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

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

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

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorders; Neurological Pathologies; Psychiatric Pathologies; Ophthalmological Pathologies
• Intervention / Treatment: Other: Specific light exposures

• Study Type: Interventional
• Enrollment (Estimated): 726
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bourgin Patrice, MD; Phone Number: 0033 03 88 11 64 30; Email: pbourgin@unistra.fr

Study Locations

• France
  • Strasbourg, France, 67000
    • Recruiting
    • University Hospital, Strasbourg, France
    • Contact: Bourgin Patrice, MD; Phone Number: 0033 03 88 11 64 30; Email: pbourgin@unistra.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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
Other: 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
Other: 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
Other: 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
Other: group control; healthy subject	Other: Specific light exposures; Specific light exposures using light in a wide range of intensities or different light/dark regimens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PIPR : Post-Illumination Pupil Response	1 measurement per subject is performed after exposure to monochromatic light exposure	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Bourgin Patrice, MD, University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2020
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 22, 2019

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders
• Other Study ID Numbers: 6791

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No