Novel Lighting for Fall Prevention in Dementia

Overseen By Johanna S Hickey, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Blindness, Hospice, Worsening state, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if special low-intensity lights can prevent falls at night for people with dementia in assisted living facilities. The lights outline doorframes, providing visual cues that may aid balance and stability. Participants will experience various lighting setups, including a novel lighting condition, in their rooms over a year to compare effects. This trial suits residents with dementia who live in assisted living, are not blind, and do not have an overnight sitter every night. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance safety and quality of life for those with dementia.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What prior data suggests that this novel lighting intervention is safe for assisted living residents with dementia?

Research shows that the new lighting system under testing is generally safe and can help reduce falls at night. Early studies found that people using this lighting system did not experience any harm or negative effects. Designed to be subtle, the system provides visual cues to aid balance, especially at night. Similar light therapies have been used safely in dementia care, making this a promising option for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel lighting condition to help prevent falls in patients with dementia. Unlike standard fall prevention methods, which often rely on physical aids or medication, this approach focuses on environmental modifications through tailored lighting sequences. By adjusting lighting conditions throughout the year, the trial aims to enhance visibility and reduce fall risk without the need for more intrusive interventions. The hope is that this innovative, non-invasive strategy could offer a safer, more comfortable living environment for individuals with dementia, potentially transforming how we approach fall prevention in this vulnerable group.

What evidence suggests that this novel lighting intervention is effective for preventing falls in dementia patients?

Research has shown that a new lighting system, which participants in this trial may experience as part of the novel lighting condition, can help reduce nighttime falls for people with dementia. An earlier study found a 34% reduction in falls with these special lights compared to regular lights. These lights provide clear visual signals that enhance balance and safety. Cameras tracked falls, confirming the effectiveness of this lighting. These promising results suggest that the new lighting can make nighttime safer for residents in assisted living facilities. ^{1 2 3 6 7}

Who Is on the Research Team?

Sheryl Zimmerman, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for assisted living residents with dementia who try to get out of bed, are not wheelchair-bound, blind, on hospice care, or expected to die/transfer within the study year. They must live alone in a room but can share a bathroom.

Inclusion Criteria

I have been diagnosed with dementia.

Lives in a participating AL community

Not blind

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the novel lighting condition or control lighting condition in a crossover design to test the effectiveness in reducing nighttime falls

12 months

Quarterly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control Lighting Condition
• Novel Lighting Condition

Trial Overview

The study tests if special lights around doorframes can reduce nighttime falls in people with dementia. It's a one-year crossover trial where participants experience both the new lighting and regular conditions at different times.

How Is the Trial Designed?

Group I: Lighting Sequence 4: LLCC Experimental Treatment 2 Interventions

In this arm, the participant will receive the novel lighting condition (L) for the first two quarters (180 days) and then crossover to the control lighting condition (C) for the last two quarters (180 days). Q1 - Novel lighting Q2 - Novel lighting Q3 - Control lighting Q4 - Control lighting

Group II: Lighting Sequence 3: LCCL Experimental Treatment 2 Interventions

In this arm, the participant will receive the novel lighting condition (L) for the first quarter (90 days) and then crossover to the control lighting condition (C) for the next two quarters (180 days) and finally crossover again to the novel condition (L) for the last quarter (90 days). Q1 - Novel lighting Q2 - Control lighting Q3 - Control lighting Q4 - Novel lighting

Group III: Lighting Sequence 2: CLLC Experimental Treatment 2 Interventions

In this arm, the participant will receive the control lighting condition (C) for the first quarter (90 days) and then crossover to the novel lighting condition (L) for the next two quarters (180 days) and finally crossover again to the control condition (C) for the last quarter (90 days). Q1 - Control lighting Q2 - Novel lighting Q3 - Novel lighting Q4 - Control lighting

Group IV: Lighting Sequence 1: CCLL Experimental Treatment 2 Interventions

In this arm, the participant will receive the control lighting condition (C) for the first two quarters (180 days) and then crossover to the novel lighting condition (L) for the last two quarters (180 days). Q1 - Control lighting Q2 - Control lighting Q3 - Novel lighting Q4 - Novel lighting

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

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]

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]

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]

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]

Increasing daytime environmental illumination for 4 weeks improved the stability of rest-activity rhythms in 22 dementia patients with intact vision, suggesting that light can positively influence circadian rhythms in this population.

However, the same increase in light did not benefit visually impaired patients, indicating that the effectiveness of light therapy may depend on visual capability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indirect bright light improves circadian rest-activity rhythm disturbances in demented patients. Van Someren, EJ., Kessler, A., Mirmiran, M., et al.[2022]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11486553/

Feasibility of A Novel Lighting System to Reduce Nighttime ...

The primary intervention effectiveness outcome was the number of nighttime falls; the exposure variable was the number of nights observed (not ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1525861024006492

Feasibility of a Novel Lighting System to Reduce Nighttime ...

Cameras captured falls data for 92% of 8591 resident nights. The incidence density for falls was 34% lower in the intervention condition than the control ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05973448

NCT05973448 | The Nightlight Falls Prevention Study

The study investigators recently completed a NIH R21 exploratory/developmental randomized crossover trial of this system and found a 34% decrease in falls due ...

4.

jamda.com

jamda.com/article/S1525-8610(24)00649-2/abstract

Feasibility of a Novel Lighting System to Reduce Nighttime ...

The incidence density for falls was 34% lower in the intervention condition than the control condition (incidence density ratio 0.66, 95% CI ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39182511/

Feasibility of a Novel Lighting System to Reduce Nighttime ...

Cameras captured falls data for 92% of 8591 resident nights. The incidence density for falls was 34% lower in the intervention condition than the control ...

6.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/07334648241302552

The Effect of Lighting Levels on Fall Risk in Long-Term ...

Feasibility of a novel lighting system to reduce nighttime falls in assisted living residents with dementia. Journal of the American Medical ...

7.

withpower.com

withpower.com/trial/phase-alzheimer-disease-7-2023-eb3f7

Novel Lighting for Fall Prevention in Dementia

The research on light therapy for dementia suggests it is generally safe, as it is used to help with sleep and behavior without reports of harm. However, the ...