Home Sleep Apnea Testing for the Evaluation of Obstructive Sleep Apnea in Children Following Management With Adenotonsillectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Correlation between obstructive apnea hypopnea index (OAHI) by HSAT vs PSG
研究概览
简要总结
This clinical trial will compare the diagnostic accuracy of type II HSAT with PSG for determining OSA status following treatment with adenotonsillectomy in children
详细描述
Many children have residual obstructive sleep apnea (OSA) following adenotonsillectomy, but in-lab polysomnography (PSG), the recommended means of re-evaluating these patients, is resource-intensive and availability is limited. Home sleep apnea testing (HSAT), a similar test performed in the patient's home and used clinically in adults, may offer an alternative means of evaluating the effect of OSA treatment in children and make testing more convenient and widely available.
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
- Single (Investigator)
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
- •History of adenotonsillectomy for OSA
排除标准
- •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
结局指标
主要结局
Correlation between obstructive apnea hypopnea index (OAHI) by HSAT vs PSG
时间窗: up to one month
Correlation will be assessed in all participants completing PSG and HSAT using the OAHI from both tests
次要结局
- Parent-reported preference between HSAT and PSG(up to one month)
- Correlation between OAHI from HSAT and score from OSA questionnaires(up to one month)
- Parent-reported acceptability of HSAT(up to one month.)
- Child-reported preference between HSAT and PSG(up to one month)