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

Mount Sinai Health System

Status: Completed

Conditions: Sleep Quality

Treatments: Device: Filtered Eyewear; Other: No Filters; Device: Unfiltered Eyewear

Study type: Interventional

Funder types: Other

Identifiers

NCT06310135

STUDY-23-00816

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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29 participants in 5 patient groups, including a placebo group

Unfiltered Monocular

Experimental group

Description:

Unfiltered monocular with the non-dominant eye occluded.

Treatment:

Device: Unfiltered Eyewear

Filtered Binocular

Experimental group

Description:

Filtered binocular with both eyes filtered.

Treatment:

Device: Filtered Eyewear

Filtered Monocular

Experimental group

Description:

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

Treatment:

Device: Filtered Eyewear

Unfiltered Binocular

Experimental group

Description:

Unfiltered binocular - neither eye will be filtered.

Treatment:

Device: Unfiltered Eyewear

Dim Light Control

Placebo Comparator group

Description:

Dim light with no filters.

Treatment:

Other: No Filters