RecruitingNot Applicable

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

United States48 participantsStarted 2023-12-01

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 o…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pupil size

Timeframe: During pupillometry testing on Day 1 afternoon, Day 1 evening, Day 2 morning, Day 2 evening

Melatonin levels for circadian timing assessment

Timeframe: Night 1

Melatonin levels for hormone response

Timeframe: Night 1 and Night 2

Trial details

NCT IDNCT05829044

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Elizabeth B Klerman, MD PhD

617-643-2424 ebklerman@mgh.harvard.edu

View on ClinicalTrials.gov More Normal Physiology trials