Validation Study of the WatchPAT 200 in the Diagnosis of Obstructive Sleep Apnea in Children 4-12 Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Peripheral Arterial Tone Apnea-hypopnea Index (PAHI)
研究概览
简要总结
Validation study of a novel sleep Device compared to a traditional sleep study.
详细描述
This is an investigator-initiated validation study for the WatchPAT 200 device compared to the gold standard polysomnography procedure (sleep study). To evaluate the accuracy of the WatchPAT device compared to an in-laboratory Polysomnogram (PSG), measurements including obstructive apnea hypopnea index (OAHI), apnea hypopnea index (AHI), oxygen desaturation index (ODI) and other relevant sleep parameteres and indices will be compared. Ultimately, the diagnostic agreement of the WatchPAT device in detecting between normal sleep and mild sleep apnea architecture will be assessed.
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
盲法说明
Blinded to the subject's diagnosis
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 5 through 12 years of age.
- •Referral to the Sleep Lab due to concerns for Obstructive Sleep Apnea (OSA) and presenting with symptoms such as:
- •witnessed apneas,
- •daytime sleepiness, and
- •mouth breathing, etc.
- •Informed consent obtained.
排除标准
- •Medical conditions that can affect the tonometer reading such as:
- •peripheral vascular disease,
- •cyanotic heart disease,
- •systemic hypertension, and
- •sickle cell crisis.
- •Medical conditions that can potentially limit tolerance of the WatchPAT 200 device such as:
- •autism spectrum disorder,
- •Trisomy 21, and
- •neurodevelopmental disorders.
- •History of neuromuscular malformation
- •History of current supplemental oxygen use
- •History of current vasoactive, cardiac or seizure medication use
- •Inability or unwillingness to provide informed consent
结局指标
主要结局
Peripheral Arterial Tone Apnea-hypopnea Index (PAHI)
时间窗: Up to 10 hours
Compare the results to the subjects clinical sleep study results. The PAHI measures presence of sleep apnea. Scores are counts of respiratory events per hour. A score of more than 2 indicates obstructive sleep apnea. Mild = 2-4.9, Moderate = 5-9.9, Severe = 10 or more.
次要结局
- Oxygen Desaturation Index (ODI)(Up to 10 hours)
- Body Position(Up to 10 hours)
- Peripheral Arterial Tone Respiratory Disturbance Index (PRDI)(Up to 10 hours)
- Sleep Staging: Light and Deep(Up to 10 hours)
- Oxygen Saturation(Up to 10 hours)
- Heart Rate(Up to 10 hours)
- Sleep Time (Total)(Up to 10 hours)
- Sleep Staging: REM(Up to 10 hours)