NL-OMON50116撤回不适用
The use of nasal airway stent (Nastent R) in patients with sleep-disordered breathing (SDB) including snoring and/or obstructive sleep apnea (OSA). - NASTENT trial
astent, inc0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •AHI < 20 per hour of sleep
- •Complaints of socially disturbing snoring by partner
- •Capable of giving informed consent
排除标准
- •- Craniofacial deformities
- •- Acute nasal trauma, fracture (during past 3 months)
- •- Nasal valve collapse, synechiae and septal perforation, recurrent epistaxis,
- •recent nasopharyngeal surgery, chronic rhinosinusitis with or without polyposis
- •- Cerebrospinal fluid leaks
- •- History of past or current psychiatric disorders (psychotic illness, major
- •depression, or acute anxiety attacks as mentioned by the patient), intellectual
- •disability, memory disorders, seizure disorders, neuromuscular disorders,
- •cardiovascular diseases, coagulopathies (thrombocytopenia< 100/µl), lower
- •respiratory tract disorders.
- •- Pregnancy or willing to become pregnant
- •- Excessive alcohol or drug use (>20 alcohol units/week or any use of hard
- •- Sleep medication use
研究者
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