Impact of Sex and Age on Non-visual Light Input That Affects Sleep and Circadian Rhythms
Study Details
Study Description
Brief 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:
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Does pupil response to light stimuli differ by the sex and age of the participant?
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Is a participant's pupil response to light stimuli related to their sleep patterns, 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Light stimulus condition Different combinations of light stimuli order |
Device: Pupillometry
Pupillometer measurement of pupil size in response to different light stimuli
Device: Melatonin Suppression Test
Exposure to dim light on night1 and bright light on night2 to determine suppression of melatonin
|
Outcome Measures
Primary Outcome Measures
- Pupil size [4 measurements during inpatient stay (3 days)]
Pupil size as measured by pupillometry
- Melatonin Suppression Test [During inpatient stay (3 days)]
Suppression of hormone melatonin by light
Eligibility Criteria
Criteria
Inclusion Criteria:
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(i) 18-85 years old.
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(ii) Habitual sleep onset 10 pm- 1 am;
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(iii) Habitual wake onset 5:30 am- 8:30 am;
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(iv) vision correctable to 20/30;
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(v) stable medically.
Exclusion Criteria:
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(i) Color blind by Ishihara Color Blindness Test;
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(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)
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(iii) current or history of neurologic or psychiatric disease including autonomic function disorder; 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;
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(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);
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(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;
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(vii) shift- or night-work in past three months;
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(viii) crossing more than 2 time zones in past three months;
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(ix) presence of depression as assessed by a Beck Depression Inventory (BDI) score
- (x) pregnant or less than 6 weeks post-partum
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
- Principal Investigator: Elizabeth B Klerman, MD PhD, Mass. General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023P000904