NCT04910139已完成不适用
A User Study of the Soniflow System for Nasal Congestion Relief
Third Wave Therapeutics2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年7月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Total Nasal Symptom Score
研究概览
简要总结
The Soniflow System consists of an acoustic vibrational headband paired with a Smartphone App to provide rapid relief of nasal congestion.
详细描述
The Soniflow System is a non-invasive device to provide rapid relief of nasal congestion. It consists of a headband with ultrasound transducers (hardware) coupled to a Smartphone application (software).
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
- 是
入选标准
- •Subject is >18 years of age
- •Subject has had moderate to severe symptoms of nasal congestion for >3 months (TNSS rating of 2 or 3)
- •Subject has signed IRB-approved informed consent form
排除标准
- •Subject has neurologic comorbidities
- •Subject has active dental infection
- •Subject is pregnant
- •Subject has implanted intracranial electrostimulation device(s) (e.g. cochlear implant, deep brain stimulator)
- •Subject has undergone sinonasal or craniomaxillofacial surgery within the lats 3 months
- •Subject has been diagnosed with intracranial hemorrhage within the last 6 months
- •Subject has open scalp wounds or rashes
- •Subject has any history of craniotomy without replacement of a bone flap
- •Subject has elevated sensitivity to sound
- •Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk
结局指标
主要结局
Total Nasal Symptom Score
时间窗: 20 minutes
TNSS is a measure of nasal congestion, measured as the sum of four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe). The minimum TNSS value is 0. The maximum TNSS value is 12. Lower TNSS score means a better outcome
次要结局
- Visual Analog Scale (VAS) for Headache(20 minutes)
- Visual Analog Scale (VAS) for Facial Pain(20 minutes)
研究者
研究点 (2)
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