Filtered Eyewear for Sleep Quality

Overseen By Mark Rea, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

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 This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of glasses, including those that block blue light, might help night shift workers sleep better and feel less tired. It examines glasses that filter light in one or both eyes and compares them to normal glasses and dim light. The goal is to determine if these glasses, such as filtered eyewear (also known as blue-light-blocking glasses or selective blue-blocker eyewear), can improve sleep quality by reducing melatonin suppression, the hormone that aids sleep. Suitable candidates for this trial are healthy night shift workers without conditions like diabetes or high blood pressure and who do not use sleep or mood-related medications. As an unphased trial, this study offers participants the chance to contribute to innovative research that may enhance sleep quality for 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that blue-light filtering glasses, like those used in this trial, have not significantly improved vision or sleep quality. Some studies suggest these glasses do not reduce short-term eyestrain or noticeably enhance sleep.

However, no safety issues are known with wearing blue-light blocking glasses. They are generally considered safe. Since this trial is in the "Not Applicable" phase, it likely focuses on the effectiveness of the glasses rather than their safety, indicating that past research has not identified any major risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the filtered eyewear being tested for sleep quality improvement because it offers a non-invasive, drug-free alternative to traditional sleep aids like medications or supplements. Unlike standard treatments that often rely on chemical interventions, this eyewear uses specialized filters to manage light exposure, which can help regulate sleep patterns. This method is promising because it targets the body's natural circadian rhythms directly, potentially improving sleep without the side effects associated with medication. The trial includes different types of eyewear, such as filtered monocular and binocular options, each designed to see if specific light filtering can enhance sleep quality. This could pave the way for personalized sleep solutions tailored to individual needs.

What evidence suggests that this trial's treatments could be effective for improving sleep quality?

Research has shown that blue-light filtering glasses might help some people sleep better. In several studies, about half of the participants reported improved sleep when wearing these glasses before bed. However, other studies found no noticeable changes in sleep quality. This trial will evaluate different types of eyewear, including Filtered Monocular, Unfiltered Binocular, Unfiltered Monocular, Filtered Binocular, and a Dim Light Control. The effectiveness of these glasses seems to depend on their usage and the type of blue light they block. While there is potential, the results are mixed, and more research is needed to determine who benefits the most from using these glasses. ^{6 7 8 9 10}

Who Is on the Research Team?

Mariana Figueiro, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Filtered Eyewear

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Blue-light filtering spectacle lenses can reduce phototoxicity from blue light by 10.6% to 23.6% without significantly affecting visual performance, as shown in a study with 80 computer users.

Despite a slight decrease in scotopic sensitivity and melatonin suppression, over 70% of participants did not notice any changes in their vision, indicating that these lenses can be a safe option for retinal protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blue-Light Filtering Spectacle Lenses: Optical and Clinical Performances. Leung, TW., Li, RW., Kee, CS.[2019]

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]

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]

In a study of 49 patients aged around 80 years who had cataract surgery, the implantation of blue-light-blocking intraocular lenses (IOLs) did not significantly improve sleep quality compared to conventional IOLs, as measured by the Pittsburgh Sleep Quality Index.

The results suggest that blue-light-blocking IOLs can be used as an alternative to conventional IOLs without negatively impacting patients' sleep or circadian rhythms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a blue-light-blocking intraocular lens on the quality of sleep. Landers, JA., Tamblyn, D., Perriam, D.[2015]

In a study of 40 cataract patients, implantation of blue-light-blocking intraocular lenses significantly improved sleep quality, as measured by the Pittsburgh Sleep Quality Index, with median scores dropping from 7 before surgery to 4 after surgery.

The surgery also led to notable improvements in subjective sleep quality, sleep duration, and reduced daytime dysfunction, with a significant decrease in the number of poor sleepers after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blue-light-blocking intraocular lens implantation improves the sleep quality of cataract patients. Wei, X., She, C., Chen, D., et al.[2021]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37593770/

Blue-light filtering spectacle lenses for visual performance, ... Inconsistent findings were evident across six RCTs (148 participants); three studies reported a significant improvement in sleep scores with ...

2. tvst.arvojournals.org tvst.arvojournals.org/article.aspx?articleid=2810600

Optimizing the Potential Utility of Blue-Blocking Glasses for ... Conclusions: The efficacy of blue-blocking glasses depends on both spectral filtering and proper usage. The mDFD metric offers a consistent, ...

3. westbrowardeyecare.com westbrowardeyecare.com/blue-light-protection-what-the-evidence-shows/

Blue Light Protection: What the Evidence Shows Can blue light blocking lenses improve sleep quality? Studies suggest blue light glasses may help with sleep when worn 1-2 hours before bedtime.

4. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013244.pub2/full

Blue‐light filtering spectacle lenses for visual performance ... Six trials assessed outcomes related to subjective sleep quality ... data reported no significant difference in subjective sleep quality ...

5. scientificamerican.com scientificamerican.com/article/do-blue-light-glasses-help-with-eyestrain/

Do Blue-Light Glasses Help with Eyestrain? Three of the studies reported a significant improvement in sleep quality with blue-light-filtering lenses, while the other three reported no ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12315928/

Optimizing the Potential Utility of Blue-Blocking Glasses for ... Recent work suggests caution should be taken when evaluating the efficacy of blue-blocking glasses. One literature review has questioned the ...

7. mayoclinichealthsystem.org mayoclinichealthsystem.org/hometown-health/speaking-of-health/are-blue-light-blocking-glasses-a-must-have

Are blue light-blocking glasses a must-have? No significant improvement in vision performance or sleep quality has been found from using blue-blocking lenses.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10436683/

Blue‐light filtering spectacle lenses for visual performance ... Blue-light filtering lenses may not reduce short-term eyestrain, have little effect on visual performance, and have mixed results on sleep quality.

9. axonoptics.com axonoptics.com/blogs/post/do-blue-light-glasses-work-a-science-based-analysis?srsltid=AfmBOoppoD1e_qIUIzRdvVBqx7SitjNs4n9mCYX6yQBZ9419iLsegdss

Do Blue Light Glasses Work? Separating Fact From Fiction Proponents say that blue blockers can improve sleep quality, reduce eye strain from digital screens, and even cure headaches.

10. reddit.com reddit.com/r/HubermanLab/comments/12chplk/i_just_finished_testing_30_pairs_of_blueblocking/

I just finished testing 30 pairs of blue-blocking glasses! ... Seems like a pretty easy study to conduct but I don't think there are placebo controlled study showing better sleep when people wear blue ...