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

NCT06081946 | Recruiting DMC

• 1 other identifier: N-20230028
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Histamine; Cowhage; Sleep Fragmentation

Outcome Measures

Primary Outcomes (4)

• Assessment of itch

  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'.

  Day 1: 1 minute after every itch inductions

• Assessment of itch

  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'.

  Day 2: 1 minute after every itch inductions

• Assessment of pain

  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'.

  Day 1: 1 minute after every itch inductions

• Assessment of pain

  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'.

  Day 2: 1 minute after every itch inductions

Secondary Outcomes (36)

• Microvascular reactivity

  Day 1: 10 minutes after every itch inductions

• Microvascular reactivity

  Day 2: 10 minutes after every itch inductions

• Touch Pleasantness (TP)

  Day 1: 10 minutes after every itch inductions

• Touch Pleasantness (TP)

  Day 2: 10 minutes after every itch inductions

• Mechanically evoked itch (MEI), intensity approach

  Day 1: 10 minutes after every itch inductions

Study Arms (1)

Sleep fragmentation

EXPERIMENTAL

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.

Other: Histamine; Other: Cowhage

Interventions

Histamine 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

Sleep fragmentation

Cowhage 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

Sleep fragmentation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Aalborg University

Aalborg, 9620, Denmark

RECRUITING

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Histamine

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Ethylamines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

Silvia Kjær-Staal Lo Vecchio

CONTACT

+4521397785; slv@hst.aau.dk

Silvia Lo Vecchio

CONTACT

+4521397785; slv@hst.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Participant will be blinded about application of pruritogens.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The participants will be instructed to wake up at three designated timepoints for three consecutive nights at home.

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 13, 2023
• Study Start: December 15, 2023
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)