Obstructive Sleep Apnea and Down Syndrome: Clinical Examination Issue

NCT ID: NCT02732431

Last Updated: 2018-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-10
• Study Completion Date: 2014-12-31

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Sleep Symptom

Intervention Type: OTHER

Questionnaires, skin allergy test, overnight polysomnography

Interventions

Sleep Symptom

Questionnaires, skin allergy test, overnight polysomnography

Intervention Type: OTHER

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Lenval

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

lisa CHAMI, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Pédiatriques de Nice CHU-LENVAL

Locations

CHU de Nice

Nice, Alpes-Maritimes, France

Countries

France

Other Identifiers

14-HPNCL-06

Identifier Type: -

Identifier Source: org_study_id