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临床试验/NCT03811964
NCT03811964招募中不适用

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

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 726 人开始时间: 2020年1月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
726
试验地点
2
主要终点
PIPR : Post-Illumination Pupil Response

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

neurological pathology

Other

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

干预措施: Specific light exposures (Other)

psychiatric pathology

Other

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

干预措施: Specific light exposures (Other)

ophthalmological pathology

Other

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

干预措施: Specific light exposures (Other)

photosensitivity

Other

subjects with photosensitivity with regulation disorder of sleep and wake

干预措施: Specific light exposures (Other)

group control

Other

healthy subject

干预措施: Specific light exposures (Other)

primary sleep-wake disorder

Other

Subjects with primary sleep-wake disorder

干预措施: Specific light exposures (Other)

结局指标

主要结局

PIPR : Post-Illumination Pupil Response

时间窗: 1 day

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

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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