Impact of Sex and Age on Non-visual Light Input That Affects Sleep and Circadian Rhythms

Phase

N/A

Condition

N/A

Treatment

Light box exposure

Melatonin Suppression Test

Pupillometry

Clinical Study ID

NCT05829044

2023P000904

Ages 18-85
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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, orany type of blindness) besides correctable vision abnormalities (e.g., withglasses); any abnormalities on clinical eye exam (e.g., neuritis, Neuromyelitisoptica, treated or untreated glaucoma) such that the ophthalmologist recommends theparticipant not be studied; Limited cataracts (e.g., Lens Opacities Classification (LOCS) III grade <2) will be allowed and documented during the eye exam. Eye dropsthat affect pupil size or contractility (e.g. mydriatics, miotics); drops to treatglaucoma (e.g., pilocarpine, brimonidine, other drops like artificial tear drops, oranti-inflammatory drops would not be exclusionary)
(iii) current or history of neurologic or psychiatric disease including autonomicfunction disorder or migraines; psychiatric disorder requiring medications in afirst degree relative (healthy controls only); limited-duration counseling withoutprescription medications will not be exclusionary; (iv) current or history ofcircadian rhythm sleep-wake disorder (healthy controls only);
(v) prescription or non-prescription drugs affecting the pupil (e.g., affectingautonomic function), sleep, melatonin (e.g., lithium, alpha- and beta-adrenergicantagonists), and/or circadian rhythms (e.g., beta blockers, non-steroidalanti-inflammatory drugs, tricyclics);
(vi) Other disorders that can affect or may be affected by intrinsicallyphotosensitive 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

Study Design

Light box exposure

December 01, 2023

June 30, 2026

Connect with a study center

Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Active - Recruiting

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