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Obstructive Sleep Apnea and Down Syndrome: Clinical Examination Issue

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ClinicalTrials.gov Identifier: NCT02732431
Recruitment Status : Completed
First Posted : April 8, 2016
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Lenval

Tracking Information
First Submitted Date  ICMJE March 22, 2016
First Posted Date  ICMJE April 8, 2016
Last Update Posted Date July 30, 2018
Actual Study Start Date  ICMJE October 10, 2013
Actual Primary Completion Date December 31, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02732431 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Obstructive Sleep Apnea and Down Syndrome: Clinical Examination Issue
Official Title  ICMJE Obstructive Sleep Apnea Screening and Down Syndrome in Childhood : the Reliability of the Clinical Examination
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Obstructive Sleep Apnea
Intervention  ICMJE Other: Sleep Symptom
Questionnaires, skin allergy test, overnight polysomnography
Study Arms  ICMJE trisomy 21
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.
Intervention: Other: Sleep Symptom
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2018)
17
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2016)
150
Actual Study Completion Date  ICMJE December 31, 2014
Actual Primary Completion Date December 31, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02732431
Other Study ID Numbers  ICMJE 14-HPNCL-06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fondation Lenval
Study Sponsor  ICMJE Fondation Lenval
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: lisa CHAMI, MD Hôpitaux Pédiatriques de Nice CHU-LENVAL
PRS Account Fondation Lenval
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP