Obstructive Sleep Apnea and Down Syndrome: Clinical Examination Issue

NCT02732431 | Completed

• 1 other identifier: 14-HPNCL-06
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  At the inclusion

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

  At the inclusion

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

  At the inclusion

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

  At the inclusion

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

  At the inclusion

Study Arms (1)

trisomy 21

OTHER

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.

Other: Sleep Symptom

Interventions

Sleep Symptom OTHER

Questionnaires, skin allergy test, overnight polysomnography

trisomy 21

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age under 18 years
• Down syndrome with cytogenetic diagnosis
• State health cover
• Consent of legal representative and/or patient

You may not qualify if:

• Polysomnography with correct results during the 12 months before

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

CHU de Nice

Nice, Alpes-Maritimes, 06000, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• lisa CHAMI, MD

  Hôpitaux Pédiatriques de Nice CHU-LENVAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 8, 2016
• Study Start: October 10, 2013
• Primary Completion: December 31, 2014
• Study Completion: December 31, 2014
• Last Updated: July 30, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)