Efficacy of an Intranasal Stent on Nasal Obstruction at Night: A Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Nasal resistance in anterior rhinomanometry (sPa/ml/sec)
研究概览
简要总结
This study aims to demonstrate a decrease with normalization of nasal resistance in the forward decubital position and with an intra-nasal stent in patients with nasal obstruction.
详细描述
All patients consulting for nasal obstruction at night and who have functional nasal test with pathological resistance in decubitus position are included.
Functional nasal test (non invasive tests) will be performed before and after intranasal introduction of a stent: anterior rhinomanometry to measure nasal function by the measure of resistance and acoustic rhinometry to measure the geometry of nasal fossa by the measure of minimal sectional cross area sitting, after 30 minutes of decubitus then new measurements with a stent in decubitus position in each nostril .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volontary patient
- •Over 18 years old or more.
- •Complain of a nasal obstruction more important (or only) at night (in decubitus position)
排除标准
- •Unability to sign the consent form
- •Allergy of stent component
- •Perforation of nasal septum
- •Haemostasis disorder or anticoagulant therapy
- •Bilateral obstructive septal deviation ou polyposis induce inability to introduce the stent in the nasal cavities
结局指标
主要结局
Nasal resistance in anterior rhinomanometry (sPa/ml/sec)
时间窗: Day 15
Change grom Baseline of Nasal resistance in anterior rhinomanometry. Sitting, lying in the meadow and Per stent nasal.
次要结局
- Epworth Sleepiness Scale (ESS)(Day 15)
- Stent satisfaction(Day 15)
- Compliance(Day 15)
- Stent tolerance(Day 15)
- Nasal Obstruction and Septoplasty Effectiveness (NOSE)(Day 15)
- Analog visual scale (EVA) of nocturnal nasal obstruction(Day 15)
- Sino-Nasal Outcome Test 22 (SNOT-22) questionary(Day 15)