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RecruitingNCT06081946

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

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Aalborg University · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERHistamineHistaminergic 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
OTHERCowhage25 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

Timeline

Start date
2023-12-15
Primary completion
2025-09-30
Completion
2026-12-31
First posted
2023-10-13
Last updated
2024-11-22

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT06081946. Inclusion in this directory is not an endorsement.