Light Therapy for Alzheimer's Disease
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Icahn School of Medicine at Mount Sinai
Must not be taking: Sleep medication
Disqualifiers: Severe sleep apnea, Epilepsy, others
Trial Summary
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 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.12345
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.35678
Eligibility Criteria
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
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Trial Timeline
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
Treatment Details
Interventions
- Rhythmic Light Therapy (Behavioural Intervention)
Trial OverviewThe 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.
Participant Groups
4Treatment groups
Active Control
Placebo Group
Group I: Placebo Light plus Active RhythmActive Control2 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 RhythmActive Control2 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 RhythmActive Control2 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 RhythmPlacebo Group2 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Icahn School of Medicine at Mount SinaiNew York, NY
Light and Health Research CenterMenands, NY
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Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
References
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]We investigated the effectiveness of a lighting intervention tailored to maximally affect the circadian system as a nonpharmacological therapy for treating problems with sleep, mood, and behavior in persons with Alzheimer disease and related dementias (ADRD).
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]Light therapy has shown great promise as a nonpharmacological method to improve symptoms associated with Alzheimer's disease and related dementias (ADRD), with preliminary studies demonstrating that appropriately timed light exposure can improve nighttime sleep efficiency, reduce nocturnal wandering, and alleviate evening agitation. Since the human circadian system is maximally sensitive to short-wavelength (blue) light, lower, more targeted lighting interventions for therapeutic purposes, can be used.
Phototherapy for patients with Alzheimer disease with disturbed sleep patterns: results of a community-based pilot study. [2019]We examined the entraining effects of phototherapy delivered by light visors on disturbed sleep patterns of community-dwelling research subjects with Alzheimer disease (AD). The pilot project used a single subject design and activity monitoring as the primary outcome measures. The protocol consisted of a 5-day baseline monitoring period, followed by 10 consecutive days of phototherapy (2,000 lux of full spectrum bright light) delivered by light visors for 2 hours each morning; this was followed by an additional 14 days of activity monitoring. Cosinor analyses found no consistent changes in acrophase, mesor, or amplitude. Observed changes in acrophase were consistent with phase advancement of the rest-activity cycle and consistent with the biological intervention. Changes in the number of nighttime awakenings were not found. One subject had a significant increase in total sleep time, whereas another had a significant decrease in total sleep time. Failure to find a consistent biological effect of light on AD subjects may be secondary to: (1) insufficient duration of light exposure; (2) timing of light administration (given at a time when circadian rhythm is refractory to the effects of light); (3) advanced stages of AD making the Y circadian pacemaker in the suprachiasmatic nucleus of the hypothalamus insensitive to the biological effects of light; and (4) inadequacy of light visors as a means of providing light.
Research Note: A self-luminous light table for persons with Alzheimer's disease. [2020]Light can be used to consolidate sleep in individuals with Alzheimer's disease and related dementias, but the light delivery method is one of the greatest challenges for successful treatment. Based on our field observations, it was hypothesised that a self-luminous light table would be a practical way to deliver light because persons with Alzheimer's disease typically spend a significant amount of time sitting at tables. Compared to a baseline week, sleep percent and efficiency significantly increased and agitation and depression scores significantly decreased during the four intervention weeks. The self-luminous light table was an effective and practical method to deliver circadian-effective light to persons with Alzheimer's disease.
Tailored Lighting Intervention for Persons with Dementia and Caregivers Living at Home. [2022]Light therapy has shown promise as a nonpharmacological treatment to help regulate abnormal sleep-wake patterns and associated behavioral issues prevalent among individuals diagnosed with Alzheimer's disease and related dementia (ADRD). The present study investigated the effectiveness of a lighting intervention designed to increase circadian stimulation during the day using light sources that have high short-wavelength content and high light output.
Effect of morning bright light treatment for rest-activity disruption in institutionalized patients with severe Alzheimer's disease. [2019]Disturbances in rest-activity rhythm are prominent and disabling symptoms in Alzheimer's disease (AD). Nighttime sleep is severely fragmented and daytime activity is disrupted by multiple napping episodes. In most institutional environments, light levels are very low and may not be sufficient to enable the circadian clock to entrain to the 24-hour day. The purpose of this randomized, placebo-controlled, clinical trial was to test the effectiveness of morning bright light therapy in reducing rest-activity (circadian) disruption in institutionalized patients with severe AD.
Shedding a Light on Phototherapy Studies with People having Dementia: A Critical Review of the Methodology from a Light Perspective. [2018]Light therapy is applied to older people with dementia as a treatment to reset the biological clock, to improve the cognitive functioning, and to reduce behavioral symptoms. Although the methodological quality of light therapy studies is essential, many aspects concerning the description of the lighting applied are missing. This study reviewed light therapy studies concerning the effects on people with dementia as a way to check the methodological quality of the description of light from a light engineering perspective. Twelve studies meeting the inclusion criteria were chosen for further analysis. Each study was scored on a list of aspects relevant to a proper description of lighting aspects. The overview demonstrates that the overall quality of the methodologies is poor. The studies describe the lighting insufficiently and not in the correct metrics. The robustness of light therapy studies can be improved by involving a light engineer or specialist.
CME: Light Therapy: Why, What, for Whom, How, and When (And a Postscript about Darkness). [2022]Light therapy has become established as an evidence-based treatment for Seasonal Affective Disorder. Light impacts the timing and stability of circadian rhythms as expressed in sleep, mood, alertness, and cognition. Forty years of clinical trials and open treatment have led to guidelines for patient selection, using light alone or in combination with antidepressants (or lithium for bipolar depression). Mood and sleep disturbances can also respond to adjunct light therapy in a broader set of psychiatric, neurologic and medical illnesses. We specify criteria for choice of treatment devices: optimum dose (10,000 lux), spectrum (white light), exposure duration (30-60 minutes) and timing (early morning). Protocol adjustment requires continual monitoring with attention to rate of improvement and management of potential side effects.
Actigraphy for Assessing Light Effects on Sleep and Circadian Activity Rhythm in Alzheimer's Dementia: A Narrative Review. [2020]Alzheimer's Disease (AD) is often accompanied by severe sleep problems and circadian rhythm disturbances which may to some extent be attributed to a dysfunction in the biological clock. The 24-h light/dark cycle is the strongest Zeitgeber for the biological clock. People with AD, however, often live in environments with inappropriate photic Zeitgebers. Timed bright light exposure may help to consolidate sleep- and circadian rest/activity rhythm problems in AD, and may be a low-risk alternative to pharmacological treatment.