Investigation of the Effects of Sleep Fragmentation on Itch and Pain Sensitivity

Официальное название

Investigation of the Effects of Sleep Provocations on Itch and Pain Sensitivity

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Histamine
  Histaminergic itch will be evoked by a 1% histamine solution. A droplet of histamine solution will be placed on the predetermined area on the forearm, and the SPT lancet will be pierced through the histamine with 120 g of pressure for 1-2 seconds
• Другое Cowhage
  25 spicules will be inserted in the centre of the predefined skin area on the mandibular area. The spicules will be gently rubbed for 15-20 seconds in circular motion to facilitate epidermal penetration

Первичные конечные точки

• Assessment of itch [Срок оценки: Day 1: 1 minute after every itch inductions]
• Assessment of itch [Срок оценки: Day 2: 1 minute after every itch inductions]
• Assessment of pain [Срок оценки: Day 1: 1 minute after every itch inductions]
• Assessment of pain [Срок оценки: Day 2: 1 minute after every itch inductions]

Вторичные конечные точки (12)

• Microvascular reactivity [Срок оценки: Day 1: 10 minutes after every itch inductions]
• Microvascular reactivity [Срок оценки: Day 2: 10 minutes after every itch inductions]
• Touch Pleasantness (TP) [Срок оценки: Day 1: 10 minutes after every itch inductions]
• Touch Pleasantness (TP) [Срок оценки: Day 2: 10 minutes after every itch inductions]
• Mechanically evoked itch (MEI), intensity approach [Срок оценки: Day 1: 10 minutes after every itch inductions]
• Mechanically evoked itch (MEI), intensity approach [Срок оценки: Day 2: 10 minutes after every itch inductions]
• Mechanically evoked itch, spatial approach [Срок оценки: Day 1: 10 minutes after every itch inductions]
• Mechanically evoked itch, spatial approach [Срок оценки: Day 2: 10 minutes after every itch inductions]
• Mechanical Pain Thresholds (MPT) [Срок оценки: Day 1: 10 minutes after every itch inductions]
• Mechanical Pain Thresholds (MPT) [Срок оценки: Day 2: 10 minutes after every itch inductions]
• Mechanical Pain Sensitivity (MPS), intensity approach [Срок оценки: Day 1: 10 minutes after every itch inductions]
• Mechanical Pain Sensitivity (MPS), intensity approach [Срок оценки: Day 2: 10 minutes after every itch inductions]

Критерии участия

Критерии включения

• Healthy men and women
• 18-60 years
• Speak and understand English
• Access to a smartphone during the experimental nights

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Дания · 1 центр

• Aalborg University — Aalborg

Идентификаторы

NCT: NCT06081946 · N-20230028

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗