Screening for Obstructive Sleep Apnea Syndrome in Children

NCT05896176 | Unknown DMC

• 1 other identifier: P2022/377 / CCB B4062022000198
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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? "

Conditions

Obstructive Sleep Apnea

Keywords

child

Outcome Measures

Primary Outcomes (2)

• PSQ + or -

  Patient positive or negative on Pediatric Sleep Questionnaire (PSQ)

  The data collection is carried out during the consultation

• History/clinical examination + or -

  Patient positive or negative at History/clinical examination

  The data collection is carried out during the consultation

Study Arms (2)

Pediatric Sleep Questionnaire (PSQ) +

Patient who obtained a score of 7 or more on the PSQ

Diagnostic Test: a clinical examination and anamnesis

Pediatric Sleep Questionnaire (PSQ) -

Patient who obtained a PSQ score less than 7

Interventions

a clinical examination and anamnesis DIAGNOSTIC_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.

Pediatric Sleep Questionnaire (PSQ) +

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• \- 2-8 years

You may not qualify if:

• Patients who do not speak French

Sponsors & Collaborators

• Université Libre de Bruxelles: lead

Study Sites (1)

Tania Vanhée

Brussels, 1000, Belgium

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Immunologic Memory

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Adaptive Immunity; Immunity; Immune System Phenomena

Study Officials

• Fairouz Ben Abdelouahed

  Directrice du service de Dentisterie HUB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Astrid Vanden Abbeele

CONTACT

02/5556361; astrid.vanden.abbeele@ulb.be

Tania Vanhée

CONTACT

tania.vanhee@ulb.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: June 9, 2023
• Study Start: December 9, 2022
• Primary Completion: March 31, 2023
• Study Completion: July 1, 2023
• Last Updated: June 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)