Back to resultsClinical Trial Using Pupillometry to Measure Nociception in Healthy Volunteers.
Primary Purpose
Nociceptive Pain, Pupillary Light Reflex Lost, Healthy
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
CE marked medical device
Algometer
Comparator
Sponsored by
About this trial
This is an interventional other trial for Nociceptive Pain
Eligibility Criteria
Inclusion Criteria:
- Subjects of both sexes (balanced)
- Caucasian race
- Ages between 25 and 65 years old (balanced, 50% from 25-45 and 50% from 45-65)
- Body weight within the normal range (Quetelet index: 19-30)
- Clinical history, physical examination and vital signs within normality
- Free acceptance to participate, with written informed consent
Exclusion Criteria:
- Previous history of alcoholism or drug dependence (year prior to the screening visit or daily alcohol consumption> 40 gr / day for men or> 24 gr / day for women)
- Significant consumption of stimulating drinks (> 5 coffees, teas, chocolate or cola drinks / day).
- Taking any medication in the 15 days prior to the study and / or medicinal plants that may have an effect on the pupil (beta-blockers, droperidol, metoclopramide, clonidine ...). Oral contraceptives and paracetamol will be allowed.
- Pregnancy (β-hCG test).
- Menstruation and / or dysmenorrhea on the day of the study
- Family or personal history or clinical evidence of psychiatric, neurological or ophthalmological problems: anxiety, depression, Parkinson's, glaucoma, dry eyes, retinal diseases, eye surgery and pupil abnormalities, presenting migraine pathology and diabetes
- Pupillary diameter ≥ 5mm
- Smokers or ex-smokers <6 months.
- Have participated in a clinical trial in the 3 months prior to the start of this study.
Sites / Locations
- Hospital de la Santa Creu i Sant PauRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
threshold stimulation (tetanic)
upper threshold stimulation (tetanic)
threshold stimulation (pressure)
upper threshold stimulation (pressure)
non nociceptive procedure (fine touch)
Arm Description
Outcomes
Primary Outcome Measures
Change in Pupillary Dilatation Reflex (PDR)
Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan®
Change in Pupillary Dilatation Reflex (PDR)
Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)
Change in Pupillary Dilatation Reflex (PDR)
Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)
Change in Pupillary Dilatation Reflex (PDR)
Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)
Change in Pupillary Dilatation Reflex (PDR)
Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)
Secondary Outcome Measures
Change in Pupillary Dilatation Reflex (PDR)
Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)
Change in Pupillary Dilatation Reflex (PDR)
Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)
Change in Pupillary Dilatation Reflex (PDR)
Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)
Change in Pupillary Dilatation Reflex (PDR)
Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)
Full Information
NCT ID
NCT04864340
First Posted
April 13, 2021
Last Updated
May 17, 2021
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1. Study Identification
Unique Protocol Identification Number
NCT04864340
Brief Title
Clinical Trial Using Pupillometry to Measure Nociception in Healthy Volunteers.
Official Title
Crossover Randomized Clinical Trial to Evaluate the Effectiveness and Safety of Pupillometry as an Objective Measurement of Nociception in Healthy Volunteers.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pupillometry has been used in healthy volunteers to investigate the usefulness of the pupil light reflex as an indicator of pain intensity on pressure as a nociceptive stimulus. In this sense, it is necessary to check if the pupillometry is sensitive to different types or sources of pain. One of these devices is the Algiscan® portable pupillometer (IdMed, Marseille, France), which we propose to use in the present study. This pupillometer has previously been used in healthy volunteers, and in patients admitted to the intensive care unit, subjected to mechanical ventilation and sedation / analgesia.
This study in healthy volunteers aims to evaluate whether the PDR can be a reliable and discriminatory measure of the intensity of nociception, applying various types of nociceptive stimuli. If so, this study could lead to the use of pupillometry as an objective measure of nociception in settings where patients cannot communicate, such as intensive care areas or perioperative settings.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nociceptive Pain, Pupillary Light Reflex Lost, Healthy, Pain, Procedural, Gender, Anxiety
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
threshold stimulation (tetanic)
Arm Type
Experimental
Arm Title
upper threshold stimulation (tetanic)
Arm Type
Experimental
Arm Title
threshold stimulation (pressure)
Arm Type
Experimental
Arm Title
upper threshold stimulation (pressure)
Arm Type
Experimental
Arm Title
non nociceptive procedure (fine touch)
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
CE marked medical device
Intervention Description
Tetanic stimulation
Intervention Type
Device
Intervention Name(s)
Algometer
Intervention Description
Pressure stimulation
Intervention Type
Procedure
Intervention Name(s)
Comparator
Intervention Description
Non-nociceptive procedure (fine touch)
Primary Outcome Measure Information:
Title
Change in Pupillary Dilatation Reflex (PDR)
Description
Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan®
Time Frame
Change in Pupillary Dilatation Reflex (PDR) from baseline to +10 minutes (with non-nociceptive procedure (fine touch))
Title
Change in Pupillary Dilatation Reflex (PDR)
Description
Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)
Time Frame
Change in Pupillary Dilatation Reflex (PDR) from baseline to 20 minutes after tetanic stimulation (by Algiscan®)
Title
Change in Pupillary Dilatation Reflex (PDR)
Description
Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)
Time Frame
Change in Pupillary Dilatation Reflex (PDR) from baseline to 30 minutes after tetanic stimulation (by Algiscan®)
Title
Change in Pupillary Dilatation Reflex (PDR)
Description
Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)
Time Frame
Change in Pupillary Dilatation Reflex (PDR) from baseline to 40 minutes after tetanic stimulation (by Algiscan®)
Title
Change in Pupillary Dilatation Reflex (PDR)
Description
Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)
Time Frame
Change in Pupillary Dilatation Reflex (PDR) from baseline to 50 minutes after tetanic stimulation (by Algiscan®)
Secondary Outcome Measure Information:
Title
Change in Pupillary Dilatation Reflex (PDR)
Description
Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)
Time Frame
Change in Pupillary Dilatation Reflex (PDR) from baseline to + 60 minutes after pressure estimulation
Title
Change in Pupillary Dilatation Reflex (PDR)
Description
Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)
Time Frame
Change in Pupillary Dilatation Reflex (PDR) from baseline to +70 minutes after pressure estimulation
Title
Change in Pupillary Dilatation Reflex (PDR)
Description
Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)
Time Frame
Change in Pupillary Dilatation Reflex (PDR) from baseline to +80 minutes after pressure estimulation
Title
Change in Pupillary Dilatation Reflex (PDR)
Description
Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)
Time Frame
Change in Pupillary Dilatation Reflex (PDR) from baseline to +90 minutes after pressure estimulation
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects of both sexes (balanced)
Caucasian race
Ages between 25 and 65 years old (balanced, 50% from 25-45 and 50% from 45-65)
Body weight within the normal range (Quetelet index: 19-30)
Clinical history, physical examination and vital signs within normality
Free acceptance to participate, with written informed consent
Exclusion Criteria:
Previous history of alcoholism or drug dependence (year prior to the screening visit or daily alcohol consumption> 40 gr / day for men or> 24 gr / day for women)
Significant consumption of stimulating drinks (> 5 coffees, teas, chocolate or cola drinks / day).
Taking any medication in the 15 days prior to the study and / or medicinal plants that may have an effect on the pupil (beta-blockers, droperidol, metoclopramide, clonidine ...). Oral contraceptives and paracetamol will be allowed.
Pregnancy (β-hCG test).
Menstruation and / or dysmenorrhea on the day of the study
Family or personal history or clinical evidence of psychiatric, neurological or ophthalmological problems: anxiety, depression, Parkinson's, glaucoma, dry eyes, retinal diseases, eye surgery and pupil abnormalities, presenting migraine pathology and diabetes
Pupillary diameter ≥ 5mm
Smokers or ex-smokers <6 months.
Have participated in a clinical trial in the 3 months prior to the start of this study.
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Rosa Ballester, PhD
Email
mballesterv@santpau.cat
Phone
+34935537855
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial Using Pupillometry to Measure Nociception in Healthy Volunteers.
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