Relationships Among Pupil Responses to Light, Circadian Rhythms, and Sleep

NCT07753889 — Not applicable, Not yet recruiting, 100 participants, Elizabeth B Klerman MD PhD

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Documenting Relationships Among Pupil Responses to Light, Circadian Rhythms, and Sleep in Healthy People and Those With Disorders or Disease

Registry	NCT07753889, acronym SCOPE
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, basic science
Enrollment	100 (Estimated)
Sponsor	Elizabeth B Klerman MD PhD (Other); collaborators: Massachusetts General Hospital
Conditions	Circadian Rhythm, Pupillometry, Sleep
Interventions	Ocular light exposure from portable light box (Other)
Dates	start 2027-09-01 (estimated), primary completion 2034-12-01 (estimated), completion 2035-12-01 (estimated), first posted 2026-08-10, last updated 2026-09-08
Locations	1 site in United States

-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.

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Lighting intervention	Experimental	Other: Ocular light exposure from portable light box	Pupillometry at MGH following by saliva collection during one night of dim light and then one night of bright light

Ocular light exposure from portable light box (Other): One night of dim light exposure and one night of bright light exposure. Lighting from the portable light box

+Outcome measures

Primary outcomes

Pupil size [1 hour of pupillometry]: Pupil size (mm) in response to pupillometry light stimuli using a pupillometry machine

Secondary outcomes

Dim Light Melatonin Onset (DLMO) from saliva [8 hours]: Dim Light Melatonin Onset (DLMO) calculated from salivary melatonin collected during night of ocular dim light exposure

Other outcomes

Melatonin suppression [8 hours on Night 1 (ocular dim light exposure) and 8 hours on Night 2 (ocular bright light exposure)]: Melatonin concentration Area Under the Curve (AUC) on Night2/Night1

+Eligibility

Sex: All, ages: 18 Years to 85 Years, accepts healthy volunteers

Inclusion Criteria:

* 18-85 years old.
* stable medically
* ability to speak, understand and read English at a high school level

Exclusion Criteria:

* 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.

+Locations (1)

Facility	City	Country	Status
MassGeneralBrigham	Boston, Massachusetts	United States

+Investigators

Elizabeth Klerman, MD PhD, Principal investigator, MGB