Normal Physiology
Conditions
Keywords
eye pupil response, circadian rhythms, light, melatonin
Brief summary
The goal of this clinical trial is to learn how the pupil responds to different light stimuli and how that relates to sleep and daily rhythms in healthy people of different ages. The main questions it aims to answer are: * Does the eye's pupil response to light stimuli differ by the sex and age of the participant? * Is the eye's pupil response to light stimuli related to each participant's sleep timing, their body clock timing, and their hormone responses to light. Participants will have a special eye exam and complete questionnaires before starting the study to see if they can participate. If they can participate, they will wear a special watch that monitors their activity and light levels for one week. Then they will live in a research room at the Mass General Hospital for 3 days/2 nights during which we will test their pupil response to light, their body clock timing, and their hormone responses to light.
Interventions
DEVICEPupillometry
Pupillometer measurement of pupil size in response to different light stimuli
DEVICELight box exposure
Using a light box to produce different wavelengths and intensities of light. Exposure to red light on Night 1 and blue/green light on Night 2 to determine circadian timing and suppression of hormone (melatonin)
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
All participants will have the same study conditions and schedule except for the order combinations of light stimuli within the pupillometer testing. There are 8 different order combinations of light stimuli. Participants will be randomized to one of those combinations.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* (i) 18-85 years old. * (ii) Habitual sleep onset 10 pm- 1 am (healthy controls only); * (iii) Habitual wake onset 5:30 am- 8:30 am (healthy controls only); * (iv) vision correctable to 20/30; * (v) stable medically. * (vi) ability to speak, understand, and read English at a high school level
Exclusion criteria
* (i) Color blind by Ishihara Color Blindness Test; * (ii) any history of eye trauma, surgery or abnormality (e.g., retinopathy, glaucoma, cataracts, amblyopia, macular degeneration, congenital color vision deficiencies, or any type of blindness) besides correctable vision abnormalities (e.g., with glasses); any abnormalities on clinical eye exam (e.g., neuritis, Neuromyelitis optica, treated or untreated glaucoma) such that the ophthalmologist recommends the participant not be studied; Limited cataracts (e.g., Lens Opacities Classification (LOCS) III grade \<2) will be allowed and documented during the eye exam. Eye drops that affect pupil size or contractility (e.g. mydriatics, miotics); drops to treat glaucoma (e.g., pilocarpine, brimonidine, other drops like artificial tear drops, or anti-inflammatory drops would not be exclusionary) * (iii) current or history of neurologic or psychiatric disease including autonomic function disorder or migraines; psychiatric disorder requiring medications in a first degree relative (healthy controls only); limited-duration counseling without prescription medications will not be exclusionary; (iv) current or history of circadian rhythm sleep-wake disorder (healthy controls only); * (v) 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); * (vi) Other disorders that can affect or may be affected by intrinsically photosensitive Retinal Ganglion Cell (ipRGC) function, including diabetes mellitus, multiple sclerosis, Parkinson's disease, seasonal affective disorder; * (vii) shift- or night-work in past three months; history of night work in preceding 3 year period * (viii) crossing more than 2 time zones in past three months; * (ix) presence of depression as assessed by a Beck Depression Inventory (BDI) score \>14. * (x) pregnant or less than 6 weeks post-partum or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pupil size | During pupillometry testing on Day 1 afternoon, Day 1 evening, Day 2 morning, Day 2 evening | Pupil size as measured by pupillometry |
| Melatonin levels for circadian timing assessment | Night 1 | Melatonin levels from saliva collection during Night 1 light box red light exposure |
| Melatonin levels for hormone response | Night 1 and Night 2 | Melatonin levels from saliva collection during Night 2 light box blue/green light exposure compared to those during Night 1 light box red light exposure |
Countries
United States
Contacts
CONTACTElizabeth B Klerman, MD PhD
PRINCIPAL_INVESTIGATORElizabeth B Klerman, MD PhD
Massachusetts General Hospital
Outcome results
None listed