Clinical trial NCT06081946: Investigation of the Effects of Sleep Fragmentation on Itch and Pain Sensitivity
Official title: Investigation of the Effects of Sleep Provocations on Itch and Pain Sensitivity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Histamine
Cowhage
Sleep Fragmentation
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The participants will be instructed to wake up at three designated timepoints for three consecutive nights at home.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of itch
timeFrame: Day 1: 1 minute after every itch inductions
measure: Assessment of itch
timeFrame: Day 2: 1 minute after every itch inductions
measure: Assessment of pain
timeFrame: Day 1: 1 minute after every itch inductions
measure: Assessment of pain
timeFrame: Day 2: 1 minute after every itch inductions
Secondary outcomes:
measure: Microvascular reactivity
timeFrame: Day 1: 10 minutes after every itch inductions
measure: Microvascular reactivity
timeFrame: Day 2: 10 minutes after every itch inductions
measure: Touch Pleasantness (TP)
timeFrame: Day 1: 10 minutes after every itch inductions
measure: Touch Pleasantness (TP)
timeFrame: Day 2: 10 minutes after every itch inductions
measure: Mechanically evoked itch (MEI), intensity approach
timeFrame: Day 1: 10 minutes after every itch inductions
measure: Mechanically evoked itch (MEI), intensity approach
timeFrame: Day 2: 10 minutes after every itch inductions
measure: Mechanically evoked itch, spatial approach
timeFrame: Day 1: 10 minutes after every itch inductions
measure: Mechanically evoked itch, spatial approach
timeFrame: Day 2: 10 minutes after every itch inductions
measure: Mechanical Pain Thresholds (MPT)
timeFrame: Day 1: 10 minutes after every itch inductions
measure: Mechanical Pain Thresholds (MPT)
timeFrame: Day 2: 10 minutes after every itch inductions
measure: Mechanical Pain Sensitivity (MPS), intensity approach
timeFrame: Day 1: 10 minutes after every itch inductions
measure: Mechanical Pain Sensitivity (MPS), intensity approach
timeFrame: Day 2: 10 minutes after every itch inductions
measure: Cold Detection Thresholds (CDT) and heat (HPT) detection
timeFrame: Day 1: 10 minutes after every itch inductions
measure: Cold Detection Thresholds (CDT) and heat (HPT) detection
timeFrame: Day 2: 10 minutes after every itch inductions
measure: Cold Detection Thresholds (CDT) and heat (HPT) pain thresholds
timeFrame: Day 1: 10 minutes after every itch inductions
measure: Cold Detection Thresholds (CDT) and heat (HPT) pain thresholds
timeFrame: Day 2: 10 minutes after every itch inductions
measure: Pain to Supra-threshold Heat Stimuli (STHS)
timeFrame: Day 1: 10 minutes after every itch inductions
measure: Pain to Supra-threshold Heat Stimuli (STHS)
timeFrame: Day 2: 10 minutes after every itch inductions
measure: Deep-tissue Pain Sensitivity Measurements
timeFrame: Day 1: 10 minutes after every itch inductions
measure: Deep-tissue Pain Sensitivity Measurements
timeFrame: Day 2: 10 minutes after every itch inductions
measure: Pressure Detection and Tolerance Threshold
timeFrame: Day 1: 10 minutes after every itch inductions
measure: Pressure Detection and Tolerance Threshold
timeFrame: Day 2: 10 minutes after every itch inductions
measure: Temporal Summation of Pain - TSP
timeFrame: Day 1: 10 minutes after every itch inductions
measure: Temporal Summation of Pain - TSP
timeFrame: Day 2: 10 minutes after every itch inductions
measure: Conditioned Pain Modulation - CPM
timeFrame: Day 1: 10 minutes after every itch inductions
measure: Conditioned Pain Modulation - CPM
timeFrame: Day 2: 10 minutes after every itch inductions
measure: The Itch Catastrophizing Scale
timeFrame: Day 1
measure: The Itch Catastrophizing Scale
timeFrame: Day 2
measure: The Pittsburg Sleep Quality Index (PSQI)
timeFrame: Day 1
measure: The Pittsburg Sleep Quality Index (PSQI)
timeFrame: Day 2
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: Day 1
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: Day 2
measure: Positive and Negative Affective Schedule
timeFrame: Day 1
measure: Positive and Negative Affective Schedule
timeFrame: Day 2
measure: Blood Sampling for C-Reactive Protein Analysis
timeFrame: Day 1
measure: Blood Sampling for C-Reactive Protein Analysis
timeFrame: Day 2
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
Study officials:
References: