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Recruiting NCT03811964

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

No phase Interventional Sleep Disorders Neurological Pathologies Psychiatric Pathologies Ophthalmological Pathologies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Specific light exposures.
Who it may be relevant to
Registry conditions: Sleep Disorders, Neurological Pathologies, Psychiatric Pathologies, Ophthalmological Pathologies. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • PIPR : Post-Illumination Pupil Response [Time frame: 1 day]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

France · 1 center
  • University Hospital, Strasbourg, France — Strasbourg

Identifiers

NCT: NCT03811964 · 6791

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗