NCT07334444招募中不适用
Current Status Assessment for the Development of a Protocol to Optimize the Management of Obstructive Sleep Apnea (OSA) in Children With Down Syndrome
University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月19日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Apnea-hypopnea index (AHI) before and after surgery.
研究概览
简要总结
The objective of this retrospective descriptive study is to assess current practices for the screening and surgical treatment of OSA in children with Down syndrome at the Strasbourg University Hospital and to disseminate a management algorithm in France.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child with Down syndrome,
- •Aged between 0 and 17 years,
- •Having been seen for an ENT consultation at the University Hospital or the Sleep Center of the University Hospital of Strasbourg between January 1, 2019, and December 31, 2024
排除标准
- •- Presence of a written objection in the medical file of the subject (and/or their representative) to the reuse of their data for scientific research purposes.
结局指标
主要结局
Apnea-hypopnea index (AHI) before and after surgery.
时间窗: Day 1 before surgery and Day 1 after surgery
The AHI is a number that indicates how many times per hour breathing is abnormal during sleep. It adds up: * Apneas → breathing stops completely * Hypopneas → breathing becomes much shallower Scores: * AHI \< 5 → normal * AHI between 5 and 15 → mild impairment * AHI between 15 and 30 → moderate impairment
次要结局
未报告次要终点
研究者
研究点 (1)
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