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

48 Participants Needed

Trial Summary

What is the purpose of this trial?

50 participants with Parkinson's disease will be recruited to complete actigraphy studies to assess sleep disturbances. For this, participants will wear an Actigraph for seven days. Thirty of these participants with sleep disturbance will go on to receive a tailored lighting intervention (TLI) to assess the effect on sleep, fatigue, and circadian entrainment via urinary melatonin levels.

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 data supports the idea that Tailored Lighting for Parkinson’s Disease is an effective treatment?

The available research shows that Tailored Lighting, or Light Therapy, is effective in improving both motor and non-motor symptoms in Parkinson's Disease patients. One study found that patients receiving light therapy had better motor function and experienced less depression and sleep disturbances compared to those exposed to dim-red light. Another study showed that patients continuing with polychromatic light therapy improved in motor and secondary symptoms, while those who stopped or used red light did not. These findings suggest that light therapy can be a beneficial treatment for managing Parkinson's Disease symptoms. ^{1 2 3 4 5}

What data supports the effectiveness of the Tailored Lighting Intervention (TLI) treatment for Parkinson's Disease?

Research shows that light therapy can significantly improve both motor and non-motor symptoms in Parkinson's patients, such as better movement and reduced depression and sleep issues. Studies also indicate that bright light therapy can help with depression in Parkinson's, and polychromatic light exposure has shown benefits in reducing primary and secondary symptoms. ^{1 2 3 4 5}

What safety data exists for light therapy in Parkinson's disease treatment?

The research indicates that light therapy, including bright light therapy and polychromatic light exposure, has been studied for its efficacy and safety in treating motor and non-motor symptoms of Parkinson's disease. Meta-analyses and controlled trials suggest that light therapy is effective in improving motor function, depression, and sleep disturbances in Parkinson's patients. While the exact mechanisms are still being explored, the studies generally support the safety and potential benefits of light therapy in managing Parkinson's disease symptoms. ^{1 2 3 4 6}

Is light therapy safe for humans?

Research on light therapy for Parkinson's disease suggests it is generally safe for humans, with studies showing improvements in motor and non-motor symptoms without significant safety concerns. ^{1 2 3 4 6}

Is the treatment Tailored Lighting Intervention (TLI) a promising treatment for Parkinson's Disease?

Yes, Tailored Lighting Intervention (TLI) is a promising treatment for Parkinson's Disease. Research shows that light therapy can improve both movement and non-movement symptoms, like depression and sleep problems, in people with Parkinson's Disease. Studies have found that patients using light therapy had better motor function and felt less depressed and more rested. ^{1 2 3 4 6}

How is the Tailored Lighting Intervention treatment different from other treatments for Parkinson's disease?

The Tailored Lighting Intervention (TLI) is unique because it uses strategically applied polychromatic light to improve both motor and non-motor symptoms of Parkinson's disease by potentially influencing the circadian system, unlike traditional treatments that primarily focus on replacing dopamine to address motor symptoms. ^{1 2 3 4 6}

Research Team

Rachel Saunders-Pullman, MD

Principal Investigator

Mount Sinai Beth Israel

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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) 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]

References

1. United States 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Light Therapy in Parkinson's Disease: Towards Mechanism-Based Protocols. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Polychromatic Light Exposure as a Therapeutic in the Treatment and Management of Parkinson's Disease: A Controlled Exploratory Trial. [2020]

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

Bright light therapy for depression in Parkinson disease: A randomized controlled trial. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

A historical justification for and retrospective analysis of the systematic application of light therapy in Parkinson's disease. [2022]

6. Netherlands 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. [2021]