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

NCT ID: NCT06081998

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-12-31

Brief Summary

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In This experiment, the investigators would like to test following hypotheses regarding the influence of sleep deprivation 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. 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 deprivation.

Detailed Description

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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

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Histamine Cowhage Sleep Deprivation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The participants will be instructed to stay awake for 24 hours following the baseline session of this subproject.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Participant will be blinded about application of pruritogens.

Study Groups

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Sleep deprivation

This subproject will be conducted in two sessions separated by three nights of sleep deprivation. 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

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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

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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

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Aalborg University

OTHER

Sponsor Role lead

Responsible Party

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Silvia Lo Vecchio

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aalborg University

Aalborg, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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kristian KS Petersen

Role: CONTACT

Phone: 31697510

Email: [email protected]

Silvia Lo Vecchio

Role: CONTACT

Phone: +4521397785

Email: [email protected]

Facility Contacts

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Silvia Lo Vecchio

Role: primary

Other Identifiers

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N-20230028 2nd Experiment

Identifier Type: -

Identifier Source: org_study_id