- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06356337
A Light Exposure Tracker Designed to Improve Circadian Rhythms - Aim 1
October 9, 2025 updated by: Mariana Figueiro, Icahn School of Medicine at Mount Sinai
Light Exposure Tracker in Alzheimer's Disease.
The purpose of this research study is to investigate the relationship between reminder messages sent via text and compliance with a daily morning light intervention designed to advance the circadian clock.
Twenty healthy adults will be recruited to participate in a randomized, cross-over study where daily messages are, or are not, provided to remind participants to carry out the intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Menands, New York, United States, 12204
- Light and Health Research Center
-
-
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.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- healthy adults over the age of 55
- score of 25 or greater on MoCA
Exclusion Criteria:
- Severe sleep apnea
- restless leg syndrome
- obstructing cataracts
- macular degeneration
- diabetic retinopathy
- glaucoma
- use of sleep medications
- brain disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Light Googles plus reminder text messages
Participants use green light goggles for one hour each morning for two consecutive weeks and also receive a daily text message reminding them to wear the light goggles
|
Green light goggles worn for 1 hour each morning for two weeks
Participants will receive daily text message reminding them to use light goggles each morning
|
|
Experimental: Light Goggles alone
Participants use green light goggles for one hour each morning for two consecutive weeks
|
Green light goggles worn for 1 hour each morning for two weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Saliva samples for melatonin levels
Time Frame: Baseline and 2-weeks post-intervention for each Arm
|
Serial saliva samples will be collected to calculate dim light melatonin onset.
|
Baseline and 2-weeks post-intervention for each Arm
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Light exposure using the Speck
Time Frame: worn all 12 study weeks
|
The Speck light meter will be used to collect overall light exposure.The Speck light meter uses a photosensor to measure the amount of light study participants are exposed to each day.
|
worn all 12 study weeks
|
|
Sleep time using actigraphy
Time Frame: worn all 12 study weeks
|
Sleep time will be calculated from the actigraph.
The wrist actigraph measures activity during the day and how well you sleep at night.
The actigraph software will calculate the amount of time spent in bed sleeping.
|
worn all 12 study weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mariana Figueiro, PhD, Ichan School of Medicine
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 Major Dates
Study Start (Actual)
February 22, 2024
Primary Completion (Actual)
August 15, 2024
Study Completion (Actual)
August 15, 2024
Study Registration Dates
First Submitted
April 4, 2024
First Submitted That Met QC Criteria
April 4, 2024
First Posted (Actual)
April 10, 2024
Study Record Updates
Last Update Posted (Estimated)
October 14, 2025
Last Update Submitted That Met QC Criteria
October 9, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY-22-01199
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
overall study results will be shared not individual.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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