Tailored Light Treatment for Dementia

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

135 Participants Needed

Trial Summary

What is the purpose of this trial?

Aim 2 will investigate the effect of 3 different light exposure lengths on sleep, mood and agitation in persons with Alzheimer's disease. Participants will be randomly assigned to one of three conditions of light exposure: 1) 2-h morning light exposure; 2) 4-h morning light exposure; and 3) all day light exposure.

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 data supports the effectiveness of the treatment Tailored Light Treatment for Dementia?

Research shows that bright light therapy can improve behavioral symptoms and activity rhythms in people with severe dementia. Additionally, transcranial near-infrared light treatments have been found to enhance cognitive functions and improve mood and sleep in dementia patients. ^{1 2 3 4 5}

Is light therapy safe for people with dementia?

Research shows that light therapy, including transcranial near-infrared light, is generally safe for people with dementia, with no reported health or adverse side effects during or after treatment in a study of 57 participants. ^{1 2 5 6 7}

How is the Active Lighting Intervention treatment different from other treatments for dementia?

Active Lighting Intervention, or light therapy, is unique because it uses bright light exposure to help reset the biological clock and improve behavioral symptoms in people with dementia, unlike traditional treatments that often rely on medication. This non-drug approach focuses on influencing circadian rhythms, which are often disrupted in dementia patients, by providing timed light exposure to improve activity rhythms and reduce agitation. ^{1 2 4 8 9}

Research Team

Mariana Figueiro, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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 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]

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]

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]

References

1. United States 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. [2023]

2. United States 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. [2018]

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

Impact of ambient bright light on agitation in dementia. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Improvement in behavioral symptoms and advance of activity acrophase after short-term bright light treatment in severe dementia. [2022]

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

Transcranial Near Infrared Light Stimulations Improve Cognition in Patients with Dementia. [2021]

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

Application of light therapy in older adults with cognitive impairment: A systematic review. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Light therapy for behavioural and psychological symptoms of dementia. [2015]

8. Switzerland 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. [2021]

9. United States 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. [2022]