Home Sleep Apnea Testing Compared to In-lab Polysomnography for the Evaluation of Obstructive Sleep Apnea in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 317
- 试验地点
- 2
- 主要终点
- Proportion of participants with diagnosis of OSA on both HSAT and PSG
研究概览
简要总结
This clinical trial will compare home sleep apnea testing with the gold standard in-lab polysomnography in terms of 1) accuracy, 2) therapeutic decision-making, and 3) parent/child acceptability in children referred for evaluation of obstructive sleep apnea.
详细描述
In-lab attended polysomnography (PSG) is recommended for the diagnosis of obstructive sleep apnea (OSA) in children, but testing is limited by high cost and limited facilities. 90% of children who undergo adenotonsillectomy to treat OSA never have the diagnosis made by PSG. Home sleep apnea testing (HSAT) is an accepted means of evaluating adults for OSA. However, in children there is insufficient evidence comparing HSAT to PSG, so it is not currently recommended in the pediatric population. This single-center comparative effectiveness trial will compare the diagnostic accuracy of HSAT with PSG and will assess the agreement in therapeutic decision-making between the two tests and parent- and child-reported acceptability of HSAT and preference of test.
Participants will be randomized to the initial test (HSAT or PSG) and then complete the alternate test within one week. Off-site investigators who are pediatric sleep medicine physicians will provide a therapeutic decision based on clinical data and either HSAT or PSG data, and families will complete questionnaires assessing acceptability of HSAT and preference between the two tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigators will be masked as to the order of the two sleep tests
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female children age 5-12 years old inclusive
- •Referred for diagnostic PSG at the Children's Hospital of Philadelphia (CHOP) Sleep Laboratory for evaluation of OSA as part of clinical care
- •Parental/guardian permission (informed consent) and if appropriate, child assent.
排除标准
- •Children without Down syndrome who have had a PSG within 3 years of enrollment
- •Children with Down syndrome who have had a PSG within 1 year of enrollment.
- •Children with a history of hypoventilation or hypoxemia or who require supplemental oxygen or positive airway pressure during sleep
- •Children with a tracheostomy or tracheocutaneous fistula
- •Children who live in a facility without their parent
研究组 & 干预措施
HSAT first
Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography
干预措施: Home sleep apnea test (Diagnostic Test)
PSG first
Participants will be randomized to undergo HSAT after receiving their clinical, in-lab polysomnography.
干预措施: In-lab polysomnography (Diagnostic Test)
结局指标
主要结局
Proportion of participants with diagnosis of OSA on both HSAT and PSG
时间窗: 2 weeks
Obstructive sleep apnea (OSA) defined as an obstructive apnea hypopnea index of greater than 2 events/hour on both home sleep apnea test (HSAT) and polysomnography (PSG).
次要结局
- Association between therapeutic decision from HSAT compared to PSG(2 weeks)
- Proportion of participants who prefer HSAT to PSG(2 weeks)
- Correlation between obstructive apnea hypopnea index (OAHI) of HSAT compared to PSG(2 weeks)