Obstructive Sleep Apnea Screening and Down Syndrome in Childhood : the Reliability of the Clinical Examination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- determine the reliability of the Sensitivity of four questionnaires used in paediatric patients in screening of OSA in DS population
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age under 18 years
- •Down syndrome with cytogenetic diagnosis
- •State health cover
- •Consent of legal representative and/or patient
排除标准
- •Polysomnography with correct results during the 12 months before
研究组 & 干预措施
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.
干预措施: Sleep Symptom (Other)
结局指标
主要结局
determine the reliability of the Sensitivity of four questionnaires used in paediatric patients in screening of OSA in DS population
时间窗: 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.
次要结局
- 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)
- 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(At the inclusion)