Exploratory and safety study: Modulation of the cough reflex using ultrasonically nebulised distilled water (UNDW) in healthy participants.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
In this study, we wanted to know whether we could safely modulate and enhance cough sensitivity using inhalations of distilled water. The distilled water senosory stimulation protocol was designed as a potential treatment for silent aspiration, where individuals aspirate due to a lack of sensation in their throat. We wanted to determine if the sensory stimulation protocol was safe on pulmonary function and whether it could modulate cough sensitivity. We recruited 28 healthy volunteers to undergo the distilled water sensory stimulation protocol. Four participants were excluded, as they were not suitable to participate in the study. A total of 24 individuals, 8 per group, were included in the final analysis. The distilled water sensory stimulation protocol did not induce narrowing of the airways (i.e. bronchoconstriction) in any participant. Cough sensitivity changed differently across days in the high and low-intensity sensory stimulation groups, compared to the control group. In the control group, cough sensitivity increased across days. This is what we expect when we repeat the citric acid cough reflex test across days. In contrast, an absence of habituation to citric acid CRT was observed following both of the sensory stimulation protocols, suggesting an increase in cough sensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •Participants must be healthy and capable of providing informed, written consent to participate.
排除标准
- •History of asthma, neurological disorders, respiratory diseases or gastro-esophageal reflux.
- •Any participants ACE inhibitor drugs, codeine, smoking, or have had a upper respiratory chest infection in the past 2 weeks..
