Evaluating the Feasibility and Reliability of Using Handheld Nebulizers to Conduct Cough Sensitivity Testing With Citric Acid
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Test-retest reliability of the concentration of citric acid that elicits two or more coughs (C2)
研究概览
简要总结
Objective cough reflex sensitivity testing is typically restricted to specialized research laboratories due to reliance on expensive dosimeter-controlled aerosol delivery systems. This study evaluates the feasibility and reliability of a low-cost alternative method using a handheld nebulizer for citric acid cough challenge testing. Healthy adult participants will complete cough reflex sensitivity testing using both a standard dosimeter-controlled nebulizer system (Cosmed QuarkSpiro) and a handheld nebulizer (DeVilbiss 45). The study will compare cough threshold outcomes between methods to determine whether handheld nebulizer-based testing produces comparable and reproducible measurements.
详细描述
Cough reflex sensitivity testing is widely used in respiratory research to quantify airway sensory responsiveness. Traditional testing protocols use dosimeter-controlled nebulizer systems to deliver precise concentrations of aerosolized tussive agents such as citric acid. However, these systems are costly and require specialized laboratory infrastructure, limiting access to objective cough testing in outpatient and community-based settings.
This study investigates the feasibility and reliability of using a commercially available handheld nebulizer as a low-cost alternative for cough reflex sensitivity testing. Healthy adult volunteers will undergo standardized cough challenge testing using citric acid delivered through two aerosol delivery systems: a laboratory dosimeter-controlled nebulizer (Cosmed QuarkSpiro) and a handheld nebulizer (DeVilbiss 45). The primary outcomes will be cough threshold measures (e.g., C2 and C5), defined as the citric acid concentration that elicits two or five coughs.
Participants will complete testing sessions using both delivery methods under controlled conditions. Findings from this proof-of-concept study will inform future research aimed at expanding access to objective cough assessment in clinical and community settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults at least 18 years of age
- •Consent to audio/video recording of the research sessions for research purposes
- •Spirometry testing results obtained by study team on same day of first testing session with FEV1/FVC ratio and FEV1 percent predicted values of at least 0.70
排除标准
- •Pregnant or trying to become pregnant (if capable of becoming pregnant- a urine pregnancy test will be provided onsite and a negative result must be obtained prior to the first testing session)
- •Smoking of any substance in the last six months
- •Diagnosed or suspected pulmonary disease (e.g., asthma, COPD)
- •History of chronic cough
- •History of head or neck cancer
- •History of neurological disease (e.g., cerebrovascular accident)
- •History of dysphagia (swallowing difficulty)
- •Current complaint of a voice problem
- •Current upper respiratory infection
研究组 & 干预措施
Dosimeter-Controlled Cough Reflex Sensitivity Testing
Participants will undergo cough reflex sensitivity testing using a dosimeter-controlled nebulizer system (Cosmed QuarkSpiro) to deliver aerosolized citric acid.
干预措施: Cosmed QuarkSpiro Dosimeter-Controlled Nebulizer (Device)
Handheld Nebulizer Cough Reflex Sensitivity Testing
Participants will undergo cough reflex sensitivity testing using a handheld nebulizer (DeVilbiss 45) to deliver aerosolized citric acid.
干预措施: DeVilbiss 45 Handheld Nebulizer (Device)
结局指标
主要结局
Test-retest reliability of the concentration of citric acid that elicits two or more coughs (C2)
时间窗: Cough sensitivity testing to determine cough thresholds (C2) will be performed at each of four weekly study visits, with visits occurring every 7 days across a 4-week study period.
The test-retest reliability (Intraclass correlation coefficient) of the citric acid concentration required to elicit two coughs during cough challenge testing will be evaluated and compared for each testing method.
Test-retest reliability of the concentration of citric acid that elicits five or more coughs (C5)
时间窗: Cough sensitivity testing to determine cough thresholds (C5) will be performed at each of four weekly study visits, with visits occurring every 7 days across a 4-week study period.
The test-retest reliability (Intraclass correlation coefficient) of the citric acid concentration required to elicit five coughs during cough challenge testing will be evaluated and compared for each testing method.
次要结局
未报告次要终点