Investigation of the Effects of Sleep Provocations on Itch and Pain Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Assessment of itch
研究概览
简要总结
In This experiment, the investigators would like to test following hypotheses regarding the influence of sleep fragmentation on itch:
- To investigate similarity and differences between itch and pain by comparing the effect of sleep deprivation in them.
- To evaluate the inflammatory state induced by sleep fragmentation via the analysis of C-reactive protein (CRP) levels from blood samples.
- To correlate the anxiety and depression scores (evaluated through questionnaires) with itch and pain sensitivity and evaluate how they are affected by sleep fragmentation.
详细描述
Chronic itch affects approximately a fifth of the global population and is associated with substantial negative consequences for the affected individuals. Furthermore, there is a lack of efficient treatment options for chronic itch.
Poor sleep is a common companion of itch and is often reported by patients with chronic itch. Poor sleep is often characterized by nightly awakenings and troubles falling asleep. This is a significant problem as poor sleep in general is associated with lowered quality of life. While previous research has already established the negative impact of itch on sleep, it is yet to be studied whether the opposite tendency might be true as well. Knowledge about patients with chronic pain has shown that poor sleep can increase the sensitivity to pain and inflammation, and this tendency can also be observed in healthy participants after experimental sleep provocations.
Therefore, the investigators wish to investigate how sleep provocations affect markers of itch in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Participant will be blinded about application of pruritogens.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women
- •18-60 years
- •Speak and understand English
- •Access to a smartphone during the experimental nights
排除标准
- •Pregnancy or lactation
- •Drug addiction defined as any use of cannabis, opioids, or other drugs
- •Previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses (psychiatric diagnosis) that may affect the results (e.g., neuropathy, muscular pain in the upper extremities, anxiety, depression, schizophrenia etc.)
- •Moles, wounds, scars, or tattoos in the area to be treated or tested
- •Current use of medications that may affect the trial such as antihistamines and pain killers.
- •Skin diseases
- •Consumption of alcohol or painkillers 24 hours before the study days and between these
- •Acute or chronic pain and itch
- •Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical studies)
- •Lack of ability to cooperate
结局指标
主要结局
Assessment of itch
时间窗: Day 2: 1 minute after every itch inductions
Immediately following the itch provocations, participants will be instructed to rate the itch intensity for 10 minutes using a digital visual analogue scale (VAS; eVAS Software: Aalborg, University, Denmark), on a tablet. The scale will be measured from 0 to 100, where 0 represents 'no itch' and 100 'worst itch imaginable'.
Assessment of pain
时间窗: Day 2: 1 minute after every itch inductions
Immediately following the itch provocations, participants will be instructed to rate the pain intensity for 10 minutes using a digital visual analogue scale (VAS; eVAS Software: Aalborg, University, Denmark), on a tablet. The scale will be measured from 0 to 100, where 0 represents 'no pain' and 100 'worst pain imaginable'.
次要结局
- Microvascular reactivity(Day 2: 10 minutes after every itch inductions)
- Cold Detection Thresholds (CDT) and heat (HPT) pain thresholds(Day 2: 10 minutes after every itch inductions)
- Pain to Supra-threshold Heat Stimuli (STHS)(Day 2: 10 minutes after every itch inductions)
- Pressure Detection and Tolerance Threshold(Day 2: 10 minutes after every itch inductions)
- Conditioned Pain Modulation - CPM(Day 2: 10 minutes after every itch inductions)
- Mechanically evoked itch (MEI), intensity approach(Day 2: 10 minutes after every itch inductions)
- Deep-tissue Pain Sensitivity Measurements(Day 2: 10 minutes after every itch inductions)
- The Itch Catastrophizing Scale(Day 2)
- Touch Pleasantness (TP)(Day 2: 10 minutes after every itch inductions)
- Mechanical Pain Thresholds (MPT)(Day 2: 10 minutes after every itch inductions)
- Mechanical Pain Sensitivity (MPS), intensity approach(Day 2: 10 minutes after every itch inductions)
- Cold Detection Thresholds (CDT) and heat (HPT) detection(Day 2: 10 minutes after every itch inductions)
- Temporal Summation of Pain - TSP(Day 2: 10 minutes after every itch inductions)
- Positive and Negative Affective Schedule(Day 2)
- Mechanically evoked itch, spatial approach(Day 2: 10 minutes after every itch inductions)
- The Pittsburg Sleep Quality Index (PSQI)(Day 2)
- The Hospital Anxiety and Depression Scale (HADS)(Day 2)
- Blood Sampling for C-Reactive Protein Analysis(Day 2)
研究者
Silvia Lo Vecchio
Assistant Professor
Aalborg University