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

NCT ID: NCT06081946

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-15
• Study Completion Date: 2026-12-31

Brief 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

Histamine; Cowhage; Sleep Fragmentation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Sleep fragmentation

This subproject will be conducted in two sessions separated by three nights of sleep fragmentation. Each session will last approximately 2 hours. At the beginning of the first visit and after the last visit, 9 ml of blood will be drawn, and plasma will be isolated. After plasma isolation, the CRP concentration will be analyzed. In each forearm of the participant, a 4x4 cm area will be selected as Area of Interest (AOI). In these selected areas, itch will be induced in both sessions using histamine and cowhage and several tests will be conducted.

Group Type: EXPERIMENTAL

Histamine

Intervention Type: OTHER

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

Cowhage

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Silvia Lo Vecchio

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aalborg University

Aalborg, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Silvia Kjær-Staal Lo Vecchio

Role: CONTACT

slv@hst.aau.dk

+4521397785

Silvia Lo Vecchio

Role: CONTACT

slv@hst.aau.dk

+4521397785

Facility Contacts

Silvia Lo Vecchio

Role: primary

slv@hst.aau.dk

+4521397785

Other Identifiers

N-20230028

Identifier Type: -

Identifier Source: org_study_id