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Light Exposure for Sleep and Circadian Rhythms
N/A
Recruiting
Led By Elizabeth B Klerman, MD PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
(i) 18-85 years old.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during pupillometry testing on day 1 afternoon, day 1 evening, day 2 morning, day 2 evening
Awards & highlights
No Placebo-Only Group
Summary
This trial tests how the eye's pupil responds to light, and how that relates to sleep and daily rhythms in people of different ages. Participants wear a watch, have an eye exam and complete questionnaires before staying in a research room for testing.
Who is the study for?
This trial is for healthy individuals aged 18-85 with a normal sleep schedule (bedtime between 10 pm and 1 am, wake time between 5:30 am and 8:30 am), vision correctable to at least 20/30, and no major medical issues.
What is being tested?
The study examines how pupil response to light varies by age and sex, and its relationship with sleep patterns, circadian rhythms, and hormone responses. Participants will undergo eye exams using pupillometry and be exposed to a light box while staying in a research facility.
What are the potential side effects?
There are minimal side effects expected from this trial as it involves non-invasive procedures like pupillometry (eye exam) and exposure to light boxes designed for the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 85 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during pupillometry testing on day 1 afternoon, day 1 evening, day 2 morning, day 2 evening
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during pupillometry testing on day 1 afternoon, day 1 evening, day 2 morning, day 2 evening
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Melatonin levels for circadian timing assessment
Melatonin levels for hormone response
Pupil size
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Testing non-visual light impacts on pupil response, circadian timing, and hormonesExperimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pupillometry
2017
Completed Phase 1
~330
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,763 Total Patients Enrolled
Elizabeth B Klerman, MD PhDPrincipal InvestigatorMass. General Hospital
8 Previous Clinical Trials
994 Total Patients Enrolled