A Clinical Study to Evaluate the Effectiveness of Combined Use of Two Nasal Protective Medical Devices (Noseguard and Noseguard Night) for Reducing Respiratory Infection Rates and Assessing Usability
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Incidence of Respiratory Infection
研究概览
简要总结
This study is a prospective clinical study to evaluate the effectiveness of combined use of two nasal protective medical devices (Noseguard and Noseguard Night) in reducing respiratory infection rates, including COVID-19 and influenza, in real-world conditions.
The study will also assess usability, satisfaction, and safety using electronic patient-reported outcomes (ePRO).
详细描述
This study is a prospective clinical study conducted in Korea to evaluate the effectiveness of combined use of two nasal protective medical devices, Noseguard and Noseguard Night, for preventing respiratory infections.
A total of approximately 2,000 adult participants will be enrolled and followed for 8 weeks. Participants will use Noseguard during daytime activities and Noseguard Night before sleep.
Data will be collected using electronic patient-reported outcomes (ePRO) at baseline and at Weeks 2, 4, 6, and 8. The primary endpoint is the incidence of respiratory infections, including COVID-19 and influenza.
Secondary endpoints include symptom severity, duration of symptoms, usability, satisfaction, and safety outcomes such as adverse events.
This study aims to generate real-world evidence on the effectiveness and usability of nasal protective devices for respiratory infection prevention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥19 years
- •Able to provide informed consent
排除标准
- •Hypersensitivity to device components
- •Current COVID-19 or influenza infection
- •Severe nasal disease
- •Pregnant or breastfeeding women
研究组 & 干预措施
Noseguard Combined Use
Participants will use Noseguard during daytime activities and Noseguard Night before sleep for 8 weeks.
干预措施: Noseguard and Noseguard Night (Device)
结局指标
主要结局
Incidence of Respiratory Infection
时间窗: Week 8
Incidence of respiratory infections, including COVID-19 and influenza, during the 8-week study period.
次要结局
- Incidence of Respiratory Infection by Interval(Up to Week 8)