Circadian RhythmSCOPENCT07753889
Relationships Among Pupil Responses to Light, Circadian Rhythms, and Sleep
A study testing Ocular light exposure from portable light box in people with Circadian Rhythm and Pupillometry, run by Elizabeth B Klerman MD PhD at 1 site in United States.
Trial summary
The investigators are studying relationships among eye pathology, pupil responses to light, sleep, circadian rhythms, and hormones in healthy individuals and those with various medical disorders or illnesses. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Circadian Rhythm, Pupillometry, Sleep
- What is being tested?
- Ocular light exposure from portable light box
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2027to Dec 2035
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-85 years old.
- stable medically
- ability to speak, understand and read English at a high school level
Who cannot join
- any history of eye trauma or surgery besides correctable vision abnormalities (e.g., with glasses); any abnormalities on clinical eye exam (e.g., neuritis, Neuromyelitis optica, untreated glaucoma) such that the ophthalmologist recommends the participant not be studied;
- prescription or non-prescription drugs affecting the pupil (e.g., affecting autonomic function), sleep, melatonin (e.g., lithium, alpha- and beta-adrenergic antagonists), and/or circadian rhythms (e.g., beta blockers, non-steroidal anti-inflammatory drugs, tricyclics\
- shift- or night-work in past three months;
- crossing more than 2 time zones in past three months;
- pregnant or less than 6 months post-partum or breastfeeding.
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
MassGeneralBrigham
Boston, Massachusetts, 02114
Elizabeth Klerman, MD PhD, 617-643-2424, MGH_OSCAR@MGH.HARVARD.EDU
About this study
Official title: Documenting Relationships Among Pupil Responses to Light, Circadian Rhythms, and Sleep in Healthy People and Those With Disorders or Disease
The investigators are studying relationships among eye pathology, pupil responses to light, sleep, circadian rhythms, and hormones in healthy individuals and those with various medical disorders or illnesses.
All participants will:
Read more
- Answer questionnaires about their health
- Receive an eye exam,
- For one week at home, participants will track their sleep and wake using actigraphy (wrist worn wearable) and an online sleep diary.
- Complete a pupillometry session (measuring pupil size in response to different lighting) at MGH
Participants may also choose to participate in the following additional procedures in any order:
- Within one week of their pupillometry session, an at-home saliva collection under dim light. Saliva melatonin can be analyzed to determine Dim-Light-Melatonin-Onset (DLMO), a marker of circadian timing.
- If participants participate in one night saliva collection, a second night of at-home saliva collection with a bright light exposure to calculate melatonin suppression in response to light.
- Conditions
- Circadian Rhythm, Pupillometry, Sleep
- Being tested
- Ocular light exposure from portable light box
- Keywords
- Pupil (eye), Light, Circadian Rhythms, Sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular light exposure from portable light boxOther
One night of dim light exposure and one night of bright light exposure. Lighting from the portable light box
| Study group | Role | What they receive |
|---|---|---|
| Lighting intervention | Experimental | Pupillometry at MGH following by saliva collection during one night of dim light and then one night of bright light Receives: Other: Ocular light exposure from portable light box |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil size
Pupil size (mm) in response to pupillometry light stimuli using a pupillometry machine
Measured: 1 hour of pupillometry
Secondary outcomes (1)
Dim Light Melatonin Onset (DLMO) from saliva
Dim Light Melatonin Onset (DLMO) calculated from salivary melatonin collected during night of ocular dim light exposure
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Sep 2027 (estimated)
- Primary completionDec 2034 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian RhythmStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elizabeth B Klerman MD PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor-investigator, Elizabeth B Klerman MD PhD, Massachusetts General Hospital
- Investigators
- Elizabeth Klerman, MD PhD, Principal investigator, MGB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753889
- Sponsor's protocol ID
- 2025P002861
- Acronym
- SCOPE
- Status last verified
- Sep 2026
- First submitted
- 17 Mar 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Documenting Relationships Among Pupil Responses to Light, Circadian Rhythms, and Sleep in Healthy People and Those With Disorders or Disease
- ClinicalTrials.gov ID
- NCT07753889
- Acronym / sponsor ID
- SCOPE / 2025P002861
- Conditions
- Circadian Rhythm, Pupillometry, Sleep
- Keywords
- Pupil (eye), Light, Circadian Rhythms, Sleep
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Elizabeth B Klerman MD PhDUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 1 Sep 2027 (estimated)
- Primary completion
- Dec 2034 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 10 Aug 2026 (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 investigators are studying relationships among eye pathology, pupil responses to light, sleep, circadian rhythms, and hormones in healthy individuals and those with various medical disorders or illnesses.
All participants will:
- Answer questionnaires about their health
- Receive an eye exam,
- For one week at home, participants will track their sleep and wake using actigraphy (wrist worn wearable) and an online sleep diary.
- Complete a pupillometry session (measuring pupil size in response to different lighting) at MGH
Participants may also choose to participate in the following additional procedures in any order:
- Within one week of their pupillometry session, an at-home saliva collection under dim light. Saliva melatonin can be analyzed to determine Dim-Light-Melatonin-Onset (DLMO), a marker of circadian timing.
- If participants participate in one night saliva collection, a second night of at-home saliva collection with a bright light exposure to calculate melatonin suppression in response to light.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lighting intervention | Experimental | Other: Ocular light exposure from portable light boxPupillometry at MGH following by saliva collection during one night of dim light and then one night of bright light |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-85 years old.
- stable medically
- ability to speak, understand and read English at a high school level
Key exclusion criteria (5 listed)
- any history of eye trauma or surgery besides correctable vision abnormalities (e.g., with glasses); any abnormalities on clinical eye exam (e.g., neuritis, Neuromyelitis optica, untreated glaucoma) such that the ophthalmologist recommends the participant not be studied;
- prescription or non-prescription drugs affecting the pupil (e.g., affecting autonomic function), sleep, melatonin (e.g., lithium, alpha- and beta-adrenergic antagonists), and/or circadian rhythms (e.g., beta blockers, non-steroidal anti-inflammatory drugs, tricyclics\
- shift- or night-work in past three months;
- crossing more than 2 time zones in past three months;
- pregnant or less than 6 months post-partum or breastfeeding.
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 |
|---|---|---|
| Ocular light exposure from portable light boxOne night of dim light exposure and one night of bright light exposure. Lighting from the portable light box | Other | Lighting intervention |
Primary outcome
Pupil size
Time frame: 1 hour of pupillometry
Pupil size (mm) in response to pupillometry light stimuli using a pupillometry machine
1 secondary outcome
Dim Light Melatonin Onset (DLMO) from saliva
Time frame: 8 hours
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 8 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Elizabeth Klerman, MD PhD principal investigator
MGB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ocular light exposure from portable light box in people with Circadian Rhythm and Pupillometry, run by Elizabeth B Klerman MD PhD 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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 8 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. 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 Elizabeth Klerman, MD PhD (617-643-2424, MGB_OSCAR@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupil size (time frame: 1 hour of pupillometry). 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 8 Sep 2026.