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

Normal Physiology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05829044
• Other study ID #: 2023P000904
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Normal Physiology

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