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Obstructive Sleep Apnea and Down Syndrome: Clinical Examination Issue

Obstructive Sleep Apnea Screening and Down Syndrome in Childhood : the Reliability of the Clinical Examination

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02732431
Enrollment
17
Registered
2016-04-08
Start date
2013-10-10
Completion date
2014-12-31
Last updated
2018-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

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.

Interventions

OTHERSleep Symptom

Questionnaires, skin allergy test, overnight polysomnography

Sponsors

Fondation Lenval
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
determine the reliability of the Sensitivity of four questionnaires used in paediatric patients in screening of OSA in DS populationAt the inclusionSensitivity 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

MeasureTime frameDescription
determine the reliability of positive predictive value of four questionnaires used in paediatric patients in screening of OSA in DS populationAt the inclusionpositive 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 populationAt the inclusionnegative 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 the specificity of four questionnaires used in paediatric patients in screening of OSA in DS populationAt the inclusionspecificity 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 populationAt the inclusionnegative 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 populationAt the inclusionarea 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.
determine the reliability of positive likelihood ratio of four questionnaires used in paediatric patients in screening of OSA in DS populationAt the inclusionpositive 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026