A Light Exposure Tracker Designed to Improve Circadian Rhythms - Aim 1

Mild Cognitive Impairment Clinical Trial

Official title:

Light Exposure Tracker in Alzheimer's Disease.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06356337
• Other study ID #: STUDY-22-01199
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: April 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Barbara Plitnick
• Phone: 518-242-4603
• Email: barbara.plitnick[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to investigate the relationship between light and circadian rhythms. Twenty healthy older adults will be recruited to participate in a randomized, cross-over study, where an active lighting intervention designed to maintain entrainment and a control intervention designed not to entrain will be tested.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Device:
• Light goggles
Blue light goggles designed to promote circadian entrainment will be worn for 1 hour each morning for two weeks.
• Orange glasses
Orange glasses that do not provide entrainment will be worn for 1 hour each morning to block morning light for two weeks.

Locations

Country	Name	City	State
United States	Light and Health Research Center	Menands	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Saliva samples for melatonin levels	Serial saliva samples will be collected to calculate dim light melatonin onset.	Baseline and 2-weeks post-intervention
Secondary	Light exposure using the Speck	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
Secondary	Sleep time using actigraphy	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