Validation of the French Version of the OSA-18 Questionnaire
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Scores on the French version of the OSA-18 questionnaire (total score)
研究概览
简要总结
Obstructive sleep apnea (OSA) is characterized by repetitive partial and/or total closure of the upper airway during sleep, inducing oxygen desaturation and sleep disturbance. Its prevalence in the pediatric population is 1-5%. In children, OSA can have negative consequences on the cardiovascular system and on the neurocognitive development. It is essential to diagnose OSA and to treat it efficiently.
The OSA-18 questionnaire assesses the symptômes of OSA in children and its repercussions. It is composed of 18 items scored on a Likert scale by caregivers. This system allows a more sensitive scoring than binary answers available in other questionnaires like the Pediatric Sleep Questionnaire.
The OSA-18 questionnaire would thus be an interesting tool to use for evaluating treatment efficacy in interventional studies and in clinical practice.
This questionnaire is not yet available in French. The main objective of this study is thus to evaluate the validity of a French version compared to the gold standard method to evaluate OSA: polysomnography.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children hospitalized in the Clinical Epileptology, Sleep Disorders, and Child Functional Neurology Department for polysomnography to screen for OSA,
- •Aged 4 to 17 years inclusive.
排除标准
- •Parents and/or children object to participation in the study.
- •Subjects participating in another intervention research study with an ongoing exclusion period.
研究组 & 干预措施
Children referred to the sleep clinic for polysomnography.
Children aged 4 to 17 years referred hospitalized in the sleep unit of the Hospices Civils de Lyon (France) for polysomnography, for a duration of 24 to 48h.
干预措施: Completion of the OSA-18 questionnaire by parents, during hospitalization planned as part of routine care. (Other)
结局指标
主要结局
Scores on the French version of the OSA-18 questionnaire (total score)
时间窗: Day 2
The OSA-18 questionnaire will be filled-in by caregivers.
次要结局
未报告次要终点