Obstructive Sleep Apnea and Down Syndrome: Clinical Examination Issue

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732431
• Other study ID #: 14-HPNCL-06
• Status: Completed
• Phase: N/A
• Start date: October 10, 2013
• Est. completion date: December 31, 2014

Study information

• Verified date: July 2018
• Source: Fondation Lenval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 31, 2014
• Est. primary completion date: December 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Down Syndrome
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Sleep Symptom
Questionnaires, skin allergy test, overnight polysomnography

Locations

Country	Name	City	State
France	CHU de Nice	Nice	Alpes-Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Lenval

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determine the reliability of the Sensitivity of four questionnaires used in paediatric patients in screening of OSA in DS population	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.	At the inclusion
Secondary	determine the reliability of the specificity of four questionnaires used in paediatric patients in screening of OSA in DS population	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.	At the inclusion
Secondary	determine the reliability of positive predictive value of four questionnaires used in paediatric patients in screening of OSA in DS population	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.	At the inclusion
Secondary	determine the reliability of negative predictive value of four questionnaires used in paediatric patients in screening of OSA in DS population	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.	At the inclusion
Secondary	determine the reliability of positive likelihood ratio of four questionnaires used in paediatric patients in screening of OSA in DS population	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.	At the inclusion
Secondary	determine the reliability of negative likelihood ratio of four questionnaires used in paediatric patients in screening of OSA in DS population	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.	At the inclusion
Secondary	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	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.	At the inclusion