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

Primary Purpose

Sleep Disorders, Neurological Pathologies, Psychiatric Pathologies

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Specific light exposures

About this trial

This is an interventional health services research trial for Sleep Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University Hospital, Strasbourg, FranceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Other

Arm Label

primary sleep-wake disorder

neurological pathology

psychiatric pathology

ophthalmological pathology

photosensitivity

group control

Arm Description

Subjects with primary sleep-wake disorder

subjects presenting a neurological pathology with disorder of the controls of the wake and the sleep

subject presenting a psychiatric pathology with disorder of the controls of the wake and the sleep

subject presenting an ophthalmological pathology with possible alteration of the photoreception and / or phototransduction

subjects with photosensitivity with regulation disorder of sleep and wake

healthy subject

Outcomes

Primary Outcome Measures

PIPR : Post-Illumination Pupil Response

1 measurement per subject is performed after exposure to monochromatic light exposure

Secondary Outcome Measures

Full Information

NCT ID

NCT03811964

First Posted

January 9, 2019

Last Updated

August 10, 2023

Sponsor

University Hospital, Strasbourg, France

1. Study Identification

Unique Protocol Identification Number

NCT03811964

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 22, 2020 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Disorders, Neurological Pathologies, Psychiatric Pathologies, Ophthalmological Pathologies

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

726 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

primary sleep-wake disorder

Arm Type

Other

Arm Description

Subjects with primary sleep-wake disorder

Arm Title

neurological pathology

Arm Type

Other

Arm Description

subjects presenting a neurological pathology with disorder of the controls of the wake and the sleep

Arm Title

psychiatric pathology

Arm Type

Other

Arm Description

subject presenting a psychiatric pathology with disorder of the controls of the wake and the sleep

Arm Title

ophthalmological pathology

Arm Type

Other

Arm Description

subject presenting an ophthalmological pathology with possible alteration of the photoreception and / or phototransduction

Arm Title

photosensitivity

Arm Type

Other

Arm Description

subjects with photosensitivity with regulation disorder of sleep and wake

Arm Title

group control

Arm Type

Other

Arm Description

healthy subject

Intervention Type

Other

Intervention Name(s)

Specific light exposures

Intervention Description

Specific light exposures using light in a wide range of intensities or different light/dark regimens

Primary Outcome Measure Information:

Title

PIPR : Post-Illumination Pupil Response

Description

1 measurement per subject is performed after exposure to monochromatic light exposure

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bourgin Patrice, MD

Phone

03 88 11 64 30

Ext

0033

pbourgin@unistra.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bourgin Patrice, MD

Organizational Affiliation

University Hospital, Strasbourg, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital, Strasbourg, France

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bourgin Patrice, MD

Phone

03 88 11 64 30

Ext

0033

pbourgin@unistra.fr

12. IPD Sharing Statement

Learn more about this trial

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

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