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Photomotor Reflex to Evaluate the Role of the Non-visual Effects of Light in Neurological, Psychiatric and Ophthalmological Pathologies

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ClinicalTrials.gov Identifier: NCT03811964
Recruitment Status : Recruiting
First Posted : January 22, 2019
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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Brief Summary:
The light has visual and non-visual effects on organism and can act on the behavior, the mood, the cognition and the sleep. These effects are mediated by "classical" retina photoreceptors which allow vision (rods, cones) but also melanopsin cells. The non-visual effects of light seems to be altered in many neurological, psychiatric or ophtalmological conditions but their exact role in the pathogenesis remains poorly understand. The purpose of the study is to increase our knowledge of the non-visual effects of light and establish new therapeutic applications

Condition or disease Intervention/treatment Phase
Sleep Disorders Neurological Pathologies Psychiatric Pathologies Ophthalmological Pathologies Other: Specific light exposures Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 726 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Study of the Photomotor Reflex to Evaluate the Role of the Non-visual Effects of Light in Neurological, Psychiatric and Ophthalmological Pathologies
Actual Study Start Date : January 22, 2020
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : February 2024
Arms and Interventions
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Arm Intervention/treatment
primary sleep-wake disorder
Subjects with primary sleep-wake disorder
 Other: Specific light exposures
Specific light exposures using light in a wide range of intensities or different light/dark regimens
neurological pathology
subjects presenting a neurological pathology with disorder of the controls of the wake and the sleep
 Other: Specific light exposures
Specific light exposures using light in a wide range of intensities or different light/dark regimens
psychiatric pathology
subject presenting a psychiatric pathology with disorder of the controls of the wake and the sleep
 Other: Specific light exposures
Specific light exposures using light in a wide range of intensities or different light/dark regimens
ophthalmological pathology
subject presenting an ophthalmological pathology with possible alteration of the photoreception and / or phototransduction
 Other: Specific light exposures
Specific light exposures using light in a wide range of intensities or different light/dark regimens
photosensitivity
subjects with photosensitivity with regulation disorder of sleep and wake
 Other: Specific light exposures
Specific light exposures using light in a wide range of intensities or different light/dark regimens
group control
healthy subject
 Other: Specific light exposures
Specific light exposures using light in a wide range of intensities or different light/dark regimens


Outcome Measures
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Primary Outcome Measures :
  1. PIPR : Post-Illumination Pupil Response [ Time Frame: 1 day ]
    1 measurement per subject is performed after exposure to monochromatic light exposure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Man or woman
  • Aged 18 years or older
  • Subject having signed a free and informed consent
  • Subject affiliated to a social protection scheme Arm 1 :Subjects with primary sleep-wake disorder Arm 2 : subjects presenting a neurological pathology with disorder of the controls of the wake and the sleep Arm 3 : subject presenting a psychiatric pathology pathology with disorder of the controls of the wake and the sleep Arm 4 : subject presenting an ophthalmological pathology with possible alteration of the photoreception and / or phototransduction Arm 5 : subjects with photosensitivity with regulation disorder of sleep and wake Arm 6 : healthy subject

Exclusion Criteria:

Age-Related Macular Degeneration (AMD) and all maculopathies (retinopathies pigmentosa, macular involvement of diabetes)

  • Cataract with significant vision loss <5/10
  • Chorioretinal neovascularization
  • Subject in exclusion period determined by previous or current study
  • Impossibility to give the subject information enlightened (subject in emergency situation, difficulties of understanding the subject, ...)
  • Subject under the protection of justice
  • Subject under guardianship or curatorship
  • Pregnancy / Breastfeeding
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811964


Contacts
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Contact: Bourgin Patrice, MD 03 88 11 64 30 ext 0033 pbourgin@unistra.fr

Locations
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France
University Hospital, Strasbourg, France Recruiting
Strasbourg, France, 67000
Contact: Bourgin Patrice, MD    03 88 11 64 30 ext 0033    pbourgin@unistra.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Bourgin Patrice, MD University Hospital, Strasbourg, France
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03811964    
Other Study ID Numbers: 6791
First Posted: January 22, 2019    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders