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NCT Number: NCT05829044

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

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.

Recruiting

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Elizabeth Klerman, MD PhD

CONTACT

[email protected]

857-507-0765

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Pupil size

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

    Pupil size as measured by pupillometry

  2. Melatonin levels for circadian timing assessment

    Time frame: Night 1

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

  3. Melatonin levels for hormone response

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth B Klerman, MD PhD

CONTACT

[email protected]

617-643-2424

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 25, 2023
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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