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

Not Applicable

Completed

• Conditions: Sleep Quality
• Interventions: Device: Unfiltered Eyewear; Device: Filtered Eyewear; Other: No Filters

• Registration Number: NCT06310135
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-15
• Study Start: 2024-05-01
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Unfiltered Binocular	Unfiltered Eyewear	Unfiltered binocular - neither eye will be filtered.
Filtered Monocular	Filtered Eyewear	Filtered monocular with non-dominant eye filtered, the other non-filtered.
Dim Light Control	No Filters	Dim light with no filters.
Unfiltered Monocular	Unfiltered Eyewear	Unfiltered monocular with the non-dominant eye occluded.
Filtered Binocular	Filtered Eyewear	Filtered binocular with both eyes filtered.

Primary Outcome Measures

Name	Time	Method
Melatonin Levels	Each night for 6 study nights	Melatonin levels to assess Melatonin Suppression. Saliva samples will be collected every 30 minutes for melatonin levels.

Secondary Outcome Measures

Name	Time	Method
Karolinska Sleepiness scale to measure Subjective Sleepiness	Each night for 6 study nights	Subjective sleepiness will be measured using the Karolinska Sleepiness scale. This 9-point scale scores range from 1-9, where 1 = "very alert," 3 = "alert," 5 = "neither alert nor sleepy," 7 = "sleepy, but no difficulty remaining awake," and 9 = "very sleepy, fighting sleep, an effort to remain awake." Full scale from 1-9. A higher number indicates greater sleepiness.
Numerical Verification Task (NVT)	Each night for 6 study nights	The NVT requires participants to compare 2 lists of 20 pairs of 5-digit numerals at 2 contrasts (0.2 and 0.8), and the response time required to complete the task is recorded as the performance measure. A faster response time indicates better visual performance.

Trial Locations

Locations (1)

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