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

Sleep Quality Clinical Trial

Official title:

Filtered Eyewear to Prevent Light-induced Melatonin Suppression While Maintaining Visual Performance and Alertness in Night-shift Working Nurses - Aim 1

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06310135
• Other study ID #: STUDY-23-00816
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2024
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Mariana Figueiro, PhD
• Phone: 518-366-9306
• Email: Mariana.figueiro[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep Quality

Intervention

Device:
• 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.
• 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.

Other:
• No Filters
Dim lights with no filters.

Locations

Country	Name	City	State
United States	Light and Health Research Center	Menands	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Melatonin Levels	Melatonin levels to assess Melatonin Suppression. Saliva samples will be collected every 30 minutes for melatonin levels.	Each night for 6 study nights
Secondary	Karolinska Sleepiness scale to measure Subjective Sleepiness	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.	Each night for 6 study nights
Secondary	Numerical Verification Task (NVT)	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.	Each night for 6 study nights