Investigation of the Effects of Sleep Fragmentation on Itch and Pain Sensitivity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAalborg University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy men and women
18-60 years
Speak and understand English
Access to a smartphone during the experimental nights
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Histamine
Other interventionHistaminergic 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
Other intervention25 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
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Sleep fragmentationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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'.
Time frame
Day 1: 1 minute after every itch inductions2
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'.
Time frame
Day 2: 1 minute after every itch inductions3
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'.
Time frame
Day 1: 1 minute after every itch inductions4
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'.
Time frame
Day 2: 1 minute after every itch inductionsSecondary outcomes
1
Microvascular reactivity
The evoked cutaneous inflammation (quantified by superficial blood perfusion) will be measured by full-field laser perfusion imaging.
Time frame
Day 1: 10 minutes after every itch inductions2
Microvascular reactivity
The evoked cutaneous inflammation (quantified by superficial blood perfusion) will be measured by full-field laser perfusion imaging.
Time frame
Day 2: 10 minutes after every itch inductions3
Touch Pleasantness (TP)
Pleasant touch sensation measured using a standardized sensory brush (SENSELab Brush-05, Somedic AB, Hörby, Sweden) exerting a force of 200 to 400 mN. The stimulation consists of three strokes (2 cm in length) over the treated/control areas. The strokes will be applied perpendicularly to the skin and the subject will rate the sensation induced by the brush on a NRS scale labeled "very unpleasant" and "very pleasant" at the extremity and "neutral" at the center.
Time frame
Day 1: 10 minutes after every itch inductions4
Touch Pleasantness (TP)
Pleasant touch sensation measured using a standardized sensory brush (SENSELab Brush-05, Somedic AB, Hörby, Sweden) exerting a force of 200 to 400 mN. The stimulation consists of three strokes (2 cm in length) over the treated/control areas. The strokes will be applied perpendicularly to the skin and the subject will rate the sensation induced by the brush on a NRS scale labeled "very unpleasant" and "very pleasant" at the extremity and "neutral" at the center.
Time frame
Day 2: 10 minutes after every itch inductionsSponsors and contacts
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Source ClinicalTrials.gov