Tailored Light Treatment for Dementia
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 65+
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, Melatonin
Disqualifiers: Brain vascular disease, Parkinson's, others
Trial Summary
What is the purpose of this trial?
Aim 2 will investigate the effect of 3 different light exposure lengths on sleep, mood and agitation in persons with Alzheimer's disease. Participants will be randomly assigned to one of three conditions of light exposure: 1) 2-h morning light exposure; 2) 4-h morning light exposure; and 3) all day light exposure.
Will I have to stop taking my current medications?
The trial requires that participants do not use sleep medication or oral melatonin, so you would need to stop these if you are currently taking them.
What data supports the effectiveness of the treatment Tailored Light Treatment for Dementia?
Is light therapy safe for people with dementia?
How is the Active Lighting Intervention treatment different from other treatments for dementia?
Active Lighting Intervention, or light therapy, is unique because it uses bright light exposure to help reset the biological clock and improve behavioral symptoms in people with dementia, unlike traditional treatments that often rely on medication. This non-drug approach focuses on influencing circadian rhythms, which are often disrupted in dementia patients, by providing timed light exposure to improve activity rhythms and reduce agitation.12489
Eligibility Criteria
This trial is for individuals with Alzheimer's or related dementia, who have a Montreal Cognitive Assessment score below 25 and sleep disturbances indicated by a Pittsburgh Sleep Quality Index score of 5 or higher. It excludes those with major brain conditions, severe eye problems, use of sleep medication or melatonin, untreated sleep apnea, or severe restless leg syndrome.Inclusion Criteria
I have Alzheimer's or similar dementia with a low cognitive score.
I have trouble sleeping, scoring 5 or more on a sleep quality test.
Exclusion Criteria
I have severe vision loss due to macular degeneration.
I use medication to help me sleep.
I have severe restless leg syndrome.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomly assigned to one of three light exposure conditions: 2-h morning, 4-h morning, or all day light exposure
14 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Active Lighting Intervention (Behavioural Intervention)
- Control Lighting Intervention (Behavioural Intervention)
Trial OverviewThe study tests how different durations of morning light exposure affect the sleep quality, mood, and agitation levels in people with Alzheimer's disease. Participants will be randomly placed into groups receiving either 2 hours of morning light, 4 hours of morning light, or all-day light exposure.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Active Lighting InterventionActive Control2 Interventions
Lighting intervention designed to effect the circadian system then will receive the control lighting intervention.
Group II: Control Lighting InterventionPlacebo Group1 Intervention
Lighting intervention using low light levels designed to not effect the circadian system
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Icahn School of Medicine at Mount SinaiAlbany, NY
Icahn School of Medicine at Mount SinaiNew York, NY
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Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
References
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]To evaluate the effects of light therapy on the alleviation of sleep disturbances, agitation and depression in people with dementia.
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.
Impact of ambient bright light on agitation in dementia. [2022]To evaluate the effect of ambient bright light therapy (BLT) on agitation among institutionalized persons with dementia.
Improvement in behavioral symptoms and advance of activity acrophase after short-term bright light treatment in severe dementia. [2022]Ten elderly subjects with severe dementia were given bright light (5000-8000 lux) for 45 min each morning for 4 weeks. Two rating scales of behavioral symptoms in dementia were used as outcome measures: Cohen-Mansfield Agitation Inventory (CMAI) and Behavior Pathology In Alzheimer's Disease Rating Scale (BEHAVE-AD), a scale for sleep-wake disturbances, and actigraphy to monitor activity rhythm. Behavioral symptoms improved with treatment. No changes in sleep-wake measures were found. There was an advance of the activity rhythm acrophase during treatment. These results suggest that short-time bright light improves behavioral symptoms and aspects of activity rhythm disturbances even in severely demented subjects.
Transcranial Near Infrared Light Stimulations Improve Cognition in Patients with Dementia. [2021]Dementia is a complex syndrome with various presentations depending on the underlying pathologies. Low emission of transcranial near-infrared (tNIR) light can reach human brain parenchyma and be beneficial to a number of neurological and neurodegenerative disorders. We hereby examined the safety and potential therapeutic benefits of tNIR light stimulations in the treatment of dementia. Patients of mild to moderate dementia were randomized into active and sham treatment groups at 2:1 ratio. Active treatment consisted of low power tNIR light stimulations with an active photobiomodulation for 6 min twice daily during 8 consequent weeks. Sham treatment consisted of same treatment routine with a sham device. Neuropsychological battery was obtained before and after treatment. Analysis of variance (ANOVA) was used to analyze outcomes. Sixty subjects were enrolled. Fifty-seven subjects completed the study and had not reported health or adverse side effects during or after the treatment. Three subjects dropped out from trial for health issues unrelated to use of tNIR light treatment. Treatment with active device resulted in improvements of cognitive functions and changes were: an average increase of MMSE by 4.8 points; Logical Memory Tests I and II by ~3.0 points; Trail Making Tests A and B by ~24%; Boston Naming Test by ~9%; improvement of both Auditory Verbal Learning Tests in all subtest categories and overall time of performance. Many patients reported improved sleep after ~7 days of treatment. Caregivers noted that patients had less anxiety, improved mood, energy, and positive daily routine after ~14-21 days of treatment. The tNIR light treatments demonstrated safety and positive cognitive improvements in patients with dementia. Developed treatment protocol can be conveniently used at home. This study suggests that additional dementia treatment trials are warranted with a focus on mitigating caregivers' burden with tNIR light treatment of dementia patients.
Application of light therapy in older adults with cognitive impairment: A systematic review. [2021]This systematic review aims to assess the efficacy of light therapy on behavioural and psychological symptoms of dementia (BPSD), cognition, functional status, and quality of life in older adults with cognitive impairment; and secondarily, to identify the optimal characteristics of light therapy to establish an adequate protocol for its clinical application. We searched Web of Science and Medline databases through December 2019, resulting in 36 included articles: 3 evaluated the effects on BPSD, 25 on sleep, 12 on agitation, 10 on mood, 4 on neuropsychiatric symptoms, 4 on cognition, 2 on quality of life and 2 on functional status. Literature has shown potential evidence for positive effects of light therapy on managing sleep, behavioural and mood disturbances in people with cognitive impairment, but a limited effect on cognition, quality of life and functional status. This review provides guidelines for intervention protocols with light therapy in older people with cognitive impairment.
Light therapy for behavioural and psychological symptoms of dementia. [2015]To review literature concerning the efficacy, clinical practicability and safety of light treatment for behavioural and psychological symptoms of dementia (BPSD).
The Effect of Bright Light Treatment on Rest-Activity Rhythms in People with Dementia: A 24-Week Cluster Randomized Controlled Trial. [2021]Bright light treatment is an effective way to influence circadian rhythms in healthy adults, but previous research with dementia patients has yielded mixed results. The present study presents a primary outcome of the DEM.LIGHT trial, a 24-week randomized controlled trial conducted at nursing homes in Bergen, Norway, investigating the effects of a bright light intervention. The intervention consisted of ceiling-mounted LED panels providing varying illuminance and correlated color temperature throughout the day, with a peak of 1000 lx, 6000 K between 10 a.m. and 3 p.m. Activity was recorded using actigraphs at baseline and after 8, 16, and 24 weeks. Non-parametric indicators and extended cosine models were used to investigate rest-activity rhythms, and outcomes were analyzed with multi-level regression models. Sixty-one patients with severe dementia (median MMSE = 4) were included. After 16 weeks, the acrophase was advanced from baseline in the intervention group compared to the control group (B = -1.02, 95%; CI = -2.00, -0.05). There was no significant difference between the groups on any other rest-activity measures. When comparing parametric and non-parametric indicators of rest-activity rhythms, 25 out of 35 comparisons were significantly correlated. The present results indicate that ambient bright light treatment did not improve rest-activity rhythms for people with dementia.
Light Intervention Effects on Circadian Activity Rhythm Parameters and Nighttime Sleep in Dementia Assessed by Wrist Actigraphy: A Systematic Review and Meta-Analysis. [2022]Persons with dementia often show circadian rhythm disturbances and sleep problems. Timed light exposure seems to be a promising nonpharmacological treatment option. In this review, meta-analyses were run on light effects on circadian activity rhythm parameters in persons with dementia measured with wrist actimetry. Furthermore, we update a Cochrane review, published in 2014, on actigraphically measured light effects in nighttime sleep parameters in persons with dementia.