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Testing non-visual light impacts on pupil response, circadian timing, and hormones for Normal Physiology

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

Study 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.Check my eligibility

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.See study design

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and during pupillometry testing on day 1 afternoon, day 1 evening, day 2 morning, day 2 evening for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Melatonin levels for circadian timing assessment

Melatonin levels for hormone response

Pupil size

Trial Design

1Treatment groups

Experimental Treatment

Group I: Testing non-visual light impacts on pupil response, circadian timing, and hormonesExperimental Treatment2 Interventions

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 Red light exposure on night 1 to determine circadian timing 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,935 Previous Clinical Trials

13,198,593 Total Patients Enrolled

Elizabeth B Klerman, MD PhDPrincipal InvestigatorMass. General Hospital

8 Previous Clinical Trials

994 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the upper age limit for enrolment in this investigation set at 65 years of age?

"This study is accepting participants who are aged 18 or above and younger than 85."

Answered by AI

How large is the total cohort for this research endeavor?

"Indeed, clinicaltrials.gov confirm that this study is currently recruiting patients. This trial was first introduced on December 1st 2023 and most recently updated on the 4th of same month. 48 participants are being sought out from a single medical centre."

Answered by AI

Are participants currently being enrolled into this investigation?

"The medical trial is still enrolling participants as evidenced by the information available on clinicaltrials.gov; it was initiated on December 1st 2023, and its listing has been updated most recently on December 4th 2023."

Answered by AI

What are the eligibility requirements for participation in this clinical trial?

"This study requires 48 volunteers, aged 18 to 85, with no current medical complications and a habitual sleep-wake cycle ranging from 10pm to 1am for sleep onset and 5:30am to 8:30am for wake onset. All participants must have vision correctable up to 20/20."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Elizabeth B Klerman MD PhD 2023. "Impact of Sex and Age on Non-visual Light Input That Affects Sleep and Circadian Rhythms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05829044.

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