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

390 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Novel Lighting Condition for fall prevention in dementia?

Research shows that bright light therapy can improve behavioral symptoms and stabilize daily activity patterns in people with dementia, which might help reduce falls by promoting better daily routines and reducing agitation. ^{1 2 3 4 5}

Is novel lighting for fall prevention in dementia safe for humans?

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 quality of studies varies, and more detailed research is needed to confirm safety. ^{3 6 7 8 9}

How does the Novel Lighting Condition treatment differ from other treatments for fall prevention in dementia?

The Novel Lighting Condition treatment is unique because it uses specific lighting to potentially improve sleep patterns and reduce agitation in people with dementia, which may help prevent falls. Unlike traditional treatments that might focus on medication or physical therapy, this approach leverages environmental light to influence behavior and activity rhythms. ^{1 2 4 5 10}

What is the purpose of this trial?

This project will test the effectiveness of a novel intervention consisting of unobtrusive, low-intensity, horizontal and vertical lights that outline the bathroom or entry way doorframe in residents' rooms and provide visual cues to promote postural stability. Specifically, this pragmatic crossover trial will enroll 390 assisted living residents with dementia and follow them for one year, comparing the incidence of nighttime falls during the lighting condition to the incidence of falls during the control condition; secondarily, it will determine whether and to what extent the intervention effect is modified by resident- and environmental-level risk factors, and satisfaction with the lighting system.

Research Team

Sheryl Zimmerman, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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

Lives in a participating AL community

I have been diagnosed with dementia.

I try to get out of bed.

Exclusion Criteria

Not applicable.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

References

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

High-intensity environmental light in dementia: effect on sleep and activity. [2015]

2. 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]

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

Indirect bright light improves circadian rest-activity rhythm disturbances in demented patients. [2022]

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

The effect of ambient bright light therapy on depressive symptoms in persons with dementia. [2022]

5. England pubmed.ncbi.nlm.nih.gov

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

6. 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]

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

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

8. 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]

9. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Implementation of Dynamic Lighting in a Nursing Home: Impact on Agitation but not on Rest-Activity Patterns. [2018]

10. 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]