Lighting Intervention 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)

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special lighting treatment called Tailored Lighting Intervention (LIT) to determine if it improves sleep in people with Parkinson's disease. Participants will wear a device to track their sleep for a week. Those with sleep problems will then use the lighting treatment to assess its effects on sleep quality, tiredness, and body clock regulation. Individuals with Parkinson's who experience sleep or memory issues might be suitable for this trial. As an unphased trial, it provides a unique opportunity to explore innovative solutions for better sleep.

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.

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 lighting intervention is safe for individuals with Parkinson's disease?

Research has shown that light therapy is generally safe for people with Parkinson's disease. Studies have found that it can improve symptoms with minimal side effects. Early evidence suggests that personalized light therapy might enhance sleep for Parkinson’s patients. Overall, light therapy, including customized lighting treatment, has been well-tolerated in other studies. This indicates it is likely safe for use, although individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for Parkinson's disease, which often involve medications like levodopa or dopamine agonists to manage symptoms, the Tailored Lighting Intervention (TLI) focuses on using light exposure to potentially improve patient outcomes. Researchers are excited about this approach because it leverages light as a non-invasive, side-effect-free option that might enhance sleep quality and overall well-being. The intervention is unique because it uses personalized lighting schedules designed to optimize circadian rhythms, which could be a game-changer for managing symptoms such as sleep disturbances and mood fluctuations commonly associated with Parkinson's.

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

Research shows that special lighting can help people with Parkinson's disease sleep better. This trial will study the Tailored Lighting Intervention (TLI), which participants will receive for 2 hours each day over a 4-week period. Studies have found that light therapy can improve sleep, movement, and mood in these patients. Specifically, one study discovered that personalized daylight improved sleep quality. Another study showed that bright-light treatments helped with both movement and other symptoms in animal models of Parkinson's. This therapy is easy to use and may help with sleep and tiredness. ^{1 3 6 7 8}

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 people with Parkinson's disease who have trouble sleeping or thinking clearly. They'll need to wear a sleep tracker for a week. Those with sleep issues may get special lighting in their homes to see if it helps them sleep better and feel less tired.

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 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 4 weeks

4 weeks

1 visit (in-person) at start, 1 visit (in-person) at end

Follow-up

Participants are monitored for changes in sleep duration and efficiency, and melatonin levels are assessed

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Tailored Lighting Intervention (LIT)

Trial Overview The study tests whether a Tailored Lighting Intervention (TLI) can improve sleep, reduce fatigue, and adjust the body's internal clock in Parkinson's patients by measuring changes in melatonin levels found in urine.

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 a 4-week period. During the last week of the lighting, participants will be asked to wear the actigraph and light meter again for 7 days

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 (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]

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]

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]

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]

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]

Citations

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

Tailored Lighting for Parkinson's Disease · Info for Participants Meta-analyses and controlled trials suggest that light therapy is effective in improving motor function, depression, and sleep disturbances in Parkinson's ...

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

Supplemental Ambient Lighting Intervention to Improve ... Passive and easily administered lighting interventions for improving sleep in PD patients hold promise as a treatment for mitigating symptoms ...

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. 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 ...

5. 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.

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40903343/

A double-blind, controlled trial of circadian effective light ... Previous studies suggest that light therapy (LT) provides benefits for motor and non-motor features of PD. This study evaluated Circadian ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3540893/

Bright Light Therapy in Parkinson's Disease: An Overview ... Bright light therapy (BLT) restores circadian rhythmicity effectively in mood- and sleep-disturbed patients without PD.