Tailored Light Treatment for Dementia

No longer recruiting at 1 trial location

Overseen By Mariana Figueiro, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Sleep medication, Melatonin

Disqualifiers: Brain vascular disease, Parkinson's, others

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how varying lengths of light exposure can improve sleep, mood, and reduce agitation in people with Alzheimer's disease. Participants will be randomly assigned to one of three groups to receive either 2 hours, 4 hours, or all-day morning light exposure as part of the Active Lighting Intervention (also known as Light Therapy or Bright Light Therapy). The trial will compare these groups to a control group receiving low light levels, referred to as the Control Lighting Intervention (also known as Light Therapy or Phototherapy). The study seeks individuals diagnosed with Alzheimer's or similar dementia who experience sleep difficulties. Participants should not have other significant eye or neurological conditions and should not use sleep medication or melatonin.

As an unphased trial, this study offers a unique opportunity to contribute to understanding how light exposure can enhance the quality of life for those with Alzheimer's.

Will I have to stop taking my current medications?

The trial requires that participants do not use sleep medication or oral melatonin, so you would need to stop these if you are currently taking them.

What prior data suggests that this light treatment is safe for individuals with Alzheimer's disease?

Research has shown that bright light therapy is generally safe for people with dementia. In one study, it improved sleep and reduced restlessness. Participants reported better sleep and mood. Another study found that bright light therapy enhanced thinking skills and reduced behavioral problems in older adults.

Overall, these studies indicate that bright light therapy is well-tolerated and positively affects mood and sleep. These studies reported no major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Active Lighting Intervention for dementia because it taps into an innovative approach by targeting the circadian system. Unlike traditional treatments that primarily focus on medications to address symptoms like memory loss or mood changes, this method uses specially designed lighting to influence the body's internal clock. This approach could potentially improve sleep patterns and overall well-being in dementia patients, offering a non-drug alternative that might work alongside or even enhance the effects of existing therapies.

What evidence suggests that this trial's lighting interventions could be effective for Alzheimer's disease?

Research has shown that light therapy can improve sleep and reduce agitation in people with dementia. In this trial, participants will receive either an Active Lighting Intervention or a Control Lighting Intervention. One study found that bright light therapy, similar to the Active Lighting Intervention, reduced nighttime awakenings. Another study demonstrated that it was more effective than regular lighting at enhancing mood and cognitive skills. Evidence also suggests that lighting aligned with the body's natural sleep-wake cycle can improve sleep and mood. Although results on reducing agitation are mixed, light therapy overall appears promising for people with dementia. ^{2 4 5 6 7}

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 individuals with Alzheimer's or related dementia, who have a Montreal Cognitive Assessment score below 25 and sleep disturbances indicated by a Pittsburgh Sleep Quality Index score of 5 or higher. It excludes those with major brain conditions, severe eye problems, use of sleep medication or melatonin, untreated sleep apnea, or severe restless leg syndrome.

Inclusion Criteria

I have Alzheimer's or similar dementia with a low cognitive score.

I have trouble sleeping, scoring 5 or more on a sleep quality test.

Exclusion Criteria

I have severe vision loss due to macular degeneration.

I use medication to help me sleep.

I have severe restless leg syndrome.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to one of three light exposure conditions: 2-h morning, 4-h morning, or all day light exposure

14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active Lighting Intervention
• Control Lighting Intervention

Trial Overview

The study tests how different durations of morning light exposure affect the sleep quality, mood, and agitation levels in people with Alzheimer's disease. Participants will be randomly placed into groups receiving either 2 hours of morning light, 4 hours of morning light, or all-day light exposure.

How Is the Trial Designed?

Group I: Active Lighting Intervention Active Control 2 Interventions

Lighting intervention designed to effect the circadian system then will receive the control lighting intervention.

Group II: Control Lighting Intervention Placebo Group 1 Intervention

Lighting intervention using low light levels designed to not effect the circadian system

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

In a study involving 10 elderly subjects with severe dementia, exposure to bright light (5000-8000 lux) for 45 minutes each morning over 4 weeks led to significant improvements in behavioral symptoms as measured by the Cohen-Mansfield Agitation Inventory and the BEHAVE-AD scale.

While the bright light treatment did not change sleep-wake measures, it did advance the timing of the subjects' activity rhythms, suggesting that bright light can positively influence behavior and activity patterns in severely demented individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in behavioral symptoms and advance of activity acrophase after short-term bright light treatment in severe dementia. Skjerve, A., Holsten, F., Aarsland, D., et al.[2022]

Ambient bright light therapy did not reduce agitation in institutionalized persons with dementia; in fact, it may have increased agitation levels compared to standard lighting, particularly in those with mild to moderate dementia.

The study involved 66 older participants and used a crossover design with different lighting conditions, revealing that responses varied by location, but overall, no lighting condition effectively alleviated agitation symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of ambient bright light on agitation in dementia. Barrick, AL., Sloane, PD., Williams, CS., et al.[2022]

Light therapy shows potential benefits in managing behavioral and psychological symptoms of dementia, particularly in improving sleep, mood, and agitation among older adults with cognitive impairment, based on a review of 36 studies.

However, the effects of light therapy on cognition, quality of life, and functional status appear to be limited, suggesting that while it can help with certain symptoms, it may not significantly enhance overall cognitive function or daily living activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of light therapy in older adults with cognitive impairment: A systematic review. Cibeira, N., Maseda, A., Lorenzo-López, L., et al.[2021]

Light therapy is used to help older individuals with dementia by resetting their biological clock, enhancing cognitive function, and reducing behavioral symptoms, but the studies on this treatment often lack detailed descriptions of the lighting used.

A review of 12 studies revealed that the methodological quality is generally poor, with insufficient and incorrect metrics for describing lighting, suggesting that involving a light engineer could improve the robustness of future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shedding a Light on Phototherapy Studies with People having Dementia: A Critical Review of the Methodology from a Light Perspective. Aarts, MP., Aries, MB., Diakoumis, A., et al.[2018]

The study involved 60 patients with mild to moderate dementia, who received low power transcranial near-infrared (tNIR) light treatment for 8 weeks, showing significant cognitive improvements without reported adverse effects.

Patients treated with tNIR light experienced an average increase of 4.8 points on the MMSE and reported better sleep, reduced anxiety, and improved mood, indicating the treatment's potential benefits for both patients and caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Near Infrared Light Stimulations Improve Cognition in Patients with Dementia. Nizamutdinov, D., Qi, X., Berman, MH., et al.[2021]

Light therapy shows some potential in improving sleep disturbances and circadian activity in patients with behavioral and psychological symptoms of dementia, particularly in those with vascular dementia compared to Alzheimer's disease.

However, the overall efficacy, clinical practicability, and safety of light therapy for these symptoms remain inconclusive due to a lack of well-designed studies, highlighting the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light therapy for behavioural and psychological symptoms of dementia. Skjerve, A., Bjorvatn, B., Holsten, F.[2015]

A systematic review of 13 randomized controlled trials found no significant effects of light therapy on circadian activity rhythm parameters or sleep quality in individuals with dementia, indicating that this nonpharmacological treatment may not be effective.

The overall risk of bias in the included studies was high, suggesting that more rigorous and high-quality research is needed before light therapy can be recommended for improving sleep and circadian rhythms in dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light Intervention Effects on Circadian Activity Rhythm Parameters and Nighttime Sleep in Dementia Assessed by Wrist Actigraphy: A Systematic Review and Meta-Analysis. Canazei, M., Papousek, I., Weiss, EM.[2022]

Light therapy significantly reduced the number of awakenings during sleep in people with dementia, based on a meta-analysis of 11 randomized controlled studies involving 4315 articles screened.

However, light therapy did not show significant effects on reducing agitation or depression, indicating its primary benefit may be in improving sleep disturbances rather than overall mood or behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Light Therapy on Sleep, Agitation and Depression in People With Dementia: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Fong, KN., Ge, X., Ting, KH., et al.[2023]

The DEM.LIGHT trial, involving 61 patients with severe dementia over 24 weeks, found that bright light treatment advanced the acrophase (the peak of activity) in the intervention group compared to the control group, suggesting some influence on circadian rhythms.

However, overall, the bright light intervention did not significantly improve other rest-activity measures for dementia patients, indicating limited efficacy in enhancing their daily rhythms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Bright Light Treatment on Rest-Activity Rhythms in People with Dementia: A 24-Week Cluster Randomized Controlled Trial. Kolberg, E., Pallesen, S., Hjetland, GJ., et al.[2021]

Citations

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The results show that light therapy significantly improved sleep disturbance in terms of reducing the number of awakenings, but did not significantly improve ...

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frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2021.782160/full

Pilot Study of the Effects of Bright Ambient Therapy on ...

In this pilot study, bright light therapy was more effective than general lighting at improving BPSD and cognitive function among older adults ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S1041610224025511

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Results: There was limited evidence of reduction in agitation in people on active treatment, sleep was improved and a suggestion of greater efficacy in the ...

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This study demonstrates that a circadian-effective lighting intervention delivering bright days and dark nights improves measures of sleep and mood in dementia ...

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Light therapy and dementia

One small but well-conducted study showed promising effects of bright light therapy on restlessness and disturbed sleep for people with dementia. A large and ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8394855/

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Bright light therapy (BLT) has demonstrated positive short- and long-term effects in people with cognitive impairment or dementia; however, ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8219492/

Transcranial Near Infrared Light Stimulations Improve ...

Many patients reported improved sleep after ~7 days of treatment. Caregivers noted that patients had less anxiety, improved mood, energy, and positive daily ...