Filtered Eyewear to Prevent Light-induced Melatonin Suppression - Aim 1

NCT06310135 | Completed

• 1 other identifier: STUDY-23-00816
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the relative effectiveness of monocular and binocular light exposures, with and without selective blue-blocking filtering, on nocturnal melatonin suppression, subjective sleepiness, and visual performance of night shift workers.

Conditions

Sleep Quality

Outcome Measures

Primary Outcomes (1)

• Melatonin Levels AUC

  Melatonin levels to assess Melatonin Suppression. Saliva samples will be collected every 30 minutes for melatonin levels.

  Each night for 6 study nights

Secondary Outcomes (2)

• Karolinska Sleepiness scale to measure Subjective Sleepiness

  Each night for 6 study nights

• Numerical Verification Task (NVT)

  Each night for 6 study nights

Study Arms (5)

Unfiltered Monocular

EXPERIMENTAL

Unfiltered monocular with the non-dominant eye occluded.

Device: Unfiltered Eyewear

Filtered Binocular

EXPERIMENTAL

Filtered binocular with both eyes filtered.

Device: Filtered Eyewear

Filtered Monocular

EXPERIMENTAL

Filtered monocular with non-dominant eye filtered, the other non-filtered.

Device: Filtered Eyewear

Unfiltered Binocular

EXPERIMENTAL

Unfiltered binocular - neither eye will be filtered.

Device: Unfiltered Eyewear

Dim Light Control

PLACEBO COMPARATOR

Dim light with no filters.

Other: No Filters

Interventions

Filtered Eyewear DEVICE

Filtered binocular viewing condition will be produced by eyeglasses frames with orange-tinted blue-blocking filter, eliminating all optical radiation for wavelengths shorter than 540 nm. For the filtered monocular condition, only the lens on the eyeglasses frame on the non-dominant eye will be tinted with the blue-blocking filter.

Filtered Binocular; Filtered Monocular

Unfiltered Eyewear DEVICE

For the unfiltered binocular, the subjects will wear transparent eyeglasses frames with no optical power. Unfiltered monocular vision will be produced by an opaque eyepatch occluding the non-dominant eye.

Unfiltered Binocular; Unfiltered Monocular

No Filters OTHER

Dim lights with no filters.

Dim Light Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy

You may not qualify if:

• Bipolar disorder
• Seasonal depression
• Diabetes
• High blood pressure
• History of cancer
• Obstructing cataracts
• Macular degeneration
• Diabetic retinopathy
• Glaucoma
• Use of melatonin supplements
• Use of beta blockers
• Use of sleep medications
• Use of antidepressant medication

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Light and Health Research Center

Menands, New York, 12204, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Mariana Figueiro

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 15, 2024
• Study Start: May 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)