NCT05821842已完成不适用
Sonu Nasal COngestion RElief Study (SCORE)
Third Wave Therapeutics2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2022年3月23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
- 52
- 试验地点
- 2
- 主要终点
- Primary Effectiveness
研究概览
简要总结
To demonstrate the safety and effectiveness of Sonu for the treatment of patients suffering from moderate to severe nasal congestion.
详细描述
Sonu consists of and acoustic vibrational headband worn circumferentially at the level of the forehead. A smart phone App, paired to the headband, delivers acoustic resonant frequencies of the subject's nasal cavity through the headband and provides relief. Sonu is intended to be used for the treatment of moderate to severe nasal congestion due to rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double blinded
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
- •18 years of age and older
- •Present with symptoms of nasal congestion for 1 month or more prior to treatment
- •Have a 24 hour reflective nasal congestion subscore of the TNSS of 2 or more on a 0 to 3 scale at the time of screening
排除标准
- •Head, nasal or sinus surgery within 3 months
- •Sinus infection diagnosed within the last month, or rhinitis medicamentosa
- •Documented history of nasal polyposis or mass
结局指标
主要结局
Primary Effectiveness
时间窗: 2 weeks
Change in nasal congestion sub-score compared to baseline. The nasal congestion sub-score is reported on a scale of 0-3. 0 is the minimum and 3 is the maximum. Higher scores mean worse outcomes.
次要结局
- Secondary Effectiveness(2 weeks)
研究者
研究点 (2)
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