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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorMassachusetts General Hospital

About this trial

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

This trial accepts healthy volunteers

Qualifiers

(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;

Disqualifiers

(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);

Trial design

Design model

Single group

Treatments tested in this trial

  • Pupillometry

    Device

    Pupillometer measurement of pupil size in response to different light stimuli

  • Light box exposure

    Device

    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)

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: Testing non-visual light impacts on pupil response, circadian timing, and hormonesExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pupil size

Pupil size as measured by pupillometry

Time frame
During pupillometry testing on Day 1 afternoon, Day 1 evening, Day 2 morning, Day 2 evening
2

Melatonin levels for circadian timing assessment

Melatonin levels from saliva collection during Night 1 light box red light exposure

Time frame
Night 1
3

Melatonin levels for hormone response

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

Time frame
Night 1 and Night 2

Secondary outcomes

Other outcomes

Sponsors and contacts

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