Clinical trial NCT02732431: Obstructive Sleep Apnea and Down Syndrome: Clinical Examination Issue
Official title: Obstructive Sleep Apnea Screening and Down Syndrome in Childhood : the Reliability of the Clinical Examination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2016-04-08
Enrollment: 17
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: determine the reliability of the Sensitivity of four questionnaires used in paediatric patients in screening of OSA in DS population
timeFrame: At the inclusion
Secondary outcomes:
measure: determine the reliability of the specificity of four questionnaires used in paediatric patients in screening of OSA in DS population
timeFrame: At the inclusion
measure: determine the reliability of positive predictive value of four questionnaires used in paediatric patients in screening of OSA in DS population
timeFrame: At the inclusion
measure: determine the reliability of negative predictive value of four questionnaires used in paediatric patients in screening of OSA in DS population
timeFrame: At the inclusion
measure: determine the reliability of positive likelihood ratio of four questionnaires used in paediatric patients in screening of OSA in DS population
timeFrame: At the inclusion
measure: determine the reliability of negative likelihood ratio of four questionnaires used in paediatric patients in screening of OSA in DS population
timeFrame: At the inclusion
measure: 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
timeFrame: At the inclusion
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
state: Alpes-Maritimes
Study officials:
affiliation: Hôpitaux Pédiatriques de Nice CHU-LENVAL
name: lisa CHAMI, MD
role: PRINCIPAL_INVESTIGATOR
References: