start1 Jul 2025
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea, Obstructive SleepStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD, Principal investigator, Associate Professor
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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Apnoea Hypopnoea Index (AHI) and Malocclusions in Growing Patients With Maxillary Constriction: a Prospective Clinical Study.
- ClinicalTrials.gov ID
- NCT07009535
- Acronym / sponsor ID
- 2025-AHIO2AIRWAYS
- Conditions
- Apnea, Obstructive Sleep
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 6 Jun 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.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Diagnostic Test: PolysomnographyPatients between 6 and 12 years with maxillary constriction (intermolar distance < 31 mm) requiring rapid palatal expander therapy and with AHI > 1 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- mixed dentition
- transversal skeletal constriction of the upper jaw, with or without cross-bite
- Tonsillar grade I-III according to Mallampati classification
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| PolysomnographyAssessment of AHI index and pO2 in pediatric patients | Diagnostic test | Study group |
Primary outcome
Apnea-Hypopnea Index (AHI)
Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)
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.
17 secondary outcomes
SNA Angle
Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)
SNB Angle
Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)
ANB Angle
Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)
Cranio-mandibular Angle (SN^GoGn)
Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)
Intermaxillary Angle (ANS-PNS^GoGn)
Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)
Ad1-SNP
Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)
Ad2-SNP
Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)
MPP-SPAS
Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)
U1-U2
Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)
T1-T2
Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)
Thickness (MPP-MPA)
Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)
Length (U-SNP)
Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)
MPH
Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)
Molar Class
Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)
Overjet
Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)
Overbite
Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)
Oxygen Saturation (Nadir SpO2)
Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the Principal Investigator.
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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.
Andrea Scribante, DDS, PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
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.