Light Therapy for Alzheimer's Disease

Recruiting at 1 trial location

Overseen By Mariana Figueiro, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Sleep medication

Disqualifiers: Severe sleep apnea, Epilepsy, others

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of light therapy, including Rhythmic Light Therapy, might assist people with mild cognitive impairment or mild Alzheimer's disease. Participants will experience one of four lighting conditions: some with rhythmic light that flickers and others with non-rhythmic light, to determine if it can improve sleep and cognitive function. The setup is simple, with a light placed on a table and turned on for two hours each morning. Individuals with sleep disturbances who live at home or in assisted or independent living may be suitable candidates.

As an unphased trial, this study provides a unique opportunity to investigate innovative light therapies that could enhance daily life.

Do I have to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking sleep medication, you cannot participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that light therapy is usually well-tolerated by people with Alzheimer's disease. Studies have found that bright light therapy can improve sleep patterns and daily routines in people with dementia. Few reports of serious side effects make it a relatively safe option for those considering joining a trial. Additionally, using a rhythmic light flicker at 40 hertz is believed to gently boost brain activity without causing harm. While side effects are rare, participants should always inform the study team of any discomfort. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using rhythmic light therapy for Alzheimer's disease because it offers a non-invasive approach that could potentially influence the brain's natural rhythms and improve cognitive function. Unlike traditional treatments, which often rely on medications to manage symptoms, this therapy uses a specific pattern of light exposure to potentially enhance brain activity. The idea is that by syncing with the brain's own rhythms, rhythmic light therapy might boost memory and attention without the side effects commonly associated with drugs. This novel method could open up new possibilities for managing Alzheimer's symptoms in a way that’s gentle yet effective.

What evidence suggests that this trial's light therapy treatments could be effective for Alzheimer's disease?

Research has shown that light therapy can aid people with Alzheimer's disease by enhancing sleep and behavior. One study found that it improved nighttime sleep and daytime alertness. Another review demonstrated improvements in sleep, cognition, and mood for those with Alzheimer's. These benefits likely stem from light's ability to regulate the body's internal clock, aligning sleep patterns. This trial will compare various combinations of active and placebo light and rhythm therapies to assess their effectiveness. Overall, evidence suggests that light therapy could be a promising method for managing Alzheimer's symptoms. ^{1 2 4 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 people living at home or in assisted living with mild Alzheimer's or cognitive impairment, who have sleep issues but aren't on sleep meds. They can't join if they have severe eye problems, live in nursing care, or have certain neurological conditions.

Inclusion Criteria

I have mild cognitive issues or mild Alzheimer's, confirmed by a specific test score.

I live at home or in a facility that helps with daily activities.

I have trouble sleeping, as shown by my sleep test score.

Exclusion Criteria

I have severe sleep apnea or restless leg syndrome.

I do not have severe eye conditions like obstructing cataracts, macular degeneration, or blindness.

I am currently taking medication to help me sleep.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants undergo a baseline week before starting the assigned lighting condition

1 week

Treatment

Participants experience their assigned lighting condition for two hours in the morning for 8 weeks

8 weeks

8 assessments (in-person)

Washout

A 4-week washout period where no treatment is administered

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rhythmic Light Therapy

Trial Overview The study tests how different lights affect Alzheimer's patients' brains and sleep. Participants will try a placebo light or a circadian-effective light, both with either rhythmic or random flicker, for two hours each morning over eight weeks.

How Is the Trial Designed?

Group I: Placebo Light plus Active Rhythm Active Control 2 Interventions

The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.

Group II: Active Intervention plus Active Rhythm Active Control 2 Interventions

The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.

Group III: Active Light plus Placebo Rhythm Active Control 2 Interventions

The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.

Group IV: Placebo Light plus Placebo Rhythm Placebo Group 2 Interventions

The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.

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

Timed bright light exposure may offer a low-risk alternative to medication for addressing sleep and circadian rhythm issues in Alzheimer's Disease, but the evidence from 27 studies remains inconclusive.

The studies varied widely in their methods and designs, highlighting the need for more standardized research to better understand the effects of light interventions on sleep and circadian rhythms in AD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Actigraphy for Assessing Light Effects on Sleep and Circadian Activity Rhythm in Alzheimer's Dementia: A Narrative Review. Canazei, M., Turiaux, J., Huber, SE., et al.[2020]

A pilot study involving community-dwelling individuals with Alzheimer's disease tested the effects of phototherapy using light visors over a 10-day period, but did not find consistent improvements in sleep patterns or nighttime awakenings.

While one subject experienced increased total sleep time, the overall results suggest that factors like insufficient light exposure duration and the advanced stage of Alzheimer's may limit the effectiveness of light therapy in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phototherapy for patients with Alzheimer disease with disturbed sleep patterns: results of a community-based pilot study. Colenda, CC., Cohen, W., McCall, WV., et al.[2019]

A tailored lighting intervention using low-level bluish-white light significantly improved sleep quality and efficiency in nursing home residents with Alzheimer's disease and related dementias over a 4-week period.

The intervention also led to reductions in depression and agitation scores, indicating potential behavioral benefits alongside improved sleep, suggesting that light therapy could be a valuable nonpharmacological treatment for ADRD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailored lighting intervention improves measures of sleep, depression, and agitation in persons with Alzheimer's disease and related dementia living in long-term care facilities. Figueiro, MG., Plitnick, BA., Lok, A., et al.[2022]

The 11-week study involving 35 individuals with Alzheimer's disease and related dementia showed that a tailored lighting intervention significantly improved circadian entrainment and sleep efficiency, while also reducing depression symptoms in participants.

Caregivers also benefited from the lighting intervention, experiencing improved circadian rhythms, sleep efficiency, and longer sleep duration, suggesting that this approach could be beneficial for other populations with sleep issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailored Lighting Intervention for Persons with Dementia and Caregivers Living at Home. Figueiro, MG., Hunter, CM., Higgins, P., et al.[2022]

A self-luminous light table effectively increased sleep duration and efficiency in individuals with Alzheimer's disease over a four-week intervention, compared to a baseline week.

The use of this light table also significantly reduced agitation and depression scores, highlighting its potential as a practical treatment method for improving sleep and mood in dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research Note: A self-luminous light table for persons with Alzheimer's disease. Figueiro, MG., Plitnick, B., Rea, MS.[2020]

In a study of 46 institutionalized patients with severe Alzheimer's disease, morning bright light therapy significantly improved rest-activity rhythm in those with the most severe disruptions, indicating its potential as a targeted intervention.

However, the overall effectiveness of bright light therapy on sleep quality and rest-activity measures was limited, suggesting that it may not benefit all patients equally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of morning bright light treatment for rest-activity disruption in institutionalized patients with severe Alzheimer's disease. Dowling, GA., Hubbard, EM., Mastick, J., et al.[2019]

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 is an effective, evidence-based treatment for Seasonal Affective Disorder, influencing circadian rhythms that affect sleep, mood, and cognition, based on 40 years of clinical trials.

For optimal results, light therapy should use devices that provide 10,000 lux of white light for 30-60 minutes in the early morning, with ongoing monitoring to adjust treatment as needed and manage any side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CME: Light Therapy: Why, What, for Whom, How, and When (And a Postscript about Darkness). Wirz-Justice, A., Terman, AM.[2022]

A 14-week clinical trial with 46 patients showed that a tailored lighting intervention significantly improved sleep quality, as measured by the Pittsburgh Sleep Quality Index, compared to both baseline and control conditions.

The lighting intervention also led to notable improvements in mood and behavior, evidenced by reduced depression and agitation scores, indicating its potential as an effective nonpharmacological treatment for individuals with Alzheimer's disease and related dementias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Tailored Lighting Intervention on Sleep Quality, Rest-Activity, Mood, and Behavior in Older Adults With Alzheimer Disease and Related Dementias: A Randomized Clinical Trial. Figueiro, MG., Plitnick, B., Roohan, C., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3553247/

Light Therapy and Alzheimer's Disease and Related ... Light therapy has been shown to improve rest/activity rhythms and sleep efficiency in persons with ADRD in some, but not all, studies, presumably through ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1064748123005171

The Effects of Light Therapy on Sleep, Depression ... This meta-analysis demonstrates that light therapy is effective in improving sleep, cognition, and decreasing depression and neuropsychiatric behaviors for PLWD ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0293977

The effect of light therapy on sleep disorders and ... Light therapy leads to significant improvement in sleep and psychobehavioral symptoms and is associated with relatively fewer side effects in patients with AD.

4. alzheimers.org.uk alzheimers.org.uk/about-dementia/treatments/alternative-therapies/light-therapy-and-dementia

Light therapy and dementia A large and well-conducted research review found that bright light therapy can result in less daytime sleeping and increased night-time sleeping. Current ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05655195

Chronic Treatment of Alzheimer's Disease by Gamma Light ... For the present study, 60 participants with mild Alzheimer's disease will be enrolled and will use this light and sound device at-home daily for 6-months.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1041610224025511

Bright light therapy for agitation in dementia: a randomized ... Ancoli-Israel S. Increased light exposure consolidates sleep and strengthens circadian rhythms in severe Alzheimer's disease patients. Behavioral Sleep ...

7. tandfonline.com tandfonline.com/doi/full/10.2144/fsoa-2023-0155

Full article: Unleashing light's healing power: an overview ... The key findings of this study likely suggest that bright light therapy may have a positive effect on the rest-activity rhythms of Alzheimer's patients, and the ...