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

57 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.

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 Lighting Intervention for Parkinson’s Disease is an effective treatment?

The available research shows that Lighting Intervention, 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 therapy 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 lighting treatment for Parkinson's Disease?

Research shows that light therapy can significantly improve both movement and non-movement symptoms in people with Parkinson's Disease. Studies found that patients using light therapy had better motor function and experienced less depression and sleep problems compared to those who did not use the therapy. ^{1 2 3 4 5}

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

The safety of light therapy for Parkinson's disease has been evaluated in several studies. A meta-analysis found that light therapy significantly improved motor and non-motor symptoms, including depression and sleep disturbances, without reporting significant safety concerns. Another study highlighted the potential of light therapy to improve symptoms with fewer side effects compared to traditional dopamine replacement therapy. Overall, the existing research suggests that light therapy is a safe treatment option for Parkinson's disease, but further controlled investigations are recommended to confirm these findings. ^{1 2 3 5 6}

Is light therapy safe for humans?

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 effects compared to some traditional treatments. ^{1 2 3 5 6}

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

Yes, Tailored Lighting Intervention (LIT) 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. It has been found to be effective and safe, offering a non-drug option to help manage the disease. ^{1 2 3 4 5}

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

The Tailored Lighting Intervention (LIT) is unique because it uses light therapy to target the circadian system, which may help improve both motor and non-motor symptoms of Parkinson's disease, unlike traditional treatments that primarily focus on replacing dopamine. This approach is non-invasive and can potentially reduce symptoms like depression and sleep disturbances, offering a novel way to manage the condition. ^{1 2 3 4 5}

Research Team

Rachel Saunders-Pullman, MD

Principal Investigator

Mount Sinai Beth Israel

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

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

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

3. England pubmed.ncbi.nlm.nih.gov

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

4. 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]

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]