NCT07753889

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
113mo left

Started Sep 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2026

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2034

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

8.3 years

First QC Date

March 17, 2026

Last Update Submit

August 6, 2026

Conditions

Keywords

Pupil (eye)LightCircadian RhythmsSleep

Outcome Measures

Primary Outcomes (1)

  • Pupil size

    Pupil size (mm) in response to pupillometry light stimuli using a pupillometry machine

    1 hour of pupillometry

Secondary Outcomes (1)

  • Dim Light Melatonin Onset (DLMO) from saliva

    8 hours

Other Outcomes (1)

  • Melatonin suppression

    8 hours on Night 1 (ocular dim light exposure) and 8 hours on Night 2 (ocular bright light exposure)

Study Arms (1)

Lighting intervention

EXPERIMENTAL

Pupillometry at MGH following by saliva collection during one night of dim light and then one night of bright light

Other: Ocular light exposure from portable light box

Interventions

One night of dim light exposure and one night of bright light exposure. Lighting from the portable light box

Lighting intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old.
  • stable medically
  • ability to speak, understand and read English at a high school level

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MassGeneralBrigham

Boston, Massachusetts, 02114, United States

RECRUITING

Study Officials

  • Elizabeth Klerman, MD PhD

    MGB

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Klerman, MD PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

March 17, 2026

First Posted

August 10, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2034

Study Completion (Estimated)

December 1, 2035

Last Updated

August 10, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations