Obstructive Sleep Apnea and Down Syndrome: Clinical Examination Issue

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Other: Sleep Symptom

• Registration Number: NCT02732431
• Lead Sponsor: Fondation Lenval

Brief Summary

Obstructive sleep apnea (OSA) is a common condition of Down syndrome patients. In pediatric practice, there is no way to determine the children with an increased risk. The aim of the study is to determine the reliability of four questionnaires used in pediatric patients in screening of OSA in Down syndrome children.

Prospective study where patients are evaluated on airway diseases and aeroallergens sensitization with 2 parental surveys (PSQ-SRBD and CSHQ), otolaryngologic problems by completing by the ENT surgeon 2 others surveys (CAS-15 and SCR), and sleep disease with an overnight polysomnography (PSG), in University Hospital in Nice.

Detailed Description

Introduction: Children with Down syndrome (DS) commonly have obstructive sleep apnea (OSA) though undervalued by parents and physicians. Several sleep questionnaires are used in paediatric patients to detect high risk children who have OSA, but not really appropriate for DS patients. The aim of the study is to determine the reliability of four questionnaires used in paediatric patients (PSQ-SRBD: Pediatric Sleep Questionnaire-Sleep-Related Breathing Disorder, CSHQ: Children's Sleep Habits Questionnaire, CAS-15: Clinical Assessment Score-15 and SCR: Sleep Clinical Record) in screening of OSA in DS population.

Study design: Prospective study concerning children with Down syndrome (age 1-18y). Parents will complete two sleep symptom questionnaires (PSQ-SRBD and CSHQ) and children will be evaluated by a paediatric pulmonologist and allergist with skin allergy test. An Ear, Nose and Throat specialist will complete two questionnaires (CAS-15 and SCR) carrying a nasopharyngoscopy. Then, children will perform an overnight polysomnography in the Department of Paediatric Functional Investigations of University Hospital in Nice.

Study Timeline

• Study Start: 2013-10-10
• Primary Completion: 2014-12-31
• Study Completion: 2014-12-31
• Study First Submitted: 2016-03-22
• Study First Submitted QC: 2016-04-04
• Study First Posted: 2016-04-08
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-27
• Last Update Posted: 2018-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Age under 18 years
• Down syndrome with cytogenetic diagnosis
• State health cover
• Consent of legal representative and/or patient

Exclusion Criteria

• Polysomnography with correct results during the 12 months before

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
trisomy 21	Sleep Symptom	Parents will complete two sleep symptom questionnaires (PSQ-SRBD and CSHQ) and children will be evaluated by a paediatric pulmonologist and allergist with skin allergy test. An Ear, Nose and Throat specialist will complete two questionnaires (CAS-15 and SCR) carrying a nasopharyngoscopy. Then, children will perform an overnight polysomnography in the Department of Paediatric Functional Investigations of University Hospital in Nice.

Primary Outcome Measures

Name	Time	Method
determine the reliability of the Sensitivity of four questionnaires used in paediatric patients in screening of OSA in DS population	At the inclusion	Sensitivity each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.

Secondary Outcome Measures

Name	Time	Method
determine the reliability of the specificity of four questionnaires used in paediatric patients in screening of OSA in DS population	At the inclusion	specificity of each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.
determine the reliability of positive predictive value of four questionnaires used in paediatric patients in screening of OSA in DS population	At the inclusion	positive predictive value of each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.
determine the reliability of negative predictive value of four questionnaires used in paediatric patients in screening of OSA in DS population	At the inclusion	negative predictive value of each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.
determine the reliability of positive likelihood ratio of four questionnaires used in paediatric patients in screening of OSA in DS population	At the inclusion	positive likelihood of each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.
determine the reliability of negative likelihood ratio of four questionnaires used in paediatric patients in screening of OSA in DS population	At the inclusion	negative likelihood ratio of each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.
determine the reliability of area under a receiver operating characteristic (ROC) curve of four questionnaires used in paediatric patients in screening of OSA in DS population	At the inclusion	area under a receiver operating characteristic (ROC) curve of each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, Alpes-Maritimes, France