Sleep DisordersNCT03811964
Photomotor Reflex to Evaluate the Role of the Non-visual Effects of Light in Neurological, Psychiatric and Ophthalmological Pathologies
A study testing Specific light exposures in people with Sleep Disorders and Neurological Pathologies, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders, Neurological Pathologies, Psychiatric Pathologies
- What is being tested?
- Specific light exposures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 726 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2020to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital, Strasbourg, France
Strasbourg, 67000
Bourgin Patrice, MD, 03 88 11 64 30 ext. 0033, pbourgin@unistra.fr
About this study
Official title: 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
- Conditions
- Sleep Disorders, Neurological Pathologies, Psychiatric Pathologies, Ophthalmological Pathologies
- Being tested
- Specific light exposures
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific light exposuresOther
Specific light exposures using light in a wide range of intensities or different light/dark regimens
| Study group | Role | What they receive |
|---|---|---|
| primary sleep-wake disorder | Other | Subjects with primary sleep-wake disorder Receives: Other: Specific light exposures |
| neurological pathology | Other | subjects presenting a neurological pathology with disorder of the controls of the wake and the sleep Receives: Other: Specific light exposures |
| psychiatric pathology | Other | subject presenting a psychiatric pathology with disorder of the controls of the wake and the sleep Receives: Other: Specific light exposures |
| ophthalmological pathology | Other | subject presenting an ophthalmological pathology with possible alteration of the photoreception and / or phototransduction Receives: Other: Specific light exposures |
| photosensitivity | Other | subjects with photosensitivity with regulation disorder of sleep and wake Receives: Other: Specific light exposures |
| group control | Other | healthy subject Receives: Other: Specific light exposures |
What is being measured
The primary outcome is the main question the study is designed to answer.
PIPR : Post-Illumination Pupil Response
1 measurement per subject is performed after exposure to monochromatic light exposure
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start22 Jan 2020
- Primary completionJan 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 726 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bourgin Patrice, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811964
- Sponsor's protocol ID
- 6791
- Status last verified
- Aug 2026
- First submitted
- 9 Jan 2019
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Photomotor Reflex to Evaluate the Role of the Non-visual Effects of Light in Neurological, Psychiatric and Ophthalmological Pathologies
- ClinicalTrials.gov ID
- NCT03811964
- Acronym / sponsor ID
- 6791
- Conditions
- Sleep Disorders, Neurological Pathologies, Psychiatric Pathologies, Ophthalmological Pathologies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 726 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| primary sleep-wake disorder | Other | Other: Specific light exposuresSubjects with primary sleep-wake disorder |
| neurological pathology | Other | Other: Specific light exposuressubjects presenting a neurological pathology with disorder of the controls of the wake and the sleep |
| psychiatric pathology | Other | Other: Specific light exposuressubject presenting a psychiatric pathology with disorder of the controls of the wake and the sleep |
| ophthalmological pathology | Other | Other: Specific light exposuressubject presenting an ophthalmological pathology with possible alteration of the photoreception and / or phototransduction |
| photosensitivity | Other | Other: Specific light exposuressubjects with photosensitivity with regulation disorder of sleep and wake |
| group control | Other | Other: Specific light exposureshealthy subject |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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, ...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific light exposuresSpecific light exposures using light in a wide range of intensities or different light/dark regimens | Other | group control, neurological pathology, ophthalmological pathology, photosensitivity, primary sleep-wake disorder, psychiatric pathology |
Primary outcome
PIPR : Post-Illumination Pupil Response
Time frame: 1 day
1 measurement per subject is performed after exposure to monochromatic light exposure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
Related trials for Sleep Disorders
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bourgin Patrice, MD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific light exposures in people with Sleep Disorders and Neurological Pathologies, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bourgin Patrice, MD (03 88 11 64 30 ext. 0033, pbourgin@unistra.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PIPR : Post-Illumination Pupil Response (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.