RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-12-01
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05829044

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * (i) 18-85 years old.
  2. * (ii) Habitual sleep onset 10 pm- 1 am;
  3. * (iii) Habitual wake onset 5:30 am- 8:30 am;
  4. * (iv) vision correctable to 20/30;
  5. * (v) stable medically.
  6. * (vi) ability to speak, understand, and read English at a high school level
  1. * (i) Color blind by Ishihara Color Blindness Test;
  2. * (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)
  3. * (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;
  4. * (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);
  5. * (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;
  6. * (vii) shift- or night-work in past three months; history of night work in preceding 3 year period
  7. * (viii) crossing more than 2 time zones in past three months;
  8. * (ix) presence of depression as assessed by a Beck Depression Inventory (BDI) score \>14.
  9. * (x) pregnant or less than 6 weeks post-partum or breast-feeding

Contacts and Locations

Study Contact

Elizabeth B Klerman, MD PhD
CONTACT
617-643-2424
ebklerman@mgh.harvard.edu

Principal Investigator

Elizabeth B Klerman, MD PhD
PRINCIPAL_INVESTIGATOR
Mass. General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Elizabeth B Klerman, MD PhD, PRINCIPAL_INVESTIGATOR, Mass. General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-01
Study Completion Date2026-12

Study Record Updates

Study Start Date2023-12-01
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • eye pupil response
  • circadian rhythms
  • light
  • melatonin

Additional Relevant MeSH Terms

  • Normal Physiology