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

Sleep Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03811964
• Other study ID #: 6791
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2020
• Est. completion date: February 2024

Study information

• Verified date: August 2023
• Source: University Hospital, Strasbourg, France
• Contact: Bourgin Patrice, MD
• Phone: 03 88 11 64 30
• Email: pbourgin[@]unistra.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 726
• Est. completion date: February 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurological Pathologies
• Ophthalmological Pathologies
• Psychiatric Pathologies
• Sleep Disorders
• Sleep Wake Disorders

Intervention

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

Locations

Country	Name	City	State
France	University Hospital, Strasbourg, France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PIPR : Post-Illumination Pupil Response	1 measurement per subject is performed after exposure to monochromatic light exposure	1 day