Breath Metabolomics of Placebo Effects Via Cold Pressor Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- change in signal intensity of mass-to-charge ratio (m/z) of exhaled metabolites
研究概览
简要总结
This study is to analyze the breath metabolome before and after the administration of a placebo in an established experimental pain procedure in healthy subjects in order to investigate placebo effects, and whether they induce any measurable changes at the metabolic level.
详细描述
Interrogation of the exhaled breath metabolome will be performed by using an objective method of measurement for placebo effects in pain analgesia, known as Cold Pressure Test (CPT). CPT reactions can be measured objectively by blood pressure spikes as well as changes in continuous heart rate monitoring.To this end, probands will be continuously connected to a Heartrate & Blood Pressure Monitor. First, baseline exhalation will be assessed. Then, the CPT is performed according to the 'CPT Guide' with subsequent post-pain exhalations analysis with or without self-administration of the placebo (NaCl nasal spray). After 15 minutes rest, probands will be submitted to a second post-pain exhalations set (+/- placebo). The process is completely non-invasive as the participant just exhales through a commercially available disposable bacterial/viral filter coupled to the ion source.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
participants do not know its a placebo
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female and male adult volunteers
- •German speaking, or good knowledge of the German language
- •Able to understand the study
- •Able to give informed consent
排除标准
- •Regularly taking medication potentially interfering with pain sensation (analgesics, antihistamines and calcium and potassium channel blockers)
- •Current pregnancy
- •Daily smokers (as per WHO definition: A daily smoker is someone who smokes any tobacco product at least once a day.)
- •Neuropathy
- •Chronic pain
- •Neuromuscular or psychiatric disease
- •Known or suspected heart, kidney or liver disease
- •Hypertension (Systolic (mmHg) >130, Diastolic (mmHg) >80)
- •History of fainting or seizures
- •History of Frostbite
- •Current medications (psychoactive medication, narcotics, intake of analgesics) or being currently in psychological or psychiatric treatment.
研究组 & 干预措施
CPT first
Cold Pressor Test (CPT): apparatus for the task is a tank of water of temperature of 4 °C (+-0.5 °C), with instruction to immerse the hand until too uncomfortable to continue. A maximum time limit per immersion of 3-5 min is applied. Quantitative measurement can then be made of pain threshold (point first perceived as painful) and tolerance time.
All 20 participants will undergo two study visits. The order in which they will receive CPT and CPT plus placebo differs, with participants being randomly split into two groups. 10 participants first CPT + placebo and then CPT, and 10 participants vice versa.
干预措施: Cold Pressor Test (CPT) (Other)
CPT first
Cold Pressor Test (CPT): apparatus for the task is a tank of water of temperature of 4 °C (+-0.5 °C), with instruction to immerse the hand until too uncomfortable to continue. A maximum time limit per immersion of 3-5 min is applied. Quantitative measurement can then be made of pain threshold (point first perceived as painful) and tolerance time.
All 20 participants will undergo two study visits. The order in which they will receive CPT and CPT plus placebo differs, with participants being randomly split into two groups. 10 participants first CPT + placebo and then CPT, and 10 participants vice versa.
干预措施: Placebo NaCl Nasal spray (Other)
CPT+placebo first
Participant will be told and read about the 'pain medication' (= Placebo NaCl Nasal spray). Thereafter participant will self-administer a nasal spray, which is in fact a placebo nasal spray containing NaCl solution and Cold Pressor Test (CPT) is performed.
All 20 participants will undergo two study visits. The order in which they will receive CPT and CPT plus placebo differs, with participants being randomly split into two groups. 10 participants first CPT + placebo and then CPT, and 10 participants vice versa
干预措施: Cold Pressor Test (CPT) (Other)
CPT+placebo first
Participant will be told and read about the 'pain medication' (= Placebo NaCl Nasal spray). Thereafter participant will self-administer a nasal spray, which is in fact a placebo nasal spray containing NaCl solution and Cold Pressor Test (CPT) is performed.
All 20 participants will undergo two study visits. The order in which they will receive CPT and CPT plus placebo differs, with participants being randomly split into two groups. 10 participants first CPT + placebo and then CPT, and 10 participants vice versa
干预措施: Placebo NaCl Nasal spray (Other)
结局指标
主要结局
change in signal intensity of mass-to-charge ratio (m/z) of exhaled metabolites
时间窗: 1 hour
The variable of primary interest is the variation of signal intensity of mass-to-charge ratio (m/z) of exhaled metabolites.
次要结局
未报告次要终点