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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05829044
Other study ID # 2023P000904
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date December 2026

Study information

Verified date December 2023
Source Massachusetts General Hospital
Contact Elizabeth B Klerman, MD PhD
Phone 617-643-2424
Email ebklerman@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date December 2026
Est. primary completion date September 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - (i) 18-85 years old. - (ii) Habitual sleep onset 10 pm- 1 am; - (iii) Habitual wake onset 5:30 am- 8:30 am; - (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; limited-duration counseling without prescription medications will not be exclusionary; (iv) current or history of circadian rhythm sleep-wake disorder; - (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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Pupillometry
Pupillometer measurement of pupil size in response to different light stimuli
Light box exposure
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)

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pupil size Pupil size as measured by pupillometry During pupillometry testing on Day 1 afternoon, Day 1 evening, Day 2 morning, Day 2 evening
Primary Melatonin levels for circadian timing assessment Melatonin levels from saliva collection during Night 1 light box red light exposure Night 1
Primary 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 Night 1 and Night 2
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