Obstructive Sleep ApneaNCT05896176
Screening for Obstructive Sleep Apnea Syndrome in Children
An observational study of Obstructive Sleep Apnea, run by Université Libre de Bruxelles at 1 site in Belgium.
Trial summary
To be able to diagnose obstructive sleep apnea syndrome (OSAS) in a patient, polysomnography (PSG) remains the gold standard. However, this is expensive, involves a considerable workload and is quite complex. Read more about this study
- Who is it for?
- Ages 2 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- a clinical examination and anamnesis
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Dec 2022to 1 Jul 2023
- Phase
- Observational
- 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 2 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients between 2 and 8 years old presenting to the pediatric dentistry consultation at Erasmus Hospital,EMC site, speaking French and agreeing to participate in the study
Who may be able to join
- 2-8 years
Who cannot join
- Patients who do not speak French
Trial locations and contacts
1 site in 1 country.
Tania Vanhée contact
Belgium1 site, 1 recruiting
- Recruiting
Tania Vanhée
Brussels, 1000
Tania Vanhée, DDS, +32478613102, tania.vanhee@ulb.be
About this study
To be able to diagnose obstructive sleep apnea syndrome (OSAS) in a patient, polysomnography (PSG) remains the gold standard. However, this is expensive, involves a considerable workload and is quite complex. Additionally, the wait time from when the patient was referred for PSG to when it is done can take up to 5-6 months. Simpler screening tools have therefore been developed, such as questionnaires. The questionnaires are subjective tools completed by the parents based on the observation of the child's sleep, behavioral problems, etc. These questionnaires have shown usefulness in sorting out patients to be referred to a sleep specialist, an Oto-Rhino-Laryngologist (ENT) or an orthodontist before performing a PSG in view of the difficulty of access to it. The Pediatric Sleep Questionnaire (PSQ) is a tool that was developed by Chervin and his colleagues to screen children with OSAS. This questionnaire is a reliable and scientifically validated tool. In addition, the PSQ is the most accurate questionnaire from a screening point of view. However, the American Academy of Pediatric Dentistry (AAPD) considers that the questionnaires, among others, the PSQ, are not sensitive enough to detect OSAS in a child. They offer an anamnesis as well as a clinical examination to be carried out in addition to the few questions taken from the PSQ that they consider useful for screening patients at risk. The investigators can therefore ask themselves the following question: "Is the PSQ sufficient on its own or do the investigators obtain better results when the investigators carry out a complete anamnesis as well as a clinical examination? "
Read the detailed description
- Bibliographic research methodology In order to have a relevant bibliographic base, the investigators selected articles with a high level of evidence and the most recent. For this, the investigators carried out their research on the following sites and databases: Pubmed, Sciences Direct, Google Scholar, ResearchGate, Tripdatabase and Cible +. Several research equations have allowed us to have satisfactory results. When the results were too broad, the investigators restricted their search to meta-analyses and systematic reviews. The following keywords were used: "Pediatric Sleep Questionnaire", "dentistry", "sleep apnea", "child", "surveys and questionnaires", "sleep apnea, obstructive", "diagnosis accuracy" The most relevant articles that allowed them to establish the research question were found on Pubmed and Sciences Direct. (appendix n°1) Concerning Google Scholar, Tripdatabase and Cible +, the articles found were either already selected articles or were not sufficiently targeted on the subject.
- Agreement of the ethics committee The study is a prospective observational study carried out within the Erasmus HUB site and therefore required the approval of its ethics committee. The required documents were introduced on the DycoFlow platform on August 31, 2022. They gave their agreement to submit my request to the ethics committee on September 20, 2022. The Erasmus ethics committee gave its agreement on September 9, 2022. December 2022.
- Study methodology
- Inclusion and exclusion criteria
The investigators decided to limit the study to children aged 2 to 8 years. Indeed, interceptive orthodontic treatment must be performed before the 9th birthday to be reimbursed if necessary. Moreover, if ENT surgery is necessary (tonsillectomy for example), it is advantageous to perform it as soon as possible. quickly as possible to avoid the long-term consequences of mouth breathing. The investigators also excluded patients whose parents did not speak French.
- Objective of the study
The study will therefore consist in comparing the results using on the one hand the PSQ only, on the other hand the clinical examination and the anamnesis as well as the three together and see if the results are comparable.
II. Realization of questionnaires
- Pediatric Sleep Questionnaire translated into French (validated translation)
- Anamnesis
- Clinical examination
Concerning the anamnesis and the clinical examination, the investigators based themselves on the recommendations given by the AAPD. Indeed, some studies have shown that the questionnaire gives better results when combined with a clinical examination.
III. Data collection
The study took place within the Erasmus site HUB, at the Erasmus Medical Center (EMC) during pediatric dentistry consultations.
The parents of the patients were approached from the beginning of the consultation in order to integrate the study. Oral explanations concerning the purpose and conduct of the study were given in addition to informed consent. In addition, the children also received appropriate informed consent explaining the course of the study if the age and maturity of the child permitted it.
The PSQ and the anamnesis are carried out during the consultation with the parent. Once the consultation is over, the clinical examination is carried out with the consent of the child.
If the PSQ turned out to be positive, i.e. the child obtained a score equal to or greater than 7 positive responses out of 22, a liaison letter was sent to refer the child to an ENT specialist. The investigators also asked for an e-mail report of the consultation. This was also the case for the anamnesis and the clinical examination.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- a clinical examination and anamnesis
- Keywords
- child
- 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.
a clinical examination and anamnesisDiagnostic test
The investigators compare the results of the PSQ alone with the elements provided by the clinical examination regarding the referral of patients to the Otolaryngologist (ENT) consultation.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Sleep Questionnaire (PSQ) + | Patient who obtained a score of 7 or more on the PSQ Receives: Diagnostic Test: a clinical examination and anamnesis | |
| Pediatric Sleep Questionnaire (PSQ) - | Patient who obtained a PSQ score less than 7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSQ + or -
Patient positive or negative on Pediatric Sleep Questionnaire (PSQ)
Measured: The data collection is carried out during the consultation
History/clinical examination + or -
Patient positive or negative at History/clinical examination
Measured: The data collection is carried out during the consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start9 Dec 2022
- Primary completion31 Mar 2023
- Study completion1 Jul 2023 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tania Vanhée, Université Libre de Bruxelles
- Investigators
- Fairouz Ben Abdelouahed, Principal investigator, Directrice du service de Dentisterie HUB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896176
- Sponsor's protocol ID
- P2022/377 / CCB B4062022000198
- Status last verified
- May 2023
- First submitted
- 10 Apr 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Obstructive Sleep Apnea Syndrome in Children
- ClinicalTrials.gov ID
- NCT05896176
- Acronym / sponsor ID
- P2022/377 / CCB B4062022000198
- Conditions
- Obstructive Sleep Apnea
- Keywords
- child
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 9 Jun 2023 (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.
To be able to diagnose obstructive sleep apnea syndrome (OSAS) in a patient, polysomnography (PSG) remains the gold standard. However, this is expensive, involves a considerable workload and is quite complex. Additionally, the wait time from when the patient was referred for PSG to when it is done can take up to 5-6 months. Simpler screening tools have therefore been developed, such as questionnaires. The questionnaires are subjective tools completed by the parents based on the observation of the child's sleep, behavioral problems, etc. These questionnaires have shown usefulness in sorting out patients to be referred to a sleep specialist, an Oto-Rhino-Laryngologist (ENT) or an orthodontist before performing a PSG in view of the difficulty of access to it. The Pediatric Sleep Questionnaire (PSQ) is a tool that was developed by Chervin and his colleagues to screen children with OSAS. This questionnaire is a reliable and scientifically validated tool. In addition, the PSQ is the most accurate questionnaire from a screening point of view. However, the American Academy of Pediatric Dentistry (AAPD) considers that the questionnaires, among others, the PSQ, are not sensitive enough to detect OSAS in a child. They offer an anamnesis as well as a clinical examination to be carried out in addition to the few questions taken from the PSQ that they consider useful for screening patients at risk. The investigators can therefore ask themselves the following question: "Is the PSQ sufficient on its own or do the investigators obtain better results when the investigators carry out a complete anamnesis as well as a clinical examination? "
Detailed description
- Bibliographic research methodology In order to have a relevant bibliographic base, the investigators selected articles with a high level of evidence and the most recent. For this, the investigators carried out their research on the following sites and databases: Pubmed, Sciences Direct, Google Scholar, ResearchGate, Tripdatabase and Cible +. Several research equations have allowed us to have satisfactory results. When the results were too broad, the investigators restricted their search to meta-analyses and systematic reviews. The following keywords were used: "Pediatric Sleep Questionnaire", "dentistry", "sleep apnea", "child", "surveys and questionnaires", "sleep apnea, obstructive", "diagnosis accuracy" The most relevant articles that allowed them to establish the research question were found on Pubmed and Sciences Direct. (appendix n°1) Concerning Google Scholar, Tripdatabase and Cible +, the articles found were either already selected articles or were not sufficiently targeted on the subject.
- Agreement of the ethics committee The study is a prospective observational study carried out within the Erasmus HUB site and therefore required the approval of its ethics committee. The required documents were introduced on the DycoFlow platform on August 31, 2022. They gave their agreement to submit my request to the ethics committee on September 20, 2022. The Erasmus ethics committee gave its agreement on September 9, 2022. December 2022.
- Study methodology
- Inclusion and exclusion criteria
The investigators decided to limit the study to children aged 2 to 8 years. Indeed, interceptive orthodontic treatment must be performed before the 9th birthday to be reimbursed if necessary. Moreover, if ENT surgery is necessary (tonsillectomy for example), it is advantageous to perform it as soon as possible. quickly as possible to avoid the long-term consequences of mouth breathing. The investigators also excluded patients whose parents did not speak French.
- Objective of the study
The study will therefore consist in comparing the results using on the one hand the PSQ only, on the other hand the clinical examination and the anamnesis as well as the three together and see if the results are comparable.
II. Realization of questionnaires
- Pediatric Sleep Questionnaire translated into French (validated translation)
- Anamnesis
- Clinical examination
Concerning the anamnesis and the clinical examination, the investigators based themselves on the recommendations given by the AAPD. Indeed, some studies have shown that the questionnaire gives better results when combined with a clinical examination.
III. Data collection
The study took place within the Erasmus site HUB, at the Erasmus Medical Center (EMC) during pediatric dentistry consultations.
The parents of the patients were approached from the beginning of the consultation in order to integrate the study. Oral explanations concerning the purpose and conduct of the study were given in addition to informed consent. In addition, the children also received appropriate informed consent explaining the course of the study if the age and maturity of the child permitted it.
The PSQ and the anamnesis are carried out during the consultation with the parent. Once the consultation is over, the clinical examination is carried out with the consent of the child.
If the PSQ turned out to be positive, i.e. the child obtained a score equal to or greater than 7 positive responses out of 22, a liaison letter was sent to refer the child to an ENT specialist. The investigators also asked for an e-mail report of the consultation. This was also the case for the anamnesis and the clinical examination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric Sleep Questionnaire (PSQ) + | – | Diagnostic Test: a clinical examination and anamnesisPatient who obtained a score of 7 or more on the PSQ |
| Pediatric Sleep Questionnaire (PSQ) - | – | –Patient who obtained a PSQ score less than 7 |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients between 2 and 8 years old presenting to the pediatric dentistry consultation at Erasmus Hospital,EMC site, speaking French and agreeing to participate in the study
Key inclusion criteria (1 listed)
- 2-8 years
Key exclusion criteria (1 listed)
- Patients who do not speak French
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 |
|---|---|---|
| a clinical examination and anamnesisThe investigators compare the results of the PSQ alone with the elements provided by the clinical examination regarding the referral of patients to the Otolaryngologist (ENT) consultation. | Diagnostic test | Pediatric Sleep Questionnaire (PSQ) + |
Primary outcome
PSQ + or -
Time frame: The data collection is carried out during the consultation
Patient positive or negative on Pediatric Sleep Questionnaire (PSQ)
History/clinical examination + or -
Time frame: The data collection is carried out during the consultation
Patient positive or negative at History/clinical examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- 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. This study is not recruiting at the moment.
Tania Vanhée contact
Fairouz Ben Abdelouahed principal investigator
Directrice du service de Dentisterie HUB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Université Libre de Bruxelles at 1 site in Belgium.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Jun 2023. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Astrid Vanden Abbeele (02/5556361, astrid.vanden.abbeele@ulb.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSQ + or - (time frame: The data collection is carried out during the consultation). The study lists 2 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 9 Jun 2023.