Filtered Eyewear for Sleep Quality

Overseen by Mariana Figueiro, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Melatonin, Beta blockers, Antidepressants

Disqualifiers: Bipolar, Diabetes, Hypertension, Cancer, others

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

Yes, you will need to stop taking melatonin supplements, beta blockers, sleep medications, and antidepressant medications to participate in this trial.

What data supports the effectiveness of the treatment Filtered Eyewear for improving sleep quality?

Research suggests that orange-tinted blue-light-blocking glasses may help support sleep-wake rhythms by limiting exposure to biologically active light in everyday lighting conditions. ^{1 2 3 4 5}

Is filtered eyewear safe for human use?

There is no specific safety data available for filtered eyewear or blue-light-blocking glasses in the provided research articles. ^{6 7 8 9 10}

How does the treatment of filtered eyewear for sleep quality differ from other treatments?

Filtered eyewear, like blue-light-blocking glasses, is unique because it aims to improve sleep quality by reducing exposure to blue light in the evening, which can disrupt the body's natural sleep-wake cycle. Unlike medications or other therapies, this treatment is non-invasive and involves wearing special glasses before bedtime to help support better sleep patterns. ^{2 3 5 11 12}

Research Team

Mariana Figueiro, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for night shift workers interested in how different types of eyewear might affect their sleep quality. Specific eligibility details are not provided, but typically participants would need to be healthy adults who work at night.

Inclusion Criteria

Healthy

Exclusion Criteria

History of bipolar disorder

I have experienced seasonal depression.

I have a history of diabetes.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Study Nights

Participants undergo six 5-hour study nights with different light exposure conditions to assess melatonin suppression, subjective sleepiness, and visual performance.

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the study nights

4 weeks

Treatment Details

Interventions

• Filtered Eyewear (Behavioural Intervention)

Trial Overview The study tests if wearing filtered eyewear that blocks blue light can prevent melatonin suppression and improve sleepiness and visual performance compared to unfiltered eyewear or no filters at all.

Participant Groups

Group I: Unfiltered Monocular Experimental Treatment 1 Intervention

Unfiltered monocular with the non-dominant eye occluded.

Group II: Unfiltered Binocular Experimental Treatment 1 Intervention

Unfiltered binocular - neither eye will be filtered.

Group III: Filtered Monocular Experimental Treatment 1 Intervention

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

Group IV: Filtered Binocular Experimental Treatment 1 Intervention

Filtered binocular with both eyes filtered.

Group V: Dim Light Control Placebo Group 1 Intervention

Dim light with no filters.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA

Findings from Research

Wearing blue-blocking lenses (BBLs) in the evening may not effectively improve sleep quality, as they can still allow some blue light to pass through, which can suppress melatonin production.

Different brands of BBLs vary significantly in their effectiveness at blocking blue light, with those that block the most blue light showing the least impact on nocturnal melatonin secretion, suggesting that not all BBLs are equally beneficial for maintaining a healthy circadian rhythm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modelling the effect of light through commercially available blue-blocking lenses on the human circadian system. Alzahrani, HS., Khuu, SK., Roy, M.[2022]

A study evaluated 50 commercial lenses designed to filter blue light, revealing that red-tinted lenses blocked the most circadian-proficient light, while reflective blue lenses allowed the most through.

Orange-tinted lenses provided a balance by blocking significant biologically active light while maintaining high transmission specificity, making them the most effective option for supporting healthy sleep-wake cycles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spectrophotometric properties of commercially available blue blockers across multiple lighting conditions. Mason, BJ., Tubbs, AS., Fernandez, FX., et al.[2023]

Adverse reactions to sunscreens are rare, primarily linked to organic UV filters, which can cause allergic and irritant contact dermatitis, while inorganic UV filters like zinc oxide and titanium dioxide are generally safe and do not cause significant skin irritation or sensitization.

The mechanism behind the adverse reactions is largely due to the small molecular size and lipophilic nature of organic UV filters, allowing them to penetrate the skin and potentially cause sensitization, unlike inorganic filters that work by reflecting and scattering UV rays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Reactions to Sunscreens. Ludriksone, L., Elsner, P.[2022]

Solar protection products (SPP) are effective against harmful solar radiation effects when used correctly, following guidelines from the French Medicines Agency, which emphasize proper application and reapplication.

Concerns about the safety of chemical filters, particularly regarding potential endocrine disruption, appear to be low under normal usage conditions, but ongoing assessments of mineral filters like titanium dioxide and zinc oxide in nanoparticle form are necessary to fully understand their safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Solar protection products: efficacy and risks]. Beani, JC.[2012]

A study of 50 sunscreen products revealed that benzophenone (BP) and its derivatives, particularly BP-3 (oxybenzone), are commonly found in these products, with BP-3 concentrations being significantly higher in oxybenzone-containing sunscreens compared to those labeled as 'oxybenzone-free'.

The dermal exposure doses of BP-3 and BP from certain products exceeded safety reference values, indicating potential health concerns related to the widespread use of these UV filters in sunscreens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Survey of 14 Benzophenone UV Filters in Sunscreen Products Marketed in the United States: Implications for Human Exposure. Li, ZM., Kannan, K.[2022]

A study of 183 pregnant women found that higher maternal exposure to the chemical UV filter 4-hydroxy-benzophenone (4-HBP) was linked to increased levels of thyroid hormones and growth factors, particularly in mothers carrying male fetuses.

Male infants born to mothers with moderate exposure to 4-HBP had significantly lower birth weights and smaller head and abdominal circumferences compared to those with lower exposure, suggesting potential risks to fetal growth associated with UV filter exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal exposure to UV filters: associations with maternal thyroid hormones, IGF-I/IGFBP3 and birth outcomes. Krause, M., Frederiksen, H., Sundberg, K., et al.[2020]

The study highlights that the combination and concentration of UV filters in sunscreens are crucial for their effectiveness, as measured by sun protection factor (SPF).

Most of the 16 UV filters approved by the FDA are deemed safe and effective based on extensive evaluations, and the benefits of using sunscreens outweigh potential health concerns, supporting their favorable benefit-to-risk ratio.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human safety and efficacy of ultraviolet filters and sunscreen products. Nash, JF.[2013]

Blue-light filtering spectacle lenses do not significantly reduce visual fatigue or improve critical flicker-fusion frequency compared to non-blue-light filtering lenses, based on a systematic review of 17 randomized controlled trials involving various adult populations.

There is likely little to no effect of blue-light filtering lenses on visual performance and sleep quality, with mixed results reported across studies, indicating a need for further high-quality research to clarify these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blue-light filtering spectacle lenses for visual performance, sleep, and macular health in adults. Singh, S., Keller, PR., Busija, L., et al.[2023]

Combining cognitive behavioral therapy for insomnia (CBT-I) with blue-light blocking glasses significantly reduced anxiety and depression symptoms in patients, with a notable reduction in the Beck Anxiety Inventory (BAI) score in the active group compared to the placebo group.

Patients using blue-light blocking glasses also experienced a significant increase in subjective total sleep time and a reduction in sleep latency, suggesting that blocking blue light before bedtime can enhance sleep quality for those with insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Block the light and sleep well: Evening blue light filtration as a part of cognitive behavioral therapy for insomnia. Janků, K., Šmotek, M., Fárková, E., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of a blue-light-blocking intraocular lens on the quality of sleep. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Modelling the effect of light through commercially available blue-blocking lenses on the human circadian system. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Blue-Light Filtering Spectacle Lenses: Optical and Clinical Performances. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Blue-light-blocking intraocular lens implantation improves the sleep quality of cataract patients. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Spectrophotometric properties of commercially available blue blockers across multiple lighting conditions. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Reactions to Sunscreens. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Solar protection products: efficacy and risks]. [2012]

8. United States pubmed.ncbi.nlm.nih.gov

Comprehensive Survey of 14 Benzophenone UV Filters in Sunscreen Products Marketed in the United States: Implications for Human Exposure. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Maternal exposure to UV filters: associations with maternal thyroid hormones, IGF-I/IGFBP3 and birth outcomes. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Human safety and efficacy of ultraviolet filters and sunscreen products. [2013]

11. England pubmed.ncbi.nlm.nih.gov

Blue-light filtering spectacle lenses for visual performance, sleep, and macular health in adults. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Block the light and sleep well: Evening blue light filtration as a part of cognitive behavioral therapy for insomnia. [2022]