SBIR-STTR Award

Real-world translation of a dynamic and personalized intervention for shift workers
Award last edited on: 2/2/2025

Sponsored Program
SBIR
Awarding Agency
NIH : NHLBI
Total Award Amount
$948,310
Award Phase
2
Solicitation Topic Code
837
Principal Investigator
Olivia Walch

Company Information

Arcascope LLC

14150 Parkeast Circle Suite 140
Chantilly, VA 20151
   (703) 328-0848
   N/A
   www.arcascope.com
Location: Single
Congr. District: 11
County: Fairfax

Phase I

Contract Number: 1R41HL163783-01A1
Start Date: 4/1/2022    Completed: 11/30/2023
Phase I year
2022
Phase I Amount
$254,877
Shift workers experience profound circadian disruption, which can have deleterious long term effects on theirhealth and quality of life. Mood, fatigue, and performance can be improved in shift workers by moving thetiming of their peak circadian drive to sleep outside the hours they are expected to work. This can be achievedwith a targeted lighting intervention, as light is the primary input to the body's circadian clock. Crafting such anintervention for an individual, however, requires knowledge of the person's starting circadian state, which hastraditionally been hard to assess in shift workers. The gold standard measure of circadian timing is dim lightmelatonin onset, or DLMO. For day workers, DLMO most commonly occurs in a six hour window prior tohabitual bedtime. For fixed night shift workers, however, DLMO can occur anytime over the 24-hour day. Thisrequires 24 hours of melatonin collection in order to arrive at a single indicator of internal time, which is oftenprohibitively time consuming and expensive. Recently, we have developed new techniques for noninvasively predicting circadian timing throughconsumer wearable devices (e.g. Apple Watch). These techniques can predict DLMO timing to within 2 hoursfor more than three-quarters of shift workers working night shifts. The PIs of this grant have also developedmathematical techniques for generating lighting recommendations based on predicted circadian timing, aimedat shifting the peak circadian drive to sleep outside the window of working hours. In this Phase I STTR, we propose to develop an iOS mobile application for shift workers, to both tracktheir circadian state and to make recommendations for how they can expose themselves to light to feel betterand reduce the long term negative health impacts of shift work. We will design the app based on interviewswith shift workers in an iterative process. Twenty-five shift workers will be recruited to be in a usability trialassessing the app. We will have them wear an Apple Watch for one week prior to the start of the usability trialto collect baseline data, and we will collect DLMO at the conclusion of that week. For two weeks after collectionof DLMO, we will have them interact with the mobile app, including following the recommendations it makesand documenting their compliance with the recommendations. At the conclusion of the trial, we will ask for theirfeedback on the app in order to improve the algorithms and make updates to the design. Ultimately, an app of this kind could interface with home and workplace smart lighting systems, couldinform employer scheduling decisions, and could be used to increase retention in critical shift work professionswhile reducing the negative health impacts of night shifts on workers.

Public Health Relevance Statement:
PROJECT NARRATIVE Shift workers experience significant disruption to their internal clocks, which has marked effects on their health and quality of life. Lighting interventions hold promise for improving mood, fatigue, and performance in night shift workers. In this project, we will develop a mobile app for shift workers that provides lighting and behavioral recommendations, and assess its user experience in a usability trial at the Henry Ford Health System.

Project Terms:

Phase II

Contract Number: 2R42HL163783-02
Start Date: 4/1/2022    Completed: 6/30/2027
Phase II year
2024
Phase II Amount
$693,433
Shift workers experience profound circadian disruption, which can have deleterious long term effects on their health and quality of life. Due to the necessity of night shift work for 24-7 continuous operations and safety, it is urgent that society prioritize ways to support shift worker health. Mood, fatigue, and performance can be improved in shift workers by shifting the timing of production of the hormone melatonin outside the hours they are expected to work. This can be achieved with a targeted lighting intervention, as light is the primary input to the body's circadian clock, and supported by behavioral interventions, including meal and exercise timing. Crafting such an intervention for an individual, however, requires knowledge of the person's current biological time, or circadian state, which has traditionally been extremely challenging to assess in shift workers. The gold standard measure of circadian timing is dim light melatonin onset, or DLMO. For day workers, DLMO most commonly occurs in a six hour window prior to habitual bedtime. For fixed night shift workers, however, DLMO can occur anytime over the 24-hour day. This requires 24 hours of melatonin collection in order to arrive at a single indicator of internal time, which is often prohibitively time consuming and expensive. The small business on this proposal, Arcascope, has developed new techniques for noninvasively predicting circadian timing through consumer wearable devices (e.g. Apple Watch) in collaboration with research partner organization Henry Ford. These techniques can accurately predict DLMO timing in shift working adults using consumer wearable devices. The PIs of this grant have also developed mathematical techniques for generating lighting recommendations based on predicted circadian timing, aimed at shifting the peak circadian drive to sleep outside the window of working hours. These techniques have been evaluated in a Phase I STTR, through the deployment of an iOS mobile app, SHIFT, which achieved large phase shifts in real world night shift workers, demonstrating that it is possible to shift their circadian rhythms so that the melatonin secretion occurs outside their working hours. The next step in this work is to move beyond feasibility and towards effectiveness and implementation. In particular, it remains to be demonstrated that the mobile app can produce meaningful changes in stakeholder-centered outcomes in large, rigorously tested cohorts. These outcomes include not only worker health outcomes, such as depression and sleep health, but also quantities of critical import to their employers finances, including worker turnover, safety, and health coverage costs. In this Phase II project, we propose to evaluate how the SHIFT app can affect these outcomes, demonstrate noninferiority of an Android version, and assess key facilitators and barriers to engagement and implementation.

Public Health Relevance Statement:
NARRATIVE Shift workers experience significant disruption to their internal clocks, which has marked effects on their health and quality of life. Lighting interventions hold promise for improving mood, fatigue, and performance in night shift workers. In this project, we will conduct a study to better understand how our shift work solution can improve real-world outcomes for healthcare shift workers. Terms: <21+ years old; Actinotherapy; Adult; Adult Human; Affect; Android; Android App; Android Application; Apple watch; Award; Behavior Conditioning Therapy; Behavior Modification; Behavior Therapy; Behavior Treatment; Behavioral Conditioning Therapy; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Biological; Biological Clocks; Businesses; Cancers; Cardiovascular; Cardiovascular Body System; Cardiovascular Organ System; Cardiovascular system; Cell Phone Application; Cell phone App; Cellular Phone App; Cellular Phone Application; Cholesterol; Circadian Dysregulation; Circadian Rhythms; Circadian desynchrony; Clinical; Collaborations; Collection; Conditioning Therapy; Consumption; Control Groups; Data; Effectiveness; Emergency response; Employee Engagement; Endocrine Gland Secretion; Equity; Essential employee; Essential person; Essential personnel; Essential staff; Essential worker; Exercise; Exposure to; Fatigue; Feedback; Future; Goals; Grant; Health; Healthcare; Heart Vascular; Hormones; Hour; Illumination; Individual; Infrastructure; Intervention; Intervention Strategies; Interview; Knowledge; Lack of Energy; Left; Light; Light Therapy; Lighting; Long-Term Effects; Longterm Effects; Malignant Neoplasms; Malignant Tumor; Marketing; Math; Math Models; Mathematics; Medicine; Melatonin; Mental Depression; Mental disorders; Mental health disorders; Metabolic; Methods; Moods; Nyctohemeral Rhythm; Obesity; Outcome; Performance; Persons; Phase; Photoradiation; Photoradiation Therapy; Phototherapy; Physiologic; Physiological; Population; Production; Productivity; Psychiatric Disease; Psychiatric Disorder; Public Health; QOL; Qualitative Methods; Quality of life; Recommendation; Research; Research Resources; Resources; Risk; Route; STTR; Safety; Schedule; Series; Sleep; Sleep Deprivation; Small Business Technology Transfer Research; Smart Phone App; Smart Phone Application; Smartphone App; Societies; Structure; Techniques; Testing; Therapeutic Hormone; Time; Translations; Triacylglycerol; Triglycerides; Twenty-Four Hour Rhythm; Update; Waiting Lists; Work; adiposity; adulthood; applewatch; behavior intervention; behavioral intervention; biologic; body clock; care outcomes; cell phone based app; circadian; circadian abnormality; circadian clock; circadian desynchronization; circadian disruption; circadian disturbance; circadian dysfunction; circadian impairment; circadian misalignment; circadian pacemaker; circadian process; circulatory system; clinical applicability; clinical application; cohort; commercialization; comparative effectiveness; corpulence; cost; daily biorhythm; day shift; deficient sleep; depression; design; designing; evidence base; experience; global health; group intervention; health care; health care outcomes; healthcare outcomes; iOS app; iOS application; iPhone App; iPhone Application; improved; inadequate sleep; insufficient sleep; internal clock; interventional strategy; light intervention; light treatment; malignancy; mathematic model; mathematical model; mathematical modeling; mental illness; mobile app; mobile application; mobile device application; mobile phone app; neoplasm/cancer; night shift; night work; operation; operations; personalized health intervention; personalized intervention; poor health outcome; precision interventions; precision medicine; precision-based medicine; psychiatric illness; psychological disorder; qualitative reasoning; reduced health outcome; satisfaction; shift work; shiftwork; sleep debt; sleep deficiency; sleep deficit; sleep health; sleep hygiene; sleep insufficiency; sleep loss; smartphone application; smartphone based app; smartphone based application; social; standard measure; translation; waitlist; wearable; wearable device; wearable electronics; wearable system; wearable technology; wearable tool; wearables; worse health outcome