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NCT Number: NCT02732431

Obstructive Sleep Apnea and Down Syndrome: Clinical Examination Issue

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.

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Key information

Conditions

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

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, Alpes-Maritimes, 06000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Symptom

Other

Questionnaires, skin allergy test, overnight polysomnography

Primary outcomes

  1. determine the reliability of the Sensitivity of four questionnaires used in paediatric patients in screening of OSA in DS population

    Time frame: 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 outcomes

  1. determine the reliability of the specificity of four questionnaires used in paediatric patients in screening of OSA in DS population

    Time frame: 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.

  2. determine the reliability of positive predictive value of four questionnaires used in paediatric patients in screening of OSA in DS population

    Time frame: 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.

  3. determine the reliability of negative predictive value of four questionnaires used in paediatric patients in screening of OSA in DS population

    Time frame: 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.

  4. determine the reliability of positive likelihood ratio of four questionnaires used in paediatric patients in screening of OSA in DS population

    Time frame: 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.

  5. determine the reliability of negative likelihood ratio of four questionnaires used in paediatric patients in screening of OSA in DS population

    Time frame: 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.

  6. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fondation Lenval

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 8, 2016
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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