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Status unknownNCT04864340Updated May 19, 2021

Clinical Trial Using Pupillometry to Measure Nociception in Healthy Volunteers.

An interventional study of CE marked medical device and Algometer in Nociceptive Pain, Pupillary Light Reflex Lost and Healthy, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Status unknown at 1 site in Spain. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-19.

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nociceptive Pain
  • Pupillary Light Reflex Lost
  • Healthy
  • Pain, Procedural
  • Gender
  • Anxiety
03

In context

Nociceptive Pain

92 studies on the registry are indexed under Nociceptive Pain; 17 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 63 interventional studies indexed under Nociceptive Pain.

Browse Nociceptive Pain studies →

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Subjects of both sexes (balanced)
  2. Caucasian race
  3. Ages between 25 and 65 years old (balanced, 50% from 25-45 and 50% from 45-65)
  4. Body weight within the normal range (Quetelet index: 19-30)
  5. Clinical history, physical examination and vital signs within normality
  6. Free acceptance to participate, with written informed consent

Exclusion criteria

Exclusion Criteria:

  1. 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)
  2. Significant consumption of stimulating drinks (> 5 coffees, teas, chocolate or cola drinks / day).
  3. 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.
  4. Pregnancy (β-hCG test).
  5. Menstruation and / or dysmenorrhea on the day of the study
  6. 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
  7. Pupillary diameter ≥ 5mm
  8. Smokers or ex-smokers \<6 months.
  9. Have participated in a clinical trial in the 3 months prior to the start of this study.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    threshold stimulation (tetanic)

    Device: CE marked medical device

  • Experimental
    upper threshold stimulation (tetanic)

    Device: CE marked medical device

  • Experimental
    threshold stimulation (pressure)

    Device: Algometer

  • Experimental
    upper threshold stimulation (pressure)

    Device: Algometer

  • Placebo comparator
    non nociceptive procedure (fine touch)

    Procedure: Comparator

Interventions

  • DeviceCE marked medical device

    Tetanic stimulation

  • DeviceAlgometer

    Pressure stimulation

  • ProcedureComparator

    Non-nociceptive procedure (fine touch)

06

What researchers measure

Primary outcomes

  1. Change in Pupillary Dilatation Reflex (PDR)

    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))

  2. Change in Pupillary Dilatation Reflex (PDR)

    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®)

  3. Change in Pupillary Dilatation Reflex (PDR)

    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®)

  4. Change in Pupillary Dilatation Reflex (PDR)

    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®)

  5. Change in Pupillary Dilatation Reflex (PDR)

    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 outcomes

  1. Change in Pupillary Dilatation Reflex (PDR)

    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

  2. Change in Pupillary Dilatation Reflex (PDR)

    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

  3. Change in Pupillary Dilatation Reflex (PDR)

    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

  4. Change in Pupillary Dilatation Reflex (PDR)

    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

07

Study locations

1 of 1 sites recruiting
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, 08041, Spain
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04864340
Lead sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Responsible party
Sponsor
First posted
Apr 28, 2021
Start date
Apr 30, 2021
Primary completion
May 2021 (estimated)
Completion
May 2021 (estimated)
Last update
May 19, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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