Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06081998
Other study ID # N-20230028 2nd Experiment
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date December 31, 2026

Study information

Verified date December 2023
Source Aalborg University
Contact kristian KS Petersen
Phone 31697510
Email KKP@hst.aau.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2026
Est. primary completion date December 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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
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

Locations

Country Name City State
Denmark Aalborg University Aalborg

Sponsors (1)

Lead Sponsor Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 Microvascular reactivity Microvascular reactivity The evoked cutaneous inflammation (quantified by superficial blood perfusion) will be measured by full-field laser perfusion imaging Day 1: 10 minutes after every itch inductions
Secondary Microvascular reactivity Microvascular reactivity The evoked cutaneous inflammation (quantified by superficial blood perfusion) will be measured by full-field laser perfusion imaging Day 2: 10 minutes after every itch inductions
Secondary 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. Day 1: 10 minutes after every itch inductions
Secondary 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. Day 2: 10 minutes after every itch inductions
Secondary 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. The subjects will report a score on a NRS scale ranging 0-10. Day 1: 10 minutes after every itch inductions
Secondary 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. The subjects will report a score on a NRS scale ranging 0-10. Day 2: 10 minutes after every itch inductions
Secondary 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). The subjects will report a score on a NRS scale ranging 0-10. Day 1: 10 minutes after every itch inductions
Secondary 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). The subjects will report a score on a NRS scale ranging 0-10. Day 2: 10 minutes after every itch inductions
Secondary 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. The subjects will report a score on a NRS scale ranging 0-10. Day 1: 10 minutes after every itch inductions
Secondary 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. The subjects will report a score on a NRS scale ranging 0-10. Day 2: 10 minutes after every itch inductions
Secondary 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'') on a NRS. Day 1: 10 minutes after every itch inductions
Secondary 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'') on a NRS. Day 2: 10 minutes after every itch inductions
Secondary 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 Day 1: 10 minutes after every itch inductions
Secondary 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 Day 2: 10 minutes after every itch inductions
Secondary 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 Day 1: 10 minutes after every itch inductions
Secondary 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 Day 2: 10 minutes after every itch inductions
Secondary 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). Day 1: 10 minutes after every itch inductions
Secondary 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). Day 2: 10 minutes after every itch inductions
Secondary 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. Day 1: 10 minutes after every itch inductions
Secondary 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. Day 2: 10 minutes after every itch inductions
Secondary 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. Day 1: 10 minutes after every itch inductions
Secondary 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. Day 2: 10 minutes after every itch inductions
Secondary 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. Day 1: 10 minutes after every itch inductions
Secondary 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. Day 2: 10 minutes after every itch inductions
Secondary 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
- Page 4 of 6 [DRAFT] - 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").
Day 1: 10 minutes after every itch inductions
Secondary 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
- Page 4 of 6 [DRAFT] - 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").
Day 2: 10 minutes after every itch inductions
Secondary 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 Day 1
Secondary 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 Day 2
Secondary 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. Day 1
Secondary 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. Day 2
Secondary The Hospital Anxiety and Depression Scale (HADS) The HADS consists of 14 items with two 7-item subscales measuring anxiety and depression symptoms, respectively Day 1
Secondary The Hospital Anxiety and Depression Scale (HADS) The HADS consists of 14 items with two 7-item subscales measuring anxiety and depression symptoms, respectively Day 2
Secondary 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 Day 1
Secondary 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 Day 2
Secondary Blood Sampling for C-Reactive Protein Analysis Whole blood samples will be collected from the antecubital vein using a vacutainer blood collection device (SMonovette, Sarstedt) with a 21-gauge needle. Day 1
Secondary Blood Sampling for C-Reactive Protein Analysis Whole blood samples will be collected from the antecubital vein using a vacutainer blood collection device (SMonovette, Sarstedt) with a 21-gauge needle. Day 2
See also
  Status Clinical Trial Phase
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT02996864 - Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II N/A
Completed NCT03129204 - Sensation Awareness Focused Training for Spouses N/A
Withdrawn NCT04049682 - Start Times and Restful Sleep
Completed NCT03182413 - Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation Phase 1
Not yet recruiting NCT01930279 - Effect of Partial Sleep Deprivation on Immunological System in Peripheral Blood N/A
Completed NCT01989741 - Effect of Sleep Restriction on Decision Making and Inflammation N/A
Completed NCT00228215 - Tips for Infant and Parent Sleep (TIPS) N/A
Completed NCT00123214 - A Change in Diet May Decrease the Negative Consequences of Chronic Sleep Deprivation N/A
Completed NCT00079664 - Comparing Tai Chi Training to a Low-Stress Physical Activity to Enhance Sleep in Older Adults Phase 1
Completed NCT04179838 - Olfactory Contributions to Sleep-dependent Food Craving N/A
Not yet recruiting NCT05513339 - Effect of Sleep Deprivation on Cognitive Function Among Cardiology Fellows
Recruiting NCT05026541 - Resilience to Sleep Deprivation and Changes in Sleep Architecture in Shoonya Meditators N/A
Withdrawn NCT04096261 - The Importance of Sleep Quality and the Blood-brain Barrier in Cognitive Disorders and Alzheimer's Disease
Recruiting NCT06017882 - Combined Effects of Acute Sleep Restriction and Moderate Acceleration (+Gz) on Physiological and Behavioral Responses to High Mental Workload
Completed NCT00179322 - Effects of Sleep Deprivation and Recovery on Cognitive Functions
Recruiting NCT06399939 - The Function of Biphasic Sleep in Infants N/A
Not yet recruiting NCT06027047 - Breakthrough Anxiety and Sleep Evaluation Using Linked Devices and Smartphone Application Onar (BASEL)
Completed NCT05162105 - Quick Returns - Sleep, Cognitive Functions and Individual Differences N/A
Completed NCT03981770 - Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Thyroid Surgery