Obstructive Sleep ApneaASCOTNCT07086612
Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Transverse Orthodontic Deficiency in Children
A study testing over nigtht ventilatory polysomnograph test in people with Obstructive Sleep Apnea and Transverse Maxillary Deficiency, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
OSAHS (Obstructive Sleep Apnea Hypopnea Syndrome) in children is a frequent respiratory disorder, whose prevalence is estimated at between 1.2 and 5.7%, and which, if left untreated, can cause severe medical complications. This prevalence tends to be underestimated. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Obstructive Sleep Apnea, Transverse Maxillary Deficiency
- What is being tested?
- over nigtht ventilatory polysomnograph test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2025to 30 Sep 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient aged between 6 and 16 years
- Patients with a transverse orthodontic deficiency (group "CAS")
- Patients with another type of orthodontic deficiency (group "CONTROL") such as tooth rotation, crowding, mild Angle Class II or Class III dental occlusion
- Patient who has given free, informed oral consent
- Patient whose legal representatives have given their free written consent
- Patient affiliated with a health insurance scheme
Who cannot join
- Patients refusing to participate in the study
- Patients whose legal representatives refuse to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service d'orthopédie dento-cranio-maxillo faciale
Rouen, 7600
Perrine KRUK, MD, +3344127963, kruk.perrine@live.fr
About this study
OSAHS (Obstructive Sleep Apnea Hypopnea Syndrome) in children is a frequent respiratory disorder, whose prevalence is estimated at between 1.2 and 5.7%, and which, if left untreated, can cause severe medical complications. This prevalence tends to be underestimated. Diagnosis is made following a clinical examination noting the presence of characteristic clinical and polysomnographic criteria. Multidisciplinary management has been widely described in the literature, and various therapeutic options have been indicated. Rapid maxillary expansion has proved highly effective in the treatment of this condition. This syndrome is a real public health problem and must be diagnosed as early as possible. Through our research, we would like to study whether there is a causal link between an orthodontic problem of the transverse direction and the presence of SAHOS in children. In other words, we would like to assess whether children who clinically present an orthodontic deficiency of their transverse dimension are more likely to develop SAHOS than children without this deficit. If this proves to be true, then a new clinical sign could enable certain healthcare professionals to detect this syndrome early, and be able to refer patients to physicians as soon as possible.
- Being tested
- over nigtht ventilatory polysomnograph test
- 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.
over nigtht ventilatory polysomnograph testDiagnostic test
Every patient will have an overnight polysomnography test.
| Study group | Role | What they receive |
|---|---|---|
| transverse deficiency maxilla | Experimental | patient with transverse deficiency maxilla Receives: Diagnostic Test: over nigtht ventilatory polysomnograph test |
| other type of maxilla deficiency | Other | patient with other type maxilla deficiency Receives: Diagnostic Test: over nigtht ventilatory polysomnograph test |
What is being measured
The primary outcome is the main question the study is designed to answer.
study whether children with a transverse orthodontic deficiency have a higher risk of developing Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) compared to those without this deficiency,
compare the proportion of children with an Apnea-Hypopnea Index (AHI) >1, , based on the presence or absence of a transverse deficiency." AHI is evaluated with the polysomnography exam
Measured: 1 months after enrollement
Secondary outcomes (4)
study whether all children with a transverse orthodontic deficiency systematically have Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
distribution of Apnea-Hypopnea Index (AHI) values among these children
Measured: one month after enrollement
Investigate a link between the severity of this transverse deficiency and the severity of OSAHS.
Distribution of AHI values among children based on the extent of the transverse deficiency. Three groups will be formed for the transverse deficiency : one for pure endognathies, one for endoalveolies, and one for crossbite occlusions.".
AHI is evaluated with the polysomnography exam.
Measured: 1month after enrollement
impact of hteSeverity of transferse deficiency on the snoring events frequency.
Average number of snoring events per hour based on the severity of the transverse deficiency. Three groups for the transverse defficiency will be formed: one for pure endognathies, one for endoalveolies, and one for crossbite occlusions.
Number of snoring event will be mesured by the polysomnography exam.
Measured: 1months after enrollement
diagnostic value of the sleep disorder screening scale for children aged 4 to 16 years
comparison of the sleep disorder screening scale results with the results of the polysomnography exam.
Measured: 1month after enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start6 Nov 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086612
- Sponsor's protocol ID
- 761-ASCOT
- Other IDs
- 2025-A00478-41
- Acronym
- ASCOT
- Status last verified
- Mar 2026
- First submitted
- 18 Jul 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Transverse Orthodontic Deficiency in Children
- ClinicalTrials.gov ID
- NCT07086612
- Acronym / sponsor ID
- ASCOT / 761-ASCOT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 25 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.
OSAHS (Obstructive Sleep Apnea Hypopnea Syndrome) in children is a frequent respiratory disorder, whose prevalence is estimated at between 1.2 and 5.7%, and which, if left untreated, can cause severe medical complications. This prevalence tends to be underestimated. Diagnosis is made following a clinical examination noting the presence of characteristic clinical and polysomnographic criteria. Multidisciplinary management has been widely described in the literature, and various therapeutic options have been indicated. Rapid maxillary expansion has proved highly effective in the treatment of this condition. This syndrome is a real public health problem and must be diagnosed as early as possible. Through our research, we would like to study whether there is a causal link between an orthodontic problem of the transverse direction and the presence of SAHOS in children. In other words, we would like to assess whether children who clinically present an orthodontic deficiency of their transverse dimension are more likely to develop SAHOS than children without this deficit. If this proves to be true, then a new clinical sign could enable certain healthcare professionals to detect this syndrome early, and be able to refer patients to physicians as soon as possible.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transverse deficiency maxilla | Experimental | Diagnostic Test: over nigtht ventilatory polysomnograph testpatient with transverse deficiency maxilla |
| other type of maxilla deficiency | Other | Diagnostic Test: over nigtht ventilatory polysomnograph testpatient with other type maxilla deficiency |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patient aged between 6 and 16 years
- Patients with a transverse orthodontic deficiency (group "CAS")
- Patients with another type of orthodontic deficiency (group "CONTROL") such as tooth rotation, crowding, mild Angle Class II or Class III dental occlusion
- Patient who has given free, informed oral consent
- Patient whose legal representatives have given their free written consent
Key exclusion criteria (2 listed)
- Patients refusing to participate in the study
- Patients whose legal representatives refuse to participate in the study
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 |
|---|---|---|
| over nigtht ventilatory polysomnograph testEvery patient will have an overnight polysomnography test. | Diagnostic test | other type of maxilla deficiency, transverse deficiency maxilla |
Primary outcome
study whether children with a transverse orthodontic deficiency have a higher risk of developing Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) compared to those without this deficiency,
Time frame: 1 months after enrollement
compare the proportion of children with an Apnea-Hypopnea Index (AHI) >1, , based on the presence or absence of a transverse deficiency." AHI is evaluated with the polysomnography exam
4 secondary outcomes
study whether all children with a transverse orthodontic deficiency systematically have Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
Time frame: one month after enrollement
Investigate a link between the severity of this transverse deficiency and the severity of OSAHS.
Time frame: 1month after enrollement
impact of hteSeverity of transferse deficiency on the snoring events frequency.
Time frame: 1months after enrollement
diagnostic value of the sleep disorder screening scale for children aged 4 to 16 years
Time frame: 1month after enrollement
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 30 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing over nigtht ventilatory polysomnograph test in people with Obstructive Sleep Apnea and Transverse Maxillary Deficiency, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. 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 France. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
study whether children with a transverse orthodontic deficiency have a higher risk of developing Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) compared to those without this deficiency, (time frame: 1 months after enrollement). 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 30 Mar 2026.