HealthyPhase 1NCT06325150
The Impact of Light Exposure on Cognitive Function in Classrooms
A Phase 1 study testing Light emitting glasses in people with Healthy, run by Michigan State University at 1 site in United States.
Trial summary
Humans are constantly exposed to a variety of light types, created naturally or through artificial means. Light exposure captured by the eyes impacts many physiological functions in humans, including but not limited to cognitive output, fatigue levels, and mood regulation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Light emitting glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to 1 Feb 2028
- Phase
- Phase 1
- 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
- Current Michigan State University (MSU) Undergraduate Student
- Are 18 years or older
- Healthy subject without light sensitivity
- Average bedtime 9:30 pm - 2:00 am, 6 out of 7 days a week
- Willingness to measure and report fatigue levels
- Willingness to participate in cognitive testing
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- Willingness to wear light-enriched glasses in the classroom
- Inclusion criteria for the control group (will not wear light glasses):
- Current Michigan State University (MSU) Undergraduate Student
- Are 18 years or older
- Average bedtime 9:30 pm - 2:00 am, 6 out of 7 days a week
- Willingness to measure and report fatigue levels
- Willingness to participate in cognitive testing
- Inclusion criteria for the control group (will not wear light glasses):
- Current Michigan State University (MSU) Undergraduate Student
- Are 18 years or older
- Average bedtime 9:30 pm - 2:00 am, 6 out of 7 days a week
- Willingness to measure and report fatigue levels
- Willingness to participate in cognitive testing
Who cannot join
- Are younger than 18 years of age
- Participation in shift work (evening/night shifts, early morning shifts, rotating shifts, etc.)
- Pregnant women
- Previous diagnosis of diabetes
- Use of medication that would cause sensitivity to light (e.g., antidepressants, antibiotics,prescribed sleep medication, prescribed pain meds)
- Epilepsy or a history of seizures
Show all 12Show fewer
- Photophobia - sensitivity or eye discomfort to bright light
- Eye Diseases that limit the ability of light to be processed (e.g., untreated cataracts,severe glaucoma, macular degeneration, blindness, pupil dilation problems, or retinadamage)
- Previous eye surgery
- Previous head injuries (e.g., concussions)
- Current chronic, severe headaches/migraines
- Clinical insomniacs or those with diagnosed sleep disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Michigan State University
East Lansing, Michigan, 48824
Hanne M Hoffmann, PhD, 517-353-1415, hanne@msu.edu
About this study
Humans are constantly exposed to a variety of light types, created naturally or through artificial means. Light exposure captured by the eyes impacts many physiological functions in humans, including but not limited to cognitive output, fatigue levels, and mood regulation. The level of impact on cognitive learning from different types of light on undergraduate adult students remains unclear.
Read the detailed description
This study has chosen to test light's impact on adult (18 years and older) undergraduate students' cognitive function. We hypothesize that students who wear light-enriched Type1 glasses (bright light emitting glasses) for one session (20 minutes) will experience greater cognitive function, than those who either wear light-enriched Type 2 glasses(placebo light) or no glasses at all.
This study will answer the following questions:
- After a single session (20 minutes) of wearing light-enriched glasses, on average how much did the students' cognitive function increase as compared to students without light-enriched glasses?
- Does cognitive function increase to a comparable degree using both types of light-enriched glasses for a single session (20 minutes)?
- Does the time of day impact the effects of light-enriched glasses during a single session (20 minutes), thus improve cognitive function?
- Does time of day impact cognitive function for students who do not participate in light-enriched testing? The study will gather additional data variables on the following questions:
- After wearing either type of light-enriched glasses, did the student's fatigue decrease throughout the study? How does this data compare to those who did not take part in light glasses testing?
- After wearing either type of light-enriched glasses, did the student's mood increase throughout the study? How does this data compare to those who did not take part in light glasses testing?
- How does the compiled data from the questionnaires and tests compare to sleep data collected from Smart Watches?
Objectives:
- Data points from participants will be captured through the following questionnaires and testing methods:
- Consent Form (~ 4 min)
- Student Questionnaire (~ 2 min) [Demographics]
- Chronotype Questionnaire, Morningness - Eveningness Self-Assessment * (~ 4 min)[This document tells you if you are an early bird or a night owl.]
- Pittsburgh Sleep Questionnaire* (~ 2 min) [This document tells you your sleep quality.]
- PHQ-9 Test * (~ 2 min) [This document assesses your mood.]
- PROMIS Fatigue Score Test [Measures your current fatigue levels.]
- Trail Making Test [Measures your cognitive function.]
- Additional data variables will be obtained from sleep data captured on personal Smart Watches by participants in the study. In the Student Questionnaire, participants are asked if they would be willing and able to provide the research team with their personal sleep data, covering a time period of two weeks prior to the study and three weeks during the study. This will enable researchers to compare Smart Watch data with fatigue scores and the Sleep Quality Index (Pittsburgh Sleep Questionnaire).
- Prior to testing, light composition readings will be taken from numerous locations within the classrooms and outdoors. Light readings will be obtained through a Spectral Light Meter. These readings will allow the researchers to control for ambient light exposure prior to the testing of the light emitting glasses.
- Conditions
- Healthy
- Being tested
- Light emitting glasses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light emitting glassesDevice
Assess the capacity of 20 min use of AYO light emitting glasses on different outcomes
| Study group | Role | What they receive |
|---|---|---|
| Light glasses type 1 | Experimental | Experimental light emitting glasses. Receives: Device: Light emitting glasses |
| Light glasses type 2 | Placebo comparator | Placebo light emitting glasses Receives: Device: Light emitting glasses |
| No glasses control | No intervention | No glasses control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of attention
To measure the impact of the intervention on attention, for each student we will measure the time it takes for the student to complete the provided test, and the number of errors in the test. Each student will completed the test, before and after the intervention, and the change in test score (time and errors) calculated.
Measured: 3 weeks. One test per week
Secondary outcomes (1)
Determine how time of day impacts attention
To determine how time of day impacts attention, we will reanalyze the data from "Outcome 1", and control for the time of day the students participated in the study. We will measure the time it took to complete the test, as well as the number of errors in the test.
Measured: 3 weeks. One test per week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start15 Sep 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study will test the effect of light emitting glasses, vs placebo, vs no-glasses to attention in college students. This is a crossover study, where participants will be randomly assigned to one of three groups, and tested in random order. The students will be tested on 2 or 3 different conditions (no glasses, placebo or light emitting glasses). The assignment to each of the groups, and the order of the intervention (+/- glasses) will be randomized. Note-light emitting glasses are not FDA regulated. Because light emitting glasses can change physiology, this is considered a phase 1 clinical trial.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanne M Hoffmann, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325150
- Sponsor's protocol ID
- STUDY00008572
- Status last verified
- Sep 2026
- First submitted
- 17 Jan 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Light Exposure on Cognitive Function in Classrooms
- ClinicalTrials.gov ID
- NCT06325150
- Acronym / sponsor ID
- STUDY00008572
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 22 Mar 2024 (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.
Humans are constantly exposed to a variety of light types, created naturally or through artificial means. Light exposure captured by the eyes impacts many physiological functions in humans, including but not limited to cognitive output, fatigue levels, and mood regulation. The level of impact on cognitive learning from different types of light on undergraduate adult students remains unclear.
Detailed description
This study has chosen to test light's impact on adult (18 years and older) undergraduate students' cognitive function. We hypothesize that students who wear light-enriched Type1 glasses (bright light emitting glasses) for one session (20 minutes) will experience greater cognitive function, than those who either wear light-enriched Type 2 glasses(placebo light) or no glasses at all.
This study will answer the following questions:
- After a single session (20 minutes) of wearing light-enriched glasses, on average how much did the students' cognitive function increase as compared to students without light-enriched glasses?
- Does cognitive function increase to a comparable degree using both types of light-enriched glasses for a single session (20 minutes)?
- Does the time of day impact the effects of light-enriched glasses during a single session (20 minutes), thus improve cognitive function?
- Does time of day impact cognitive function for students who do not participate in light-enriched testing? The study will gather additional data variables on the following questions:
- After wearing either type of light-enriched glasses, did the student's fatigue decrease throughout the study? How does this data compare to those who did not take part in light glasses testing?
- After wearing either type of light-enriched glasses, did the student's mood increase throughout the study? How does this data compare to those who did not take part in light glasses testing?
- How does the compiled data from the questionnaires and tests compare to sleep data collected from Smart Watches?
Objectives:
- Data points from participants will be captured through the following questionnaires and testing methods:
- Consent Form (~ 4 min)
- Student Questionnaire (~ 2 min) [Demographics]
- Chronotype Questionnaire, Morningness - Eveningness Self-Assessment * (~ 4 min)[This document tells you if you are an early bird or a night owl.]
- Pittsburgh Sleep Questionnaire* (~ 2 min) [This document tells you your sleep quality.]
- PHQ-9 Test * (~ 2 min) [This document assesses your mood.]
- PROMIS Fatigue Score Test [Measures your current fatigue levels.]
- Trail Making Test [Measures your cognitive function.]
- Additional data variables will be obtained from sleep data captured on personal Smart Watches by participants in the study. In the Student Questionnaire, participants are asked if they would be willing and able to provide the research team with their personal sleep data, covering a time period of two weeks prior to the study and three weeks during the study. This will enable researchers to compare Smart Watch data with fatigue scores and the Sleep Quality Index (Pittsburgh Sleep Questionnaire).
- Prior to testing, light composition readings will be taken from numerous locations within the classrooms and outdoors. Light readings will be obtained through a Spectral Light Meter. These readings will allow the researchers to control for ambient light exposure prior to the testing of the light emitting glasses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- This study will test the effect of light emitting glasses, vs placebo, vs no-glasses to attention in college students. This is a crossover study, where participants will be randomly assigned to one of three groups, and tested in random order. The students will be tested on 2 or 3 different conditions (no glasses, placebo or light emitting glasses). The assignment to each of the groups, and the order of the intervention (+/- glasses) will be randomized. Note-light emitting glasses are not FDA regulated. Because light emitting glasses can change physiology, this is considered a phase 1 clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Light glasses type 1 | Experimental | Device: Light emitting glassesExperimental light emitting glasses. |
| Light glasses type 2 | Placebo comparator | Device: Light emitting glassesPlacebo light emitting glasses |
| No glasses control | No intervention | –No glasses control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Current Michigan State University (MSU) Undergraduate Student
- Are 18 years or older
- Healthy subject without light sensitivity
- Average bedtime 9:30 pm - 2:00 am, 6 out of 7 days a week
- Willingness to measure and report fatigue levels
Key exclusion criteria (12 listed)
- Are younger than 18 years of age
- Participation in shift work (evening/night shifts, early morning shifts, rotating shifts, etc.)
- Pregnant women
- Previous diagnosis of diabetes
- Use of medication that would cause sensitivity to light (e.g., antidepressants, antibiotics,prescribed sleep medication, prescribed pain meds)
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 |
|---|---|---|
| Light emitting glassesAssess the capacity of 20 min use of AYO light emitting glasses on different outcomes | Device | Light glasses type 1, Light glasses type 2 |
Primary outcome
Assessment of attention
Time frame: 3 weeks. One test per week
To measure the impact of the intervention on attention, for each student we will measure the time it takes for the student to complete the provided test, and the number of errors in the test. Each student will completed the test, before and after the intervention, and the change in test score (time and errors) calculated.
1 secondary outcome
Determine how time of day impacts attention
Time frame: 3 weeks. One test per week
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 17 Sep 2026.
- Website of glasses used for studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Light emitting glasses in people with Healthy, run by Michigan State University at 1 site in United States.
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 19 inclusion and 12 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 17 Sep 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hanne M Hoffmann, PhD (517 353 1415, hanne@msu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of attention (time frame: 3 weeks. One test per week). 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 17 Sep 2026.