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Clinical Trials/NCT05896176
NCT05896176RecruitingNot Applicable

Screening for Obstructive Sleep Apnea Syndrome in Children

Université Libre de Bruxelles1 site in 1 country150 target enrollmentStarted: December 9, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
150
Locations
1
Primary Endpoint
History/clinical examination + or -

Study Overview

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 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

  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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
2 Years to 8 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 2-8 years

Exclusion Criteria

  • Patients who do not speak French

Outcomes

Primary Outcomes

History/clinical examination + or -

Time Frame: The data collection is carried out during the consultation

Patient positive or negative at History/clinical examination

PSQ + or -

Time Frame: The data collection is carried out during the consultation

Patient positive or negative on Pediatric Sleep Questionnaire (PSQ)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tania Vanhée

Dr.

Université Libre de Bruxelles

Study Sites (1)

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