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Clinical Trials/NCT06356337
NCT06356337CompletedNot Applicable

Light Exposure Tracker in Alzheimer's Disease.

Icahn School of Medicine at Mount Sinai1 site in 1 country20 target enrollmentStarted: February 22, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Saliva samples for melatonin levels

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
55 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • •use of sleep medications
  • •brain disease

Arms & Interventions

Light Googles plus reminder text messages

Active Comparator

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

Intervention: Light goggles (Device)

Light Googles plus reminder text messages

Active Comparator

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

Intervention: Daily reminder test message (Behavioral)

Light Goggles alone

Experimental

Participants use green light goggles for one hour each morning for two consecutive weeks

Intervention: Light goggles (Device)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Light exposure using the Speck(worn all 12 study weeks)
  • Sleep time using actigraphy(worn all 12 study weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mariana Figueiro

Professor

Icahn School of Medicine at Mount Sinai

Study Sites (1)

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