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临床试验/NCT04340310
NCT04340310Unknown不适用

Usefulness of Home Respiratory Polygraphy in the Diagnosis and Therapeutic Decision of Childhood Sleep Apnea-Hypopnea Syndrome

Hospital Universitario San Juan de Alicante1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2019年2月6日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
125
试验地点
1
主要终点
To assess the diagnostic utility of home respiratory polygraphy (HRP) complemented with polysomnography (PSG) in childhood Obstructive Sleep Apnea-Hypopnea Syndrome (OSAS), as well as its usefulness in the therapeutic decisions.

研究概览

简要总结

The aims of the study is to assess the diagnostic utility of home respiratory polygraphy (HRP) complemented with polysomnography (PSG) in childhood Obstructive Sleep Apnea-Hypopnea Syndrome (OSAS), as well as its usefulness in the therapeutic decisions.

Methods: Children referred with suspected OSAS will be evaluated during one year performing home respiratory polygraphy in all cases. PSG will be chosen in patients with concomitant pathology or according to medical criteria, or complemented with HRP in doubtful cases. Clinical and anthropometric data, severity, technical quality and treatment will be obtained. Patients will be divided in two groups (HRP vs PSG) and compared, and the accuracy from HRP to establish a therapeutic decision it wil calculated. The investigator's hypothesis is that PSG should be recommended only for complex or doubtful cases.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
4 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Sleep apnea suspicion

排除标准

  • Other sleep conditions
  • Non valid home respiratory polygraphy and non valid polysomnography in the same patient
  • Non informated consent

结局指标

主要结局

To assess the diagnostic utility of home respiratory polygraphy (HRP) complemented with polysomnography (PSG) in childhood Obstructive Sleep Apnea-Hypopnea Syndrome (OSAS), as well as its usefulness in the therapeutic decisions.

时间窗: two years

False negative and true positive diagnosis by home respiratory polygraphy

次要结局

  • To assess the prevalence of childhood sleep apnea in Pneumology hospital consultations(two years)

研究者

发起方
Hospital Universitario San Juan de Alicante
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eusebi Chiner

Head of Pneumology

Hospital Universitario San Juan de Alicante

研究点 (1)

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