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

ConditionsCircadian Rhythm Pupillometry Sleep

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-85

SponsorElizabeth B Klerman MD PhD

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18-85 years old.

stable medically

ability to speak, understand and read English at a high school level

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: Lighting interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Pupil size

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

Time frame

1 hour of pupillometry

Secondary outcomes

Dim Light Melatonin Onset (DLMO) from saliva

Dim Light Melatonin Onset (DLMO) calculated from salivary melatonin collected during night of ocular dim light exposure

Time frame

8 hours

Other outcomes

Melatonin suppression

Melatonin concentration Area Under the Curve (AUC) on Night2/Night1

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Elizabeth B Klerman MD PhD

Lead sponsor

Massachusetts General Hospital

Sponsor institution

Massachusetts General Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: