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Nociceptive PainNCT04864340

Clinical Trial Using Pupillometry to Measure Nociception in Healthy Volunteers.

A study testing CE marked medical device, Algometer and Comparator in people with Nociceptive Pain and Pupillary Light Reflex Lost, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 65 yearsHealthy volunteers can take part
What is being tested?
CE marked medical device, Algometer and Comparator
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteSpain
Study dates
30 Apr 2021to May 2021
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 25 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site, 1 recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

    Maria Rosa Ballester, PhD, mballesterv@santpau.cat

    +34935537855

    Recruiting

Other trials in Spain

About this study

Official title: Crossover Randomized Clinical Trial to Evaluate the Effectiveness and Safety of Pupillometry as an Objective Measurement of Nociception in Healthy Volunteers.

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.

Being tested
CE marked medical device, Algometer, Comparator
Medical subject headings
Nociceptive Pain, Pain, Procedural, Coitus, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CE marked medical deviceDevice

    Tetanic stimulation

  • AlgometerDevice

    Pressure stimulation

  • ComparatorProcedure or surgery

    Non-nociceptive procedure (fine touch)

Study groups in NCT04864340
Study groupRoleWhat they receive
threshold stimulation (tetanic)ExperimentalNot described
Receives: Device: CE marked medical device
upper threshold stimulation (tetanic)ExperimentalNot described
Receives: Device: CE marked medical device
threshold stimulation (pressure)ExperimentalNot described
Receives: Device: Algometer
upper threshold stimulation (pressure)ExperimentalNot described
Receives: Device: Algometer
non nociceptive procedure (fine touch)Placebo comparatorNot described
Receives: Procedure: Comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Pupillary Dilatation Reflex (PDR)

    Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan®

    Measured: Change in Pupillary Dilatation Reflex (PDR) from baseline to +10 minutes (with non-nociceptive procedure (fine touch))

  2. Change in Pupillary Dilatation Reflex (PDR)

    Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)

    Measured: Change in Pupillary Dilatation Reflex (PDR) from baseline to 20 minutes after tetanic stimulation (by Algiscan®)

  3. Change in Pupillary Dilatation Reflex (PDR)

    Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)

    Measured: Change in Pupillary Dilatation Reflex (PDR) from baseline to 30 minutes after tetanic stimulation (by Algiscan®)

  4. Change in Pupillary Dilatation Reflex (PDR)

    Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)

    Measured: Change in Pupillary Dilatation Reflex (PDR) from baseline to 40 minutes after tetanic stimulation (by Algiscan®)

  5. Change in Pupillary Dilatation Reflex (PDR)

    Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)

    Measured: Change in Pupillary Dilatation Reflex (PDR) from baseline to 50 minutes after tetanic stimulation (by Algiscan®)

Secondary outcomes (4)

  1. Change in Pupillary Dilatation Reflex (PDR)

    Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)

    Measured: Change in Pupillary Dilatation Reflex (PDR) from baseline to + 60 minutes after pressure estimulation

  2. Change in Pupillary Dilatation Reflex (PDR)

    Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)

    Measured: Change in Pupillary Dilatation Reflex (PDR) from baseline to +70 minutes after pressure estimulation

  3. Change in Pupillary Dilatation Reflex (PDR)

    Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)

    Measured: Change in Pupillary Dilatation Reflex (PDR) from baseline to +80 minutes after pressure estimulation

  4. Change in Pupillary Dilatation Reflex (PDR)

    Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)

    Measured: Change in Pupillary Dilatation Reflex (PDR) from baseline to +90 minutes after pressure estimulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2021
  2. Study start30 Apr 2021
  3. Primary completionMay 2021 (estimated)
  4. Study completionMay 2021 (estimated)

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04864340
Sponsor's protocol ID
IIBSP-PUP-2019-01
Status last verified
May 2021
First submitted
13 Apr 2021
Last updated
19 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing CE marked medical device, Algometer and Comparator in people with Nociceptive Pain and Pupillary Light Reflex Lost, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

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 6 inclusion and 9 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 19 May 2021. 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 Spain. 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. Some participants in this study may receive a placebo. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pupillary Dilatation Reflex (PDR) (time frame: Change in Pupillary Dilatation Reflex (PDR) from baseline to +10 minutes (with non-nociceptive procedure (fine touch))). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04864340.

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 19 May 2021.

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