Tailored Lighting for Parkinson’s Disease

Overseen By Maya Rawal

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special lighting treatment, known as Tailored Lighting Intervention (TLI), might improve sleep and reduce fatigue in people with Parkinson's disease. Participants will first wear a device to track their sleep for a week. Those with sleep issues will then use the lighting treatment for eight weeks to assess its impact on sleep and daily tiredness. This trial suits individuals diagnosed with Parkinson's disease who struggle with sleep or cognitive clarity. As an unphased trial, it provides a unique opportunity to explore innovative solutions for enhancing sleep and daily functioning.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, but you should confirm with the trial organizers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this tailored lighting intervention is safe for Parkinson's patients?

Research has shown that light therapy is generally safe for people with Parkinson's disease. Studies have found it can help with both movement problems and sleep issues. For example, one study found that light therapy improved sleep in Parkinson's patients without causing major side effects. Another study demonstrated that light therapy could help with symptoms and was well-tolerated by patients. Overall, the safety information is promising, with few reports of negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for Parkinson’s disease, which often focus on medication or surgery to manage symptoms, the Tailored Lighting Intervention (TLI) uses specialized lighting to potentially improve patient well-being. This non-invasive approach involves exposure to tailored lighting for two hours each day, aiming to regulate sleep and mood, which are often disrupted in Parkinson's. Researchers are excited because this method could offer a unique, drug-free way to enhance quality of life for patients without the side effects associated with standard treatments.

What evidence suggests that this tailored lighting intervention is effective for sleep disturbances in Parkinson's disease?

Research has shown that special lighting treatments can help people with Parkinson's disease. One study found that light therapy improved movement in patients. Another study showed that bright light therapy reduced sleep problems compared to a placebo treatment. Early evidence also suggests that personalized daylight therapy might improve sleep in Parkinson's patients. This trial will specifically evaluate the Tailored Lighting Intervention (TLI), which uses a personalized lighting approach. These findings support the potential benefits of special lighting treatments for sleep and other symptoms in Parkinson's disease. ^{1 4 5 6 7}

Who Is on the Research Team?

Rachel Saunders-Pullman, MD

Principal Investigator

Mount Sinai Beth Israel

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's disease who are experiencing sleep problems or cognitive difficulties. There are no specific exclusion criteria, so anyone with these conditions can potentially participate.

Inclusion Criteria

I have Parkinson's disease and struggle with sleep or thinking clearly.

Exclusion Criteria

There are no exclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Data Collection

Participants undergo one week of baseline data collection using the actigraph and light meter, and one night of overnight urine collection

1 week

1 visit (in-person)

Treatment

Participants receive a tailored lighting intervention for 2 hours each morning for 8 weeks

8 weeks

Home-based intervention

Follow-up

Participants are monitored for changes in sleep, fatigue, and circadian entrainment via actigraphy and urinary melatonin levels

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Tailored Lighting Intervention (TLI)

Trial Overview The study is testing a Tailored Lighting Intervention (TLI) to see if it improves sleep and fatigue in people with Parkinson's. Participants will also wear an Actigraph device for seven days to monitor their sleep patterns.

How Is the Trial Designed?

Group I: Tailored Lighting Intervention (TLI) Experimental Treatment 2 Interventions

The TLI will be performed for 2 hours each day over an 8-week period During the last week of the lighting, participants will be asked to wear the actigraph and light meter again for 7 days

Tailored Lighting Intervention (TLI) is already approved in United States, European Union for the following indications:

Approved in United States as Light Therapy for:

• Sleep disturbances in Parkinson's disease
• Excessive daytime sleepiness

Approved in European Union as Light Therapy for:

• Sleep disturbances in Parkinson's disease
• Circadian rhythm disorders

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

Light therapy shows promise in improving both motor and non-motor symptoms in patients with Parkinson's disease, indicating its potential as a novel treatment option.

Further research is needed to develop mechanism-based protocols for light therapy, which could enhance its effectiveness and safety in treating Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light Therapy in Parkinson's Disease: Towards Mechanism-Based Protocols. Fifel, K., Videnovic, A.[2019]

Light therapy (LT) significantly improves motor function in patients with Parkinson's disease, with a mean difference of -4.68 in motor scores compared to controls, indicating its potential as an effective non-pharmacological treatment.

LT also positively impacts non-motor symptoms, showing significant reductions in depression and improvements in sleep disturbances, suggesting a broad therapeutic benefit for individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Light Therapy as a Home Treatment for Motor and Non-Motor Symptoms of Parkinson Disease: A Meta-Analysis. Sun, W., Yan, J., Wu, J., et al.[2022]

In a controlled trial involving patients with Parkinson's disease who had previously used bright light therapy (BT) for 4 months to 5 years, those who continued with polychromatic light therapy showed significant improvements in motor and secondary symptoms, as measured by various scales including the MDSUPDRS and PDQ-39.

Patients who switched to red light or discontinued BT experienced deterioration in their symptoms, highlighting the efficacy of polychromatic light therapy in managing both primary and secondary symptoms of Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polychromatic Light Exposure as a Therapeutic in the Treatment and Management of Parkinson's Disease: A Controlled Exploratory Trial. Willis, GL., Boda, J., Freelance, CB.[2020]

A retrospective study involving 129 Parkinson's disease patients indicated that light therapy, when combined with controlled dopamine replacement therapy, can lead to significant improvements in motor and non-motor symptoms, especially in patients who adhered to the treatment regimen.

Patients who consistently followed the light therapy showed better outcomes and a reduced need for medication, resulting in fewer side effects compared to those who were less compliant or discontinued treatment, suggesting that light therapy may help slow the progression of Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A historical justification for and retrospective analysis of the systematic application of light therapy in Parkinson's disease. Willis, GL., Moore, C., Armstrong, SM.[2022]

Bright light therapy (BLT) did not significantly reduce depressive symptoms compared to a control light in patients with Parkinson disease and major depressive disorder, based on a study involving 83 participants over 3 months.

However, BLT was more effective in improving subjective sleep quality and reducing salivary cortisol levels, suggesting it may help with sleep issues related to depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light therapy for depression in Parkinson disease: A randomized controlled trial. Rutten, S., Vriend, C., Smit, JH., et al.[2019]

Bright light therapy (BLT) significantly improves depressive symptoms in patients with Parkinson's disease, as shown by a meta-analysis of five randomized controlled trials involving 173 patients, with a moderate effect size (SMD = 0.34).

BLT also effectively alleviates insomnia symptoms in Parkinson's patients, demonstrating a strong effect size (SMD = 1.15), while no improvements were noted in the control light group, highlighting BLT's specific benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of bright light therapy on depression and sleep disturbances in patients with Parkinson's disease: a systematic review and meta-analysis of randomized controlled trials. Lin, F., Su, Y., Weng, Y., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-dyssomnias-10-2022-f3621

Tailored Lighting for Parkinson's Disease Light therapy (LT) significantly improves motor function in patients with Parkinson's disease, with a mean difference of -4.68 in motor scores compared to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12281491/

Supplemental Ambient Lighting Intervention to Improve ... Their pilot study showed that a 14-day course of bright light therapy (compared to a dim red light placebo intervention) significantly reduced ...

3. neurology.org neurology.org/doi/10.1212/WNL.0000000000202783

Pilot Tailored Lighting Intervention on Sleep Disturbances ... This pilot study demonstrates the feasibility of conducting an at home, short-term tailored lighting intervention therapy for participants with PD.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2211124725006369

Bright-light treatment ameliorates motor and non ... In this study, we demonstrate that bright-light treatment ameliorates both motor and non-motor symptoms of PD in mice through distinct visual pathways.

5. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00053-1/fulltext

Efficacy of biologically-directed daylight therapy on sleep ... This RCT provides early evidence that a personalised, biologically-directed daylight therapy may improve sleep in patients with PD, and further ...

6. withpower.com withpower.com/trial/lighting-intervention-for-parkinsons-disease-6e320

Lighting Intervention for Parkinson's Disease Research suggests that light therapy is generally safe for humans, with studies showing it can improve symptoms in Parkinson's disease patients with fewer side ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9276174/

Efficacy and safety of light therapy for Parkinson disease - PMC Previous studies have found that LT might have a substantial therapeutic potential for motor and non-motor symptoms of PD. LT is usually administered with ...