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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05829044
Status
Recruiting
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Conditions

  • Normal Physiology

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • 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)

Study Details

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.

Key Dates

Start date
Dec 1, 2023
Status verified
Apr 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Testing non-visual light impacts on pupil response, circadian timing, and hormones
    1. Pupillometry on day 1 in afternoon and evening and on day 2 in morning and evening. Participants will be randomized to one of 8 different light stimuli within the pupillometry 2. Red light exposure on night 1 to determine circadian timing 3. Blue/green light exposure on night 2 to compare hormone response during blue/green light to that during red light on night 1

Primary Outcome Measure

Pupil size [ Time Frame: During pupillometry testing on Day 1 afternoon, Day 1 evening, Day 2 morning, Day 2 evening ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Elizabeth Klerman, MD PhD
[email protected]
857-507-0765

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By research site
Massachusetts General Hospital· Boston, MA

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