Screening for Obstructive Sleep Apnea Syndrome in Children

Obstructive Sleep Apnea Clinical Trial

Official title:

Screening for Obstructive Sleep Apnea Syndrome in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05896176
• Other study ID #: P2022/377 / CCB B4062022000198
• Status: Recruiting
• Start date: December 9, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: May 2023
• Source: Université Libre de Bruxelles
• Contact: Astrid Vanden Abbeele
• Phone: 02/5556361
• Email: astrid.vanden.abbeele[@]ulb.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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? "

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 n°1) 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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 1, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

Inclusion Criteria:

• 2-8 years

Exclusion Criteria:

• Patients who do not speak French

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• a clinical examination and anamnesis
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.

Locations

Country	Name	City	State
Belgium	Tania Vanhée	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Université Libre de Bruxelles

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSQ + or -	Patient positive or negative on Pediatric Sleep Questionnaire (PSQ)	The data collection is carried out during the consultation
Primary	History/clinical examination + or -	Patient positive or negative at History/clinical examination	The data collection is carried out during the consultation