The Effect of Suggestion of Harmful/Beneficial Effects of Odors on Asthma Symptoms
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change from Baseline Exhaled Nitric Oxide to 24 hours after odor induction
研究概览
简要总结
An extended replication of Jaen & Dalton (2014), the investigators aim to investigate the role of odors and associated trigger beliefs on symptom perception and airway inflammation in individuals with asthma
详细描述
Participants with asthma are randomly assigned to a 15-min (phenylethyl alcohol) odor inhalation, accompanied by either an asthmogenic suggestion (nocebo), or a therapeutic suggestion (placebo). Airway inflammation, lung function, and asthma symptoms are measured in response to the odor/suggestion, up to 24 hours after odor inhalation. The investigators are also measuring worry and heart rate variability as potential mediators of the response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A physician diagnosis of asthma
排除标准
- •FEV1 lower than 60% predicted
- •clinical condition other than asthma
结局指标
主要结局
Change from Baseline Exhaled Nitric Oxide to 24 hours after odor induction
时间窗: baseline, immediately after odor induction, 2 hours after odor induction, 24 hours after odor induction
Fraction of exhaled nitric oxide
次要结局
- Cortisol(baseline, immediately after odor induction, 2 hours after odor induction, at awakening, 30 min after awakening, 24 hours after odor induction)
- asthma symptoms(baseline, immediately after odor induction, 2 hours after odor induction, 24 hours after odor induction)
- Forced Expiratory Volume at one second (FEV1)(baseline, immediately after odor induction, 2 hours after odor induction, 24 hours after odor induction)
- Change in Heart rate and Heart Rate Variability (HRV)(change from baseline to 24 hours after odor induction)
- Worry(baseline, immediately after odor induction, 2 hours after odor induction, 24 hours after odor induction)
- change in Fraction of end-tidal carbon dioxide (FetCO2)(change from baseline to 15 min odor presentation)
- Change in Respiratory rate(change from baseline to 15 min odor presentation)