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

NCT ID: NCT06310135

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-10-31

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.

Detailed Description

Over the course of six, 5-hour study nights, 30 participants will be randomized to 6 study conditions, 1) binocular dim-light control unfiltered, (2) monocular dim-light control (one eye occluded), (3) unfiltered binocular, (4) unfiltered monocular (non-dominant eye occluded), (5) filtered binocular (both eyes filtered), (6) filtered monocular (non-dominant eye filtered, the other non-filtered). Saliva samples will be collected every 30 minutes for melatonin levels. Participants will also be asked to provide subjective sleepiness and visual performance will be assessed. Study nights will be separated by one week and each participant will be randomized to one of the six study conditions each night. All participants will see all conditions.

Conditions

Sleep Quality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Unfiltered Monocular

Unfiltered monocular with the non-dominant eye occluded.

Group Type: EXPERIMENTAL

Unfiltered Eyewear

Intervention Type: 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.

Filtered Binocular

Filtered binocular with both eyes filtered.

Group Type: EXPERIMENTAL

Filtered Eyewear

Intervention Type: 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 Monocular

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

Group Type: EXPERIMENTAL

Filtered Eyewear

Intervention Type: 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.

Unfiltered Binocular

Unfiltered binocular - neither eye will be filtered.

Group Type: EXPERIMENTAL

Unfiltered Eyewear

Intervention Type: 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.

Dim Light Control

Dim light with no filters.

Group Type: PLACEBO_COMPARATOR

No Filters

Intervention Type: OTHER

Dim lights with no filters.

Interventions

Filtered Eyewear

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.

Intervention Type: DEVICE

Unfiltered Eyewear

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.

Intervention Type: DEVICE

No Filters

Dim lights with no filters.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Mariana Figueiro

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariana Figueiro

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Light and Health Research Center

Menands, New York, United States

Countries

United States

Other Identifiers

STUDY-23-00816

Identifier Type: -

Identifier Source: org_study_id