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 uses special blue and red lights that either flicker regularly or randomly. It aims to see how these lights affect sleep and cognitive functions in general participants. Blue light helps regulate the body clock, and the flickering might have additional effects.

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.

What safety data exists for light therapy in Alzheimer's treatment?

The safety data for light therapy in Alzheimer's treatment is limited and varies across studies. A pilot study using light visors found no consistent biological effects, possibly due to insufficient light exposure or advanced stages of Alzheimer's. Another study highlighted the potential of light therapy to regulate sleep-wake patterns in dementia patients, but methodological issues were noted. A review of light therapy studies indicated poor methodological quality, suggesting the need for better lighting descriptions and involvement of light specialists. Overall, while light therapy is established for other conditions like Seasonal Affective Disorder, its safety and efficacy in Alzheimer's require further investigation. ^{1 2 3 4 5}

Is Rhythmic Light Therapy a promising treatment for Alzheimer's Disease?

Yes, Rhythmic Light Therapy is promising for Alzheimer's Disease. It can improve sleep, reduce agitation, and help with depression. It is a non-drug option that uses light to help manage symptoms. ^{1 2 6 7 8}

What data supports the idea that Light Therapy for Alzheimer's Disease is an effective treatment?

The available research shows that Light Therapy can be effective for people with Alzheimer's Disease. For example, using a self-luminous light table increased sleep quality and reduced agitation and depression. Another study found that tailored lighting improved sleep, mood, and behavior in people with Alzheimer's. However, one study using light visors did not find consistent improvements, possibly due to issues like the timing or method of light delivery. Overall, Light Therapy seems promising, especially when the light is delivered in a way that aligns with the body's natural rhythms. ^{1 2 6 8 9}

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.

Residence in a skilled nursing facility or long-term care

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

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]

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]

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]

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]

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]

Citations

1. United States 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. [2023]

2. New Zealand 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. [2022]

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

Phototherapy for patients with Alzheimer disease with disturbed sleep patterns: results of a community-based pilot study. [2019]

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

Tailored Lighting Intervention for Persons with Dementia and Caregivers Living at Home. [2022]

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

Research Note: A self-luminous light table for persons with Alzheimer's disease. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Effect of morning bright light treatment for rest-activity disruption in institutionalized patients with severe Alzheimer's disease. [2019]

7. 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]

8. Switzerland pubmed.ncbi.nlm.nih.gov

CME: Light Therapy: Why, What, for Whom, How, and When (And a Postscript about Darkness). [2022]

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

Actigraphy for Assessing Light Effects on Sleep and Circadian Activity Rhythm in Alzheimer's Dementia: A Narrative Review. [2020]