Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05896176
Status:
RECRUITING
Last Update Posted:
2023-06-09
First Post:
2023-04-10
Brief Title:
Screening for Obstructive Sleep Apnea Syndrome in Children
Sponsor:
Université Libre de Bruxelles
Organization:
Université Libre de Bruxelles
Study Overview
Official Title:
Screening for Obstructive Sleep Apnea Syndrome in Children
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 childs 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:
1 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 n1 Concerning Google Scholar Tripdatabase and Cible the articles found were either already selected articles or were not sufficiently targeted on the subject
2 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
3 Study methodology
I 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
I 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 ie 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
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 n1 Concerning Google Scholar Tripdatabase and Cible the articles found were either already selected articles or were not sufficiently targeted on the subject
2 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
3 Study methodology
I 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
I 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None