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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06310135
Enrollment
29
Registered
2024-03-15
Start date
2024-05-01
Completion date
2024-10-31
Last updated
2025-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Quality

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.

Interventions

DEVICEFiltered 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.

DEVICEUnfiltered 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.

OTHERNo Filters

Dim lights with no filters.

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Melatonin Levels AUCEach night for 6 study nightsMelatonin levels to assess Melatonin Suppression. Saliva samples will be collected every 30 minutes for melatonin levels.

Secondary

MeasureTime frameDescription
Karolinska Sleepiness scale to measure Subjective SleepinessEach night for 6 study nightsSubjective 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 nightsThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026