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

Обзор

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.

Вмешательства

• Устройство Pupillometry
  Pupillometer measurement of pupil size in response to different light stimuli
• Устройство 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)

Первичные конечные точки

• Pupil size [Срок оценки: During pupillometry testing on Day 1 afternoon, Day 1 evening, Day 2 morning, Day 2 evening]
• Melatonin levels for circadian timing assessment [Срок оценки: Night 1]
• Melatonin levels for hormone response [Срок оценки: Night 1 and Night 2]

Критерии участия

Критерии включения

• (i) 18-85 years old.
• (ii) Habitual sleep onset 10 pm- 1 am (healthy controls only);
• (iii) Habitual wake onset 5:30 am- 8:30 am (healthy controls only);
• (iv) vision correctable to 20/30;
• (v) stable medically.
• (vi) ability to speak, understand, and read English at a high school level

Критерии исключения

• (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 (healthy controls only); limited-duration counseling without prescription medications will not be exclusionary; (iv) current or history of circadian rhythm sleep-wake disorder (healthy controls only);
• (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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT05829044 · 2023P000904

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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