Evaluation of Obstructive Sleep Apnea With Long Range 3D Endoscopic Fourier Domain Optical Coherence Tomography (FDOCT)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- obstructive upper airways in sleep disordered
研究概览
简要总结
The purpose of this study is to determine whether the Optical coherence tomography (OCT) can image the structure and geometry of hollow organs of the upper airway in sleep disorder. The research can identify the obstruction sites that help the select the appropriate treatment for potential surgical candidates.
详细描述
The National Commission on Sleep Disorders Research estimated that 18 million Americans suffer from obstructive sleep apnea (OSA) The majority of them are undiagnosed and untreated at this time.
The current diagnostic gold standard for OSA is in-laboratory, a full night polysomnography (PSG). However, PSG is unable to provide information on upper airway structure and anatomy, and cannot identify the obstruction sites. OSA can lead to severe health complications including hypertension, heart failure, memory impairment, motor vehicle and work accidents, decreased work productivity, and increased risk of death.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female age 18-65 years has no history of obstructive sleep apnea
- •Male or Female age 18-65 years has been diagnose of mild to moderate obstructive sleep apnea
- •Male or Female age 18-65 years has been diagnose severe obstructive sleep apnea
排除标准
- •Pregnant women.
- •Breastfeeding women.
- •Unable to understand or give consent to the study.
- •Currently taking drugs that are sensitive to light.
- •Currently taking routine anti-convulsion, sedative or antihistamine drugs.
- •Currently taking immuno-suppressive drug therapy.
结局指标
主要结局
obstructive upper airways in sleep disordered
时间窗: 8 hours
The OCT can provide information on upper airway structure and anatomy, and identify the obstruction sites.
次要结局
未报告次要终点
研究者
Beckman Laser Institute and Medical Center
Jun Zhang, PhD, Assistant Project Scientist
University of California, Irvine