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

Not Applicable

Recruiting

• Conditions: Alzheimer's Disease; Mild Cognitive Impairment
• Interventions: Device: Light goggles; Device: Orange glasses

• Registration Number: NCT06356337
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-22
• Status Verified: 2024-04
• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-04-04
• Last Update Submitted: 2024-04-04
• Study First Posted: 2024-04-10
• Last Update Posted: 2024-04-10
• Primary Completion: 2024-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Light Googles then Orange Glasses	Orange glasses	Participants use blue light goggles then cross over to orange glasses.
Light Googles then Orange Glasses	Light goggles	Participants use blue light goggles then cross over to orange glasses.
Orange Glasses then Light Googles	Light goggles	Participants use orange glasses then cross over to blue light goggles.
Orange Glasses then Light Googles	Orange glasses	Participants use orange glasses then cross over to blue light goggles.

Primary Outcome Measures

Name	Time	Method
Saliva samples for melatonin levels	Baseline and 2-weeks post-intervention	Serial saliva samples will be collected to calculate dim light melatonin onset.

Secondary Outcome Measures

Name	Time	Method
Light exposure using the Speck	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.
Sleep time using actigraphy	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.

Trial Locations

Locations (1)

Light and Health Research Center; 🇺🇸 Menands, New York, United States