HistamineNCT06081946
Investigation of the Effects of Sleep Fragmentation on Itch and Pain Sensitivity
A study testing Histamine and Cowhage in people with Histamine and Cowhage, run by Aalborg University at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Histamine, Cowhage, Sleep Fragmentation
- What is being tested?
- Histamine and Cowhage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Dec 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- 18-60 years
- Speak and understand English
- Access to a smartphone during the experimental nights
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University
Aalborg, 9620
Silvia Lo Vecchio, +4521397785, slv@hst.aau.dk
About this study
Official title: Investigation of the Effects of Sleep Provocations on Itch and Pain Sensitivity
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.
Read the 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
- Being tested
- Histamine, Cowhage
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HistamineOther
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
CowhageOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Histamine; Other: Cowhage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: Day 2: 1 minute after every itch inductions
Secondary outcomes (36)
Microvascular reactivity
The evoked cutaneous inflammation (quantified by superficial blood perfusion) will be measured by full-field laser perfusion imaging.
Measured: Day 1: 10 minutes after every itch inductions
Microvascular reactivity
The evoked cutaneous inflammation (quantified by superficial blood perfusion) will be measured by full-field laser perfusion imaging.
Measured: Day 2: 10 minutes after every itch inductions
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.
Measured: Day 1: 10 minutes after every itch inductions
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.
Measured: Day 2: 10 minutes after every itch inductions
Mechanically evoked itch (MEI), intensity approach
MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force). This stimulator is moved in intervals of 0.5 cm outside the area of itch provocation.
Measured: Day 1: 10 minutes after every itch inductions
Mechanically evoked itch (MEI), intensity approach
MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force). This stimulator is moved in intervals of 0.5 cm outside the area of itch provocation.
Measured: Day 2: 10 minutes after every itch inductions
Mechanically evoked itch, spatial approach
The von-Frey filament that better evokes the itch sensation during the assessment of mechanically evoked itch as well as a template of soft plastic are used to map the area of hyperkinesis in the test areas (forearms)
Measured: Day 1: 10 minutes after every itch inductions
Mechanically evoked itch, spatial approach
The von-Frey filament that better evokes the itch sensation during the assessment of mechanically evoked itch as well as a template of soft plastic are used to map the area of hyperkinesis in the test areas (forearms)
Measured: Day 2: 10 minutes after every itch inductions
Mechanical Pain Thresholds (MPT)
This test is conducted using a pinprick set (Aalborg University, Aalborg). The set consists of 7 needles each with a diameter of 0.6 mm and different force applications: 8, 16, 32, 64, 128, 256, and 512 mN.
Measured: Day 1: 10 minutes after every itch inductions
Mechanical Pain Thresholds (MPT)
This test is conducted using a pinprick set (Aalborg University, Aalborg). The set consists of 7 needles each with a diameter of 0.6 mm and different force applications: 8, 16, 32, 64, 128, 256, and 512 mN.
Measured: Day 2: 10 minutes after every itch inductions
Mechanical Pain Sensitivity (MPS), intensity approach
This test is conducted with the same pinprick set used to test the MPT. Starting with the lightest, each stimulator is applied at a rate of 2 s on, 2 s off in an ascending order, and the subject will be asked to give a pain rating for each stimulus on a scale from 0-10 (where 0 indicates ''no pain'', and 10 indicates the ''worst imaginable pain'').
Measured: Day 1: 10 minutes after every itch inductions
Mechanical Pain Sensitivity (MPS), intensity approach
This test is conducted with the same pinprick set used to test the MPT. Starting with the lightest, each stimulator is applied at a rate of 2 s on, 2 s off in an ascending order, and the subject will be asked to give a pain rating for each stimulus on a scale from 0-10 (where 0 indicates ''no pain'', and 10 indicates the ''worst imaginable pain'').
Measured: Day 2: 10 minutes after every itch inductions
Cold Detection Thresholds (CDT) and heat (HPT) detection
Thermal cold and heat stimuli will be applied by a contact heat-evoked potential stimulator (PATHWAYS; Medoc Ltd, Ramat Yishai, Israel), placed 5 cm distal to the elbow on the right dorsal forearm
Measured: Day 1: 10 minutes after every itch inductions
Cold Detection Thresholds (CDT) and heat (HPT) detection
Thermal cold and heat stimuli will be applied by a contact heat-evoked potential stimulator (PATHWAYS; Medoc Ltd, Ramat Yishai, Israel), placed 5 cm distal to the elbow on the right dorsal forearm
Measured: Day 2: 10 minutes after every itch inductions
Cold Detection Thresholds (CDT) and heat (HPT) pain thresholds
Thermal cold and heat stimuli will be applied by a contact heat-evoked potential stimulator (PATHWAYS; Medoc Ltd, Ramat Yishai, Israel), placed 5 cm distal to the elbow on the right dorsal forearm
Measured: Day 1: 10 minutes after every itch inductions
Cold Detection Thresholds (CDT) and heat (HPT) pain thresholds
Thermal cold and heat stimuli will be applied by a contact heat-evoked potential stimulator (PATHWAYS; Medoc Ltd, Ramat Yishai, Israel), placed 5 cm distal to the elbow on the right dorsal forearm
Measured: Day 2: 10 minutes after every itch inductions
Pain to Supra-threshold Heat Stimuli (STHS)
The tests will be conducted by using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device. A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape. The subjects will rate the pain to three suprathreshold heat pain stimuli (starting and ending at 32°C with an increase and decrease of 5°C and 3 s plateau at 50°C).
Measured: Day 1: 10 minutes after every itch inductions
Pain to Supra-threshold Heat Stimuli (STHS)
The tests will be conducted by using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device. A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape. The subjects will rate the pain to three suprathreshold heat pain stimuli (starting and ending at 32°C with an increase and decrease of 5°C and 3 s plateau at 50°C).
Measured: Day 2: 10 minutes after every itch inductions
Deep-tissue Pain Sensitivity Measurements
Deep-tissue pain sensitivity will be evaluated by cuff pressure stimuli using a computer-controlled cuff algometer (Cortex Technology and Aalborg University, Denmark) including a 13-cm wide tourniquet cuff (VBM, Sulz, Germany) and an electronic visual analog scale (VAS) (Aalborg University, Denmark) for recording of the pain intensity.
Measured: Day 1: 10 minutes after every itch inductions
Deep-tissue Pain Sensitivity Measurements
Deep-tissue pain sensitivity will be evaluated by cuff pressure stimuli using a computer-controlled cuff algometer (Cortex Technology and Aalborg University, Denmark) including a 13-cm wide tourniquet cuff (VBM, Sulz, Germany) and an electronic visual analog scale (VAS) (Aalborg University, Denmark) for recording of the pain intensity.
Measured: Day 2: 10 minutes after every itch inductions
Pressure Detection and Tolerance Threshold
The pressure will be increased by 1 kPa/s and the subject will be instructed to rate the pain intensity continuously on the electronic VAS until the tolerance level is reached.
Measured: Day 1: 10 minutes after every itch inductions
Pressure Detection and Tolerance Threshold
The pressure will be increased by 1 kPa/s and the subject will be instructed to rate the pain intensity continuously on the electronic VAS until the tolerance level is reached.
Measured: Day 2: 10 minutes after every itch inductions
Temporal Summation of Pain - TSP
A total of 10 repeated mechanical pressure stimuli at the PTT level will be delivered at 0.5 Hz (1 s stimulus duration and 1 s interval between stimuli) to the lower leg. A constant pressure of 5 kPa will be applied between the individual pressure stimuli to avoid movement of the cuff. During the 10 repeated stimuli, the subject will continuously rate the pain intensity on a 10 cm continuous VAS.
Measured: Day 1: 10 minutes after every itch inductions
Temporal Summation of Pain - TSP
A total of 10 repeated mechanical pressure stimuli at the PTT level will be delivered at 0.5 Hz (1 s stimulus duration and 1 s interval between stimuli) to the lower leg. A constant pressure of 5 kPa will be applied between the individual pressure stimuli to avoid movement of the cuff. During the 10 repeated stimuli, the subject will continuously rate the pain intensity on a 10 cm continuous VAS.
Measured: Day 2: 10 minutes after every itch inductions
Conditioned Pain Modulation - CPM
The concept of CPM is that a tonic painful stimulus (conditioning stimulus) will inhibit pain evoked simultaneously from another site (test stimulus). The painful conditioned stimulus will be applied simultaneously with the assessment stimulus. The conditioned stimulus will be terminated right after the subject presses the stop button. CPM will be defined as the difference between stimulus during and before the conditioned pain (i.e., "during" minus "before").
Measured: Day 1: 10 minutes after every itch inductions
Conditioned Pain Modulation - CPM
The concept of CPM is that a tonic painful stimulus (conditioning stimulus) will inhibit pain evoked simultaneously from another site (test stimulus). The painful conditioned stimulus will be applied simultaneously with the assessment stimulus. The conditioned stimulus will be terminated right after the subject presses the stop button. CPM will be defined as the difference between stimulus during and before the conditioned pain (i.e., "during" minus "before").
Measured: Day 2: 10 minutes after every itch inductions
The Itch Catastrophizing Scale
The itch catastrophizing scale is a modified version of the pain catastrophizing scale (PCS), which is a validated questionnaire measuring pain-related thoughts and feelings. The questionnaire consists of 13 items measuring itch-related thoughts and feelings. Each item is rated on a 4-point scale ranging from zero to four, corresponding to thinking/feeling that way during itch 'not at all' and 'very much', respectively.
Measured: Day 1
The Itch Catastrophizing Scale
The itch catastrophizing scale is a modified version of the pain catastrophizing scale (PCS), which is a validated questionnaire measuring pain-related thoughts and feelings. The questionnaire consists of 13 items measuring itch-related thoughts and feelings. Each item is rated on a 4-point scale ranging from zero to four, corresponding to thinking/feeling that way during itch 'not at all' and 'very much', respectively.
Measured: Day 2
The Pittsburg Sleep Quality Index (PSQI)
The PSQI consists of 19 items generating seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The seven component scores can be summarized in a global score ranging from zero to 21 with higher scores reflecting a worse overall quality of sleep.
Measured: Day 1
The Pittsburg Sleep Quality Index (PSQI)
The PSQI consists of 19 items generating seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The seven component scores can be summarized in a global score ranging from zero to 21 with higher scores reflecting a worse overall quality of sleep.
Measured: Day 2
The Hospital Anxiety and Depression Scale (HADS)
The HADS consists of 14 items with two 7-item subscales measuring anxiety and depression symptoms, respectively. Each item is scored on a 4-point scale with zero to three with each subscale ranging from zero to 21. Within both subscales, the scoring is grouped into either normal (0-7), borderline abnormal (8-10), and abnormal (11-21).
Measured: Day 1
The Hospital Anxiety and Depression Scale (HADS)
The HADS consists of 14 items with two 7-item subscales measuring anxiety and depression symptoms, respectively. Each item is scored on a 4-point scale with zero to three with each subscale ranging from zero to 21. Within both subscales, the scoring is grouped into either normal (0-7), borderline abnormal (8-10), and abnormal (11-21).
Measured: Day 2
Positive and Negative Affective Schedule
This 20-item instrument is a psychometric self-report test to assess affect (10 items for positive affect and 10 items for negative affect) and validated for the use in adolescents and adults.
Measured: Day 1
Positive and Negative Affective Schedule
This 20-item instrument is a psychometric self-report test to assess affect (10 items for positive affect and 10 items for negative affect) and validated for the use in adolescents and adults.
Measured: Day 2
Blood Sampling for C-Reactive Protein Analysis
Whole blood samples will be collected from the antecubital vein using a vacutainer blood collection device (S-Monovette, Sarstedt) with a 21-gauge needle.
Measured: Day 1
Blood Sampling for C-Reactive Protein Analysis
Whole blood samples will be collected from the antecubital vein using a vacutainer blood collection device (S-Monovette, Sarstedt) with a 21-gauge needle.
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start15 Dec 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HistamineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The participants will be instructed to wake up at three designated timepoints for three consecutive nights at home.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Lo Vecchio, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081946
- Sponsor's protocol ID
- N-20230028
- Status last verified
- Nov 2024
- First submitted
- 2 Oct 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Sleep Provocations on Itch and Pain Sensitivity
- ClinicalTrials.gov ID
- NCT06081946
- Acronym / sponsor ID
- N-20230028
- Conditions
- Histamine, Cowhage, Sleep Fragmentation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The participants will be instructed to wake up at three designated timepoints for three consecutive nights at home.
| Arm | Type | Receives |
|---|---|---|
| Sleep fragmentation | Experimental | Other: Histamine, Other: CowhageThis 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy men and women
- 18-60 years
- Speak and understand English
- Access to a smartphone during the experimental nights
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HistamineHistaminergic 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 | Other | Sleep fragmentation |
| Cowhage25 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 | Other | Sleep fragmentation |
Primary outcome
Assessment of itch
Time frame: Day 1: 1 minute after every itch inductions
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'.
Assessment of itch
Time frame: Day 2: 1 minute after every itch inductions
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'.
Assessment of pain
Time frame: Day 1: 1 minute after every itch inductions
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'.
Assessment of pain
Time frame: Day 2: 1 minute after every itch inductions
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'.
36 secondary outcomes
Microvascular reactivity
Time frame: Day 1: 10 minutes after every itch inductions
Microvascular reactivity
Time frame: Day 2: 10 minutes after every itch inductions
Touch Pleasantness (TP)
Time frame: Day 1: 10 minutes after every itch inductions
Touch Pleasantness (TP)
Time frame: Day 2: 10 minutes after every itch inductions
Mechanically evoked itch (MEI), intensity approach
Time frame: Day 1: 10 minutes after every itch inductions
Mechanically evoked itch (MEI), intensity approach
Time frame: Day 2: 10 minutes after every itch inductions
Mechanically evoked itch, spatial approach
Time frame: Day 1: 10 minutes after every itch inductions
Mechanically evoked itch, spatial approach
Time frame: Day 2: 10 minutes after every itch inductions
Mechanical Pain Thresholds (MPT)
Time frame: Day 1: 10 minutes after every itch inductions
Mechanical Pain Thresholds (MPT)
Time frame: Day 2: 10 minutes after every itch inductions
Mechanical Pain Sensitivity (MPS), intensity approach
Time frame: Day 1: 10 minutes after every itch inductions
Mechanical Pain Sensitivity (MPS), intensity approach
Time frame: Day 2: 10 minutes after every itch inductions
Cold Detection Thresholds (CDT) and heat (HPT) detection
Time frame: Day 1: 10 minutes after every itch inductions
Cold Detection Thresholds (CDT) and heat (HPT) detection
Time frame: Day 2: 10 minutes after every itch inductions
Cold Detection Thresholds (CDT) and heat (HPT) pain thresholds
Time frame: Day 1: 10 minutes after every itch inductions
Cold Detection Thresholds (CDT) and heat (HPT) pain thresholds
Time frame: Day 2: 10 minutes after every itch inductions
Pain to Supra-threshold Heat Stimuli (STHS)
Time frame: Day 1: 10 minutes after every itch inductions
Pain to Supra-threshold Heat Stimuli (STHS)
Time frame: Day 2: 10 minutes after every itch inductions
Deep-tissue Pain Sensitivity Measurements
Time frame: Day 1: 10 minutes after every itch inductions
Deep-tissue Pain Sensitivity Measurements
Time frame: Day 2: 10 minutes after every itch inductions
Pressure Detection and Tolerance Threshold
Time frame: Day 1: 10 minutes after every itch inductions
Pressure Detection and Tolerance Threshold
Time frame: Day 2: 10 minutes after every itch inductions
Temporal Summation of Pain - TSP
Time frame: Day 1: 10 minutes after every itch inductions
Temporal Summation of Pain - TSP
Time frame: Day 2: 10 minutes after every itch inductions
Conditioned Pain Modulation - CPM
Time frame: Day 1: 10 minutes after every itch inductions
Conditioned Pain Modulation - CPM
Time frame: Day 2: 10 minutes after every itch inductions
The Itch Catastrophizing Scale
Time frame: Day 1
The Itch Catastrophizing Scale
Time frame: Day 2
The Pittsburg Sleep Quality Index (PSQI)
Time frame: Day 1
The Pittsburg Sleep Quality Index (PSQI)
Time frame: Day 2
The Hospital Anxiety and Depression Scale (HADS)
Time frame: Day 1
The Hospital Anxiety and Depression Scale (HADS)
Time frame: Day 2
Positive and Negative Affective Schedule
Time frame: Day 1
Positive and Negative Affective Schedule
Time frame: Day 2
Blood Sampling for C-Reactive Protein Analysis
Time frame: Day 1
Blood Sampling for C-Reactive Protein Analysis
Time frame: Day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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Chronic Spontaneous Urticaria (CSU), Chronic Idiopathic Urticaria
Enrolling by invitation
Personalized Probiotic Treatments for Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS)
Not yet recruiting
Radicle GI Health™ RFY: A Study Assessing the Impact of DAO Supplementation on Gastrointestinal and Other Histamine Intolerance Symptoms
GI Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Histamine and Cowhage in people with Histamine and Cowhage, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Kjær-Staal Lo Vecchio (+4521397785, slv@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of itch (time frame: Day 1: 1 minute after every itch inductions). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.