跳至主要内容
临床试验/NCT03748771
NCT03748771已完成不适用

Validation of ApneaLink Air Home Sleep Testing in the Diagnosis of Obstructive Sleep Apnea in Adolescent Children

ResMed2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
ResMed
入组人数
20
试验地点
2
主要终点
Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography)

研究概览

简要总结

The feasibility and the validity of the ApneaLink Air home sleep testing (HST) device will be tested in adolescent children. The ApneaLink Air HST device is cleared for the diagnosis of obstructive sleep apnea (OSA) in adults..

详细描述

Obstructive sleep apnea is highly prevalent in children affecting 2-3% of children and up to 10% of obese children. The reported prevalence is likely underestimated due to the lack of available laboratory polysomnography (PSG) testing for children. The high prevalence of OSA coupled with an increase in obesity, a major risk factor of OSA in children, has resulted in a significant strain for in laboratory PSG including children in the greater San Diego county. Currently, HST in children is restricted based on the limited availability of HST devices on children that have attained clearance by the US Food and Drug Administration (FDA). In this study, the feasibility and the validity of the ApneaLink Air HST device will be tested in children 12 years old and over. The ApneaLink Air HST device is cleared for the diagnosis of OSA in adults and is frequently used amongst adult sleep medicine physicians. Adolescent children will be recruited whose clinically indicated in laboratory PSG will be performed at Rady Children's Hospital. Concurrent to their in-laboratory PSG, they will have their sleep assessed using the ApneaLink Air device. Ten children will repeat the ApneaLink Air HST at home following their sleep study within one week, and the remaining ten children will have their ApneaLink Air HST performed within one week prior to their in laboratory clinically indicated PSG.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients presenting with symptoms of OSA needing a sleep study
  • Patients between the ages of 12 and 17 years, inclusive

排除标准

  • Patients less than 12 years old
  • Patients 18 years old or older
  • Children with syndromes or congenital disease including Down Syndrome, Prader-Willi syndrome, children with craniofacial disorders, and finally children with congenital heart disease or pulmonary hypertension

结局指标

主要结局

Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography)

时间窗: Day 1

Accuracy is measured by ODI (oxygen desaturation index) and AHI (apnea hypopnea index) The ODI is defined as the number of episodes of oxygen desaturation per hour of sleep, with oxygen desaturation defined as a decrease in blood oxygen saturation (SpO2) to lower than 3% below baseline. The ODI is presented as an index to indicate the number of oxygen dips per hour of sleep. The AHI indicates the number of apneas or hypopneas which occured during the sleep study, divided by the hours of sleep. The AHI is an Index which indicates how many events occurred each hour

次要结局

  • Patient Satisfaction(Day 1)
  • Number of Successful HST Evaluations(Day 1)

研究者

发起方
ResMed
申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验