Sensitization, CentralNCT05494983
Pain, Sleep and Gut Microbiota
A study testing Screening visit, Peripheral sensitization session and Central sensitization session in people with Sensitization, Central and Peripheral Sensitization, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The objective of this study in healthy volunteers is to evaluate whether the composition of the gut microbiota and sleep quality influence the susceptibility to develop peripheral and central sensitization of pain pathways. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensitization, Central, Peripheral Sensitization, Gut Microbiota
- What is being tested?
- Screening visit, Peripheral sensitization session and Central sensitization session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Jul 2022to 4 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years
- Ability to provide written informed consent
- Understanding French
Who cannot join
- Current or recent (< 2 months) use of antibiotics, probiotics, fiber supplements or any other molecule that modifies intestinal transit.
- Current or recent (< 1 month) use of non-steroidal anti-inflammatory drugs and glucocorticoids
- Not willing or able to abstain from acute alcohol intoxication from 7 days prior to each of the two study sessions.
- Consumption of alcohol 24 hours prior to each of the two study sessions.
- Consumption of hypnotics, centrally-acting analgesics or psychotropic drugs.
- Obesity: body mass index > 30 kg.m-2
Show all 18Show fewer
- Pregnancy and breast-feeding
- Diabetes
- Cancer
- History of inflammatory bowel disease
- History of weight-loss surgery (e.g., gastric bypass, gastric band)
- History of autoimmune disease (e.g., lupus, rheumatoid arthritis)
- Evidence for any other clinically significant disease on direct questioning.
- Being a volleyball player due to risk of modified sensitivity of the volar forearm skin.
- Any implanted medical device such as cardiac pacemakers, cochlear implants and medication pumps.
- Dermatological condition affecting the skin of the volar forearms.
- History of an allergy to chili peppers/capsaicin.
- Any other reason to exclude the subject according to judgment by the investigator.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UCLouvain, IONS
Woluwe-Saint-Lambert, 1200
André Mouraux, MD, PhD, andre.mouraux@uclouvain.be
Gwenaëlle Mievis, PhD Student, gwenaelle.mievis@uclouvain.be
About this study
The objective of this study in healthy volunteers is to evaluate whether the composition of the gut microbiota and sleep quality influence the susceptibility to develop peripheral and central sensitization of pain pathways.
In two different experimental sessions, the following factors will be tested: the influence of the composition of the gut microbiota on the susceptibility to develop peripheral sensitization of nociceptors, and the susceptibility to develop central sensitization of pain pathways. To assess susceptibility to peripheral sensitization, a solution of capsaicin (the active component of chili pepper) will be applied to the skin to induce neurogenic inflammation produced by the release of substances from nociceptors at the peripheral level. This neurogenic inflammation is characterized by a transient redness of the skin that will be measured with an infrared camera. To evaluate the susceptibility to sensitization at the central level, a high frequency electrical stimulation will be applied to the skin. This stimulation induces an increase in sensitivity to mechanical stimulation secondary to central sensitization. The intensity, extent and duration of this mechanical hyperalgesia will therefore be used as a measure of susceptibility to central sensitization.
Read more
A stool sample and a blood sample will be taken. These samples will be used to characterize the composition of the intestinal microbiota, as well as the metabolites produced by this microbiota. These analyses will allow a comparison of the composition of the microbiota and the metabolites in subjects with a tendency to develop low vs. high sensitization at the peripheral and central levels.
Similarly, sleep quality and average sleep duration will be assessed using questionnaires and a measurement of the participant's activity using a wrist movement sensitive bracelet. This information will be used to assess whether some of the interindividual variability in developing peripheral or central sensitization might be related to differences in sleep quality.
Finally, systemic inflammation could be a factor modulated by sleep and gut microbiota, influencing pain perception and susceptibility to sensitization. For this reason, systemic pro- and anti-inflammatory cytokines will be measured in the blood sample.
- Being tested
- Screening visit, Peripheral sensitization session, Central sensitization session
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening visitOther
The participants will be screened for inclusion and exclusion criteria and will be asked to fill the following questionnaires : Pittsburgh Sleep Quality Index, State and Trait Anxiety Questionnaire, Pain Catastrophizing Scale Fear of Pain Questionnaire, Perceived Stress Scale, Beck Depression Inventory, and questionnaires to assess their health status and the use of medications. A blood sample (to measure pro- and anti-inflammatory cytokines and perform metabolomic analyses) will be obtained. Enrolled participants will be given a wearable actimeter to assess daily total sleep duration during one week before the first experimental session. They will also be requested to complete daily a sleep diary during one week before each experimental session, and a food diary before the first experimental session. A fecal sample (to assess gut microbiota composition and perform metabolomic analyses) will be collected between the screening visit and the first experimental session.
Peripheral sensitization sessionOther
The extent of neurogenic inflammation induced by topical capsaicin will be used as a measure of the susceptibility to sensitize at peripheral level. A solution of capsaicin will be applied to the skin of the left or right volar forearm for 30 minutes. The capsaicin-induced neurogenic inflammation can be quantified by assessing the intensity, extent and duration of the capsaicin-induced cutaneous flare response using thermal infrared imaging. Using heat stimuli delivered to the treated skin and surrounding skin, the intensity and duration of the capsaicin-induced hyperalgesia will also be assessed. The experimental session will last approximately two hours.
Central sensitization sessionOther
The extent of secondary mechanical hyperalgesia induced by high-frequency electrical stimulation (HFS) of the skin of the left or right volar forearm will be used as a measure of the susceptibility to develop central sensitization. The stimulation will be delivered using a multi-pin electrode designed to preferentially activate epidermal free nerve endings. The strength, spatial extent and duration of the HFS-induced changes in pinprick sensitivity will be characterized by using calibrated mechanical pinprick stimuli. The experimental session will last approximately one hour.
| Study group | Role | What they receive |
|---|---|---|
| Session 1 : Peripheral Session (left) - session 2 Central Session (right) | Other | The susceptibility to develop peripheral sensitization will be assessed at the first experimental session, the stimulation will occur at the left forearm.
The susceptibility to develop central sensitization will be assessed at the second experimental session, the stimulation will occur at the right forearm.
In both experimental sessions, participants will have to fill questionnaires about the use of medications, the Stanford Sleepiness Scale, the Leeds Sleep Evaluation Questionnaire, and the first part of the State and Trait Anxiety Questionnaire. During sensory stimulation, an infrared camera will be used to measure pupil diameter which constitute an indirect correlate of stimulus-evoked phasic variations in activity of the locus coeruleus. In order to measure autonomic reactivity to pain stimuli, the heart rate variability will be measured by recording electrocardiography. Receives: Other: Screening visit; Other: Peripheral sensitization session; Other: Central sensitization session |
| Session 1 : Peripheral Session (right) - session 2 Central Session (left) | Other | The susceptibility to develop peripheral sensitization will be assessed at the first experimental session, the stimulation will occur at the right forearm.
The susceptibility to develop central sensitization will be assessed at the second experimental session, the stimulation will occur at the left forearm.
In both experimental sessions, participants will have to fill questionnaires about the use of medications, the Stanford Sleepiness Scale, the Leeds Sleep Evaluation Questionnaire, and the first part of the State and Trait Anxiety Questionnaire. During sensory stimulation, an infrared camera will be used to measure pupil diameter which constitute an indirect correlate of stimulus-evoked phasic variations in activity of the locus coeruleus. In order to measure autonomic reactivity to pain stimuli, the heart rate variability will be measured by recording electrocardiography. Receives: Other: Screening visit; Other: Peripheral sensitization session; Other: Central sensitization session |
| Session 1 : Central Session (left) - session 2 Peripheral Session (right) | Other | The susceptibility to develop central sensitization will be assessed at the first experimental session, the stimulation will occur at the left forearm.
The susceptibility to develop peripheral sensitization will be assessed at the second experimental session, the stimulation will occur at the right forearm.
In both experimental sessions, participants will have to fill questionnaires about the use of medications, the Stanford Sleepiness Scale, the Leeds Sleep Evaluation Questionnaire, and the first part of the State and Trait Anxiety Questionnaire. During sensory stimulation, an infrared camera will be used to measure pupil diameter which constitute an indirect correlate of stimulus-evoked phasic variations in activity of the locus coeruleus. In order to measure autonomic reactivity to pain stimuli, the heart rate variability will be measured by recording electrocardiography. Receives: Other: Screening visit; Other: Peripheral sensitization session; Other: Central sensitization session |
| Session 1 : Central Session (right) - session 2 Peripheral Session (left) | Other | The susceptibility to develop central sensitization will be assessed at the first experimental session, the stimulation will occur at the right forearm.
The susceptibility to develop peripheral sensitization will be assessed at the second experimental session, the stimulation will occur at the left forearm.
In both experimental sessions, participants will have to fill questionnaires about the use of medications, the Stanford Sleepiness Scale, the Leeds Sleep Evaluation Questionnaire, and the first part of the State and Trait Anxiety Questionnaire. During sensory stimulation, an infrared camera will be used to measure pupil diameter which constitute an indirect correlate of stimulus-evoked phasic variations in activity of the locus coeruleus. In order to measure autonomic reactivity to pain stimuli, the heart rate variability will be measured by recording electrocardiography. Receives: Other: Screening visit; Other: Peripheral sensitization session; Other: Central sensitization session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between composition of the intestinal microbiota and its metabolites and the susceptibility of sensitization at the peripheral and central levels.
A stool sample and a blood sample will be taken. These samples will be used to characterize the composition of the intestinal microbiota, as well as the metabolites produced by this microbiota. These analyses will allow a comparison of the composition of the microbiota and the metabolites in subjects with a tendency to develop low vs. high sensitization at the peripheral and central levels.
The gut microbiota composition will be analyzed using 16S rDNA sequencing. Untargeted metabolite profiling, in fecal and blood samples, will be performed using liquid chromatography (LC) coupled with tandem mass spectrometry (MS-MS) platforms.
Measured: one week
Correlation between sleep quality and the susceptibility of sensitization at the peripheral and central levels.
Sleep quality will be assessed using questionnaires and a measurement of the participant's sleep using a wrist movement sensitive bracelet. This information will be used to assess whether some of the inter-individual variability in developing peripheral or central sensitization might be related to differences in sleep quality.
Measured: five weeks
Correlation between sleep duration and the susceptibility of sensitization at the peripheral and central levels.
Average sleep duration will be assessed using questionnaires and a measurement of the participant's sleep using a wrist movement sensitive bracelet. This information will be used to assess whether some of the inter-individual variability in developing peripheral or central sensitization might be related to differences in sleep duration.
Measured: five weeks
Secondary outcomes (3)
Correlation between levels of systemic pro- and anti-inflammatory cytokines measured by multiplex assays and the susceptibility of sensitization at the peripheral and central levels.
Systemic inflammation could be an important factor modulated by sleep and the gut microbiota, influencing nociception and sensitization at peripheral and central levels. Plasma concentrations (pg/mL) of several pro-inflammatory (TNFa, IL-6, IL-1b, MCP-1) and anti-inflammatory (IL-10) markers will me measured using commercially available multiplex assays.
Measured: one week
Correlation between pupil diameter and the susceptibility of sensitization at the peripheral and central levels.
During sensory stimulation, an infrared camera will be used to measure pupil diameter which has been shown to constitute an indirect correlate of stimulus-evoked phasic variations in activity of the locus coeruleus.
Measured: five weeks
Correlation between heart rate variability and the susceptibility of sensitization at the peripheral and central levels.
In order to measure autonomic reactivity to pain stimuli, the heart rate variability will be measured by recording electrocardiography during experimental sessions.
Measured: five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start4 Jul 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion4 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitization, CentralStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- André Mouraux, MD, PhD, Principal investigator, UCLouvain, IONS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494983
- Sponsor's protocol ID
- PAIN,SLEEP,MICROBIOTA
- Status last verified
- Jan 2024
- First submitted
- 22 Jun 2022
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain, Sleep and Gut Microbiota
- ClinicalTrials.gov ID
- NCT05494983
- Acronym / sponsor ID
- PAIN,SLEEP,MICROBIOTA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 4 Jan 2026 (estimated)
- First posted
- 10 Aug 2022 (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.
The objective of this study in healthy volunteers is to evaluate whether the composition of the gut microbiota and sleep quality influence the susceptibility to develop peripheral and central sensitization of pain pathways.
In two different experimental sessions, the following factors will be tested: the influence of the composition of the gut microbiota on the susceptibility to develop peripheral sensitization of nociceptors, and the susceptibility to develop central sensitization of pain pathways. To assess susceptibility to peripheral sensitization, a solution of capsaicin (the active component of chili pepper) will be applied to the skin to induce neurogenic inflammation produced by the release of substances from nociceptors at the peripheral level. This neurogenic inflammation is characterized by a transient redness of the skin that will be measured with an infrared camera. To evaluate the susceptibility to sensitization at the central level, a high frequency electrical stimulation will be applied to the skin. This stimulation induces an increase in sensitivity to mechanical stimulation secondary to central sensitization. The intensity, extent and duration of this mechanical hyperalgesia will therefore be used as a measure of susceptibility to central sensitization.
A stool sample and a blood sample will be taken. These samples will be used to characterize the composition of the intestinal microbiota, as well as the metabolites produced by this microbiota. These analyses will allow a comparison of the composition of the microbiota and the metabolites in subjects with a tendency to develop low vs. high sensitization at the peripheral and central levels.
Similarly, sleep quality and average sleep duration will be assessed using questionnaires and a measurement of the participant's activity using a wrist movement sensitive bracelet. This information will be used to assess whether some of the interindividual variability in developing peripheral or central sensitization might be related to differences in sleep quality.
Finally, systemic inflammation could be a factor modulated by sleep and gut microbiota, influencing pain perception and susceptibility to sensitization. For this reason, systemic pro- and anti-inflammatory cytokines will be measured in the blood sample.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Session 1 : Peripheral Session (left) - session 2 Central Session (right) | Other | Other: Screening visit, Other: Peripheral sensitization session, Other: Central sensitization sessionThe susceptibility to develop peripheral sensitization will be assessed at the first experimental session, the stimulation will occur at the left forearm. The susceptibility to develop central sensitization will be assessed at the second experimental session, the stimulation will occur at the right forearm. In both experimental sessions, participants will have to fill questionnaires about the use of medications, the Stanford Sleepiness Scale, the Leeds Sleep Evaluation Questionnaire, and the first part of the State and Trait Anxiety Questionnaire. During sensory stimulation, an infrared camera will be used to measure pupil diameter which constitute an indirect correlate of stimulus-evoked phasic variations in activity of the locus coeruleus. In order to measure autonomic reactivity to pain stimuli, the heart rate variability will be measured by recording electrocardiography. |
| Session 1 : Peripheral Session (right) - session 2 Central Session (left) | Other | Other: Screening visit, Other: Peripheral sensitization session, Other: Central sensitization sessionThe susceptibility to develop peripheral sensitization will be assessed at the first experimental session, the stimulation will occur at the right forearm. The susceptibility to develop central sensitization will be assessed at the second experimental session, the stimulation will occur at the left forearm. In both experimental sessions, participants will have to fill questionnaires about the use of medications, the Stanford Sleepiness Scale, the Leeds Sleep Evaluation Questionnaire, and the first part of the State and Trait Anxiety Questionnaire. During sensory stimulation, an infrared camera will be used to measure pupil diameter which constitute an indirect correlate of stimulus-evoked phasic variations in activity of the locus coeruleus. In order to measure autonomic reactivity to pain stimuli, the heart rate variability will be measured by recording electrocardiography. |
| Session 1 : Central Session (left) - session 2 Peripheral Session (right) | Other | Other: Screening visit, Other: Peripheral sensitization session, Other: Central sensitization sessionThe susceptibility to develop central sensitization will be assessed at the first experimental session, the stimulation will occur at the left forearm. The susceptibility to develop peripheral sensitization will be assessed at the second experimental session, the stimulation will occur at the right forearm. In both experimental sessions, participants will have to fill questionnaires about the use of medications, the Stanford Sleepiness Scale, the Leeds Sleep Evaluation Questionnaire, and the first part of the State and Trait Anxiety Questionnaire. During sensory stimulation, an infrared camera will be used to measure pupil diameter which constitute an indirect correlate of stimulus-evoked phasic variations in activity of the locus coeruleus. In order to measure autonomic reactivity to pain stimuli, the heart rate variability will be measured by recording electrocardiography. |
| Session 1 : Central Session (right) - session 2 Peripheral Session (left) | Other | Other: Screening visit, Other: Peripheral sensitization session, Other: Central sensitization sessionThe susceptibility to develop central sensitization will be assessed at the first experimental session, the stimulation will occur at the right forearm. The susceptibility to develop peripheral sensitization will be assessed at the second experimental session, the stimulation will occur at the left forearm. In both experimental sessions, participants will have to fill questionnaires about the use of medications, the Stanford Sleepiness Scale, the Leeds Sleep Evaluation Questionnaire, and the first part of the State and Trait Anxiety Questionnaire. During sensory stimulation, an infrared camera will be used to measure pupil diameter which constitute an indirect correlate of stimulus-evoked phasic variations in activity of the locus coeruleus. In order to measure autonomic reactivity to pain stimuli, the heart rate variability will be measured by recording electrocardiography. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18 and 65 years
- Ability to provide written informed consent
- Understanding French
Key exclusion criteria (18 listed)
- Current or recent (< 2 months) use of antibiotics, probiotics, fiber supplements or any other molecule that modifies intestinal transit.
- Current or recent (< 1 month) use of non-steroidal anti-inflammatory drugs and glucocorticoids
- Not willing or able to abstain from acute alcohol intoxication from 7 days prior to each of the two study sessions.
- Consumption of alcohol 24 hours prior to each of the two study sessions.
- Consumption of hypnotics, centrally-acting analgesics or psychotropic drugs.
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 |
|---|---|---|
| Screening visitThe participants will be screened for inclusion and exclusion criteria and will be asked to fill the following questionnaires : Pittsburgh Sleep Quality Index, State and Trait Anxiety Questionnaire, Pain Catastrophizing Scale Fear of Pain Questionnaire, Perceived Stress Scale, Beck Depression Inventory, and questionnaires to assess their health status and the use of medications. A blood sample (to measure pro- and anti-inflammatory cytokines and perform metabolomic analyses) will be obtained. Enrolled participants will be given a wearable actimeter to assess daily total sleep duration during one week before the first experimental session. They will also be requested to complete daily a sleep diary during one week before each experimental session, and a food diary before the first experimental session. A fecal sample (to assess gut microbiota composition and perform metabolomic analyses) will be collected between the screening visit and the first experimental session. | Other | Session 1 : Central Session (left) - session 2 Peripheral Session (right), Session 1 : Central Session (right) - session 2 Peripheral Session (left), Session 1 : Peripheral Session (left) - session 2 Central Session (right), Session 1 : Peripheral Session (right) - session 2 Central Session (left) |
| Peripheral sensitization sessionThe extent of neurogenic inflammation induced by topical capsaicin will be used as a measure of the susceptibility to sensitize at peripheral level. A solution of capsaicin will be applied to the skin of the left or right volar forearm for 30 minutes. The capsaicin-induced neurogenic inflammation can be quantified by assessing the intensity, extent and duration of the capsaicin-induced cutaneous flare response using thermal infrared imaging. Using heat stimuli delivered to the treated skin and surrounding skin, the intensity and duration of the capsaicin-induced hyperalgesia will also be assessed. The experimental session will last approximately two hours. | Other | Session 1 : Central Session (left) - session 2 Peripheral Session (right), Session 1 : Central Session (right) - session 2 Peripheral Session (left), Session 1 : Peripheral Session (left) - session 2 Central Session (right), Session 1 : Peripheral Session (right) - session 2 Central Session (left) |
| Central sensitization sessionThe extent of secondary mechanical hyperalgesia induced by high-frequency electrical stimulation (HFS) of the skin of the left or right volar forearm will be used as a measure of the susceptibility to develop central sensitization. The stimulation will be delivered using a multi-pin electrode designed to preferentially activate epidermal free nerve endings. The strength, spatial extent and duration of the HFS-induced changes in pinprick sensitivity will be characterized by using calibrated mechanical pinprick stimuli. The experimental session will last approximately one hour. | Other | Session 1 : Central Session (left) - session 2 Peripheral Session (right), Session 1 : Central Session (right) - session 2 Peripheral Session (left), Session 1 : Peripheral Session (left) - session 2 Central Session (right), Session 1 : Peripheral Session (right) - session 2 Central Session (left) |
Primary outcome
Correlation between composition of the intestinal microbiota and its metabolites and the susceptibility of sensitization at the peripheral and central levels.
Time frame: one week
A stool sample and a blood sample will be taken. These samples will be used to characterize the composition of the intestinal microbiota, as well as the metabolites produced by this microbiota. These analyses will allow a comparison of the composition of the microbiota and the metabolites in subjects with a tendency to develop low vs. high sensitization at the peripheral and central levels. The gut microbiota composition will be analyzed using 16S rDNA sequencing. Untargeted metabolite profiling, in fecal and blood samples, will be performed using liquid chromatography (LC) coupled with tandem mass spectrometry (MS-MS) platforms.
Correlation between sleep quality and the susceptibility of sensitization at the peripheral and central levels.
Time frame: five weeks
Sleep quality will be assessed using questionnaires and a measurement of the participant's sleep using a wrist movement sensitive bracelet. This information will be used to assess whether some of the inter-individual variability in developing peripheral or central sensitization might be related to differences in sleep quality.
Correlation between sleep duration and the susceptibility of sensitization at the peripheral and central levels.
Time frame: five weeks
Average sleep duration will be assessed using questionnaires and a measurement of the participant's sleep using a wrist movement sensitive bracelet. This information will be used to assess whether some of the inter-individual variability in developing peripheral or central sensitization might be related to differences in sleep duration.
3 secondary outcomes
Correlation between levels of systemic pro- and anti-inflammatory cytokines measured by multiplex assays and the susceptibility of sensitization at the peripheral and central levels.
Time frame: one week
Correlation between pupil diameter and the susceptibility of sensitization at the peripheral and central levels.
Time frame: five weeks
Correlation between heart rate variability and the susceptibility of sensitization at the peripheral and central levels.
Time frame: five weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
André Mouraux, MD, PhD principal investigator
UCLouvain, IONS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening visit, Peripheral sensitization session and Central sensitization session in people with Sensitization, Central and Peripheral Sensitization, run by Université Catholique de Louvain at 1 site in Belgium.
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 3 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 30 Jan 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gwenaëlle Mievis, PhD Student (+32488451915, gwenaelle.mievis@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between composition of the intestinal microbiota and its metabolites and the susceptibility of sensitization at the peripheral and central levels. (time frame: one week). The study lists 3 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 30 Jan 2024; AzTrials last refreshed its copy on 2 Nov 2026.