SBIR-STTR Award

Device to Measure Circadian-Effective Light in Alzheimer's Disease Environments
Award last edited on: 11/17/2023

Sponsored Program
SBIR
Awarding Agency
NIH : NIA
Total Award Amount
$6,004,066
Award Phase
2
Solicitation Topic Code
866
Principal Investigator
Erik Page

Company Information

Erik Page & Associates Inc

34 Buena Vista Avenue
Fairfax, CA 94930
   (415) 448-6575
   N/A
   www.erikpage.com
Location: Single
Congr. District: 02
County: Marin

Phase I

Contract Number: 1R43AG060857-01
Start Date: 9/15/2018    Completed: 5/31/2019
Phase I year
2018
Phase I Amount
$225,000
This proposed project will develop and field-test a device that accurately monitors and controls the circadian stimulus (CS) for Alzheimer disease (AD) and Alzheimer-disease-related dementia (ADRD) patients in nursing homes. Human biology has evolved to have two distinct optical systems: the visual system, by which we see and process images, and the circadian system, which regulates our biological clock and associated biological systems. These two systems have significantly different spectral and temporal responses to optical input. Specifically, circadian stimulation peaks at 460 nm and responds after several minutes of optical activation, while the visual system peaks at 555 nm and responds nearly instantaneously to inputs. While a broad and growing body of research has documented the impacts the circadian system has on human health, including regulating sleep and improving cognition in AD/ADRD patients, research on the CS experienced by AD/ADRD patients is extremely limited. All lighting systems are designed and installed in buildings with consideration only given to the photopic (visual) system and all light meters used to characterize lighting buildings are calibrated to measure photopic light, not CS. Researchers at the Lighting Research Center at Rensselaer Polytechnic Institute developed the Daysimeter, a calibrated light meter that measures circadian light and circadian stimulus. In the proposed project, researchers would modify an existing workstation-based lighting control system they previously developed for the visual system to include Daysimeter technology. This modified lighting controller would include the all the necessary sensors and components to monitor and control both circadian and photopic light and exposure to CS. Data from these devices would be wirelessly transmitted to researchers via an Internet gateway and associated cloud-based data management systems. These data would be of immediate value for gaining a better understanding of AD/ADRD patients' CS exposure and could ultimately result in new lighting systems and/or building codes that consider both our visual and circadian systems. After these modifications are completed and the devices are shown to accurately record CS in the laboratory, 20 prototype devices would be deployed in AD/ADRD nursing homes for one month. Data from these devices, other measurements made at the field site, and assessments of AD/ADRD patient sleep patterns, sleepiness, and depression would be collected. A final report would be prepared that includes: 1) recommendations for modifications to the device (if needed), 2) a discussion of correlations between measured CS and patient sleep, sleepiness and depression and, 3) plans for large field test deployment in Phase II.

Project Terms:
Affect; Agitation; alertness; Alzheimer's Disease; Assisted Living Facilities; awake; base; Behavior; Biological Clocks; biological systems; Brain; Building Codes; Characteristics; circadian pacemaker; Circadian Rhythms; Clinical; cloud based; Cognition; commercialization; Controlled Environment; cost; Data; Data Collection; Database Management Systems; Dementia; design; Device Designs; Devices; Dose; Drowsiness; Effectiveness; Elderly; Environment; Evaluation; experience; Exposure to; falls; Family; Family Caregiver; Fatigue; field study; Health; Home environment; Hour; Human; Human Biology; Image; improved; Institutes; interest; Internet; Intervention; Knowledge; Laboratories; Light; Lighting; loved ones; Measurement; Measures; Mental Depression; meter; Modification; Monitor; Moods; Nursing Homes; Optics; Patients; Pattern; Performance; Persons; Phase; Phototherapy; Physiology; Planet Earth; Population; Precipitating Factors; Process; product development; prototype; Recommendation; Reporting; Research; Research Personnel; residence; response; Retina; Retinal; Rotation; Running; safety and feasibility; safety testing; sensor; Site; Sleep; Sleep disturbances; Stimulus; Stress; success; System; Technology; Testing; therapy design; Time; Training; Vision; Visual; Visual system structure; Wakefulness; Wireless Technology; Work;

Phase II

Contract Number: 2R44AG060857-02
Start Date: 9/15/2018    Completed: 6/30/2021
Phase II year
2019
(last award dollars: 2023)
Phase II Amount
$5,779,066

This proposed project will develop and field-test a device that accurately monitors and controls the circadian stimulus (CS) for Alzheimer disease (AD) and Alzheimer-disease-related dementia (ADRD) patients in nursing homes. Human biology has evolved to have two distinct optical systems: the visual system, by which we see and process images, and the circadian system, which regulates our biological clock and associated biological systems. These two systems have significantly different spectral and temporal responses to optical input. Specifically, circadian stimulation peaks at 460 nm and responds after several minutes of optical activation, while the visual system peaks at 555 nm and responds nearly instantaneously to inputs. All lighting systems are designed and installed in buildings with consideration only given to the photopic (visual) system and all light meters used to characterize lighting buildings are calibrated to measure photopic light, not CS. While a broad and growing body of research has documented the impacts of the circadian system on human health, including regulating sleep and improving cognition in AD/ADRD patients, research on the CS experienced by AD/ADRD patients is extremely limited. Researchers at the Lighting Research Center at Rensselaer Polytechnic Institute developed the Daysimeter, a calibrated light meter that measures circadian light and circadian stimulus. In Phase I of this project, researchers modified an existing workstation-based lighting control system they previously developed for the visual system to include Daysimeter technology, allowing this control system to record CS measurements. The accuracy of these CS measurements was confirmed in the laboratory and field-testing of 20 of devices is currently ongoing in AD/ADRD nursing homes. In this Phase II application, researchers propose adding control features to this device so that lighting can be controlled to optimize CS dosages in AD/ADRD patient environments. Machine learning-based lighting control algorithms will be driven by continuous light level and spectrum measurements as well as periodic (e.g., daily) patient health data. Data from these devices would be wirelessly transmitted to researchers via an Internet gateway and associated cloud-based data management systems. These data would be of immediate value for gaining a better understanding of AD/ADRD patients' CS exposure and could ultimately result in new lighting systems and/or building codes that consider both our visual and circadian systems. Following the development phase, 30 CS-enabled lighting control systems will be field tested over a 22-week test period. Researchers aim to commercialize this CS-enabled lighting control system shortly after the completion of this field test and the Phase II project specifically targeting AD/ADRD nursing home applications.

Public Health Relevance Statement:
Project Narrative A growing body of research has demonstrated how light impacts human circadian systems and how these impacts can affect sleep, alertness, cognition and agitation in people with Alzheimer's disease (AD) and Alzheimer's-disease-related dementia (ADRD). Still, significant knowledge gaps exist in determining how much circadian stimulation is typically provided to AD/ADRD patients and there are no commercial products designed to control lighting in AD/ADRD environments in ways that promote circadian-related health. This project aims to fill in these gaps by developing and testing a device specifically designed to measure and control the circadian stimulation experienced by AD/ADRD patients in nursing homes.

Project Terms:
active control; Affect; Agitation; alertness; Algorithms; Alzheimer's Disease; Alzheimer's disease related dementia; appropriate dose; awake; Back; base; Behavior; Biological Clocks; biological systems; Building Codes; Characteristics; circadian; circadian pacemaker; Clinical Trials; cloud based; Cognition; commercialization; Data; Database Management Systems; design; Development; Device or Instrument Development; Devices; dosage; Dose; Effectiveness; Elderly; Environment; experience; falls; feeding; Feeds; field study; Health; health data; Hour; Human; Human Biology; Image; improved; Institutes; interest; Internet; Intervention; Knowledge; Laboratories; Light; Lighting; Machine Learning; Measurement; Measures; meter; Monitor; Moods; next generation; novel; Nursing Homes; Optics; Patients; Pattern; Performance; Periodicity; Phase; Phototherapy; Planet Earth; Population; Process; prototype; Reporting; Research; Research Personnel; residence; response; Retina; Rotation; Running; Sleep; Stimulus; success; System; Technology; Testing; therapy design; Time; Vision; Visual; Visual system structure; Wakefulness; Wireless Technology; Work