| Literature DB >> 35513978 |
Massimiliano de Zambotti1, Luca Menghini2, Michael A Grandner3, Susan Redline4, Ying Zhang5, Meredith L Wallace6, Orfeu M Buxton7.
Abstract
New sleep technologies have become pervasive in the consumer space, and are becoming highly common in research and clinical sleep settings. The rapid, widespread use of largely unregulated and unstandardized technology has enabled the quantification of many different facets of sleep health, driving scientific discovery. As sleep scientists, it is our responsibility to inform principles and practices for proper evaluation of any new technology used in the clinical and research settings, and by consumers. A current lack of standardized methods for evaluating technology performance challenges the rigor of our scientific methods for accurate representation of the sleep health facets of interest. This special article describes the rationale and priorities of an interdisciplinary effort for rigorous, standardized, and rapid performance evaluation (previously, "validation") of new sleep and sleep disorders related technologies of all kinds (eg, devices or algorithms), including an associated article template for a new initiative for publication in Sleep Health of empirical studies systematically evaluating the performance of new sleep technologies. A structured article type should streamline manuscript development and enable more rapid writing, review, and publication. The goal is to promote rapid and rigorous evaluation and dissemination of new sleep technology, to enhance sleep research integrity, and to standardize terminology used in Rigorous Performance Evaluation papers to prevent misinterpretation while facilitating comparisons across technologies.Entities:
Keywords: Actigraphy; Algorithms; Machine learning; Performance evaluations; Sensors; Wearables
Mesh:
Year: 2022 PMID: 35513978 PMCID: PMC9338437 DOI: 10.1016/j.sleh.2022.02.006
Source DB: PubMed Journal: Sleep Health ISSN: 2352-7218
| Priority | Description |
|---|---|
| Sleep metrics | Improved and standardized approaches to the definition of sleep intervals (ie, when deliberate sleep opportunities exist, such as times in and out of bed). Improved detail regarding performance of technology to determine when sleep opportunities exist (eg, when individuals are in or out of bed and/or attempting to sleep) with and/or without user input. |
| Improved and standardized approaches to the classification of sleep continuity variables, including time in and out of bed, sleep latency, awakenings, wake time after sleep onset, etc | |
| Improved and standardized approaches to the classification of sleep stages. | |
| Improved characterizations of daytime sleep, unintended sleep, and/or naps, including differentiation between sedentary behavior and sleep and specification for timing and duration criteria in the classification of naps whether intentional or unintentional. | |
| Oxygen desaturation and sleep-related breathing, particularly in at-home settings. | |
| Study populations | Evaluations in populations where activity patterns and relationships between activity and other physiological measures may vary from “young healthy adults” that are routinely included in studies. |
| Example priority populations include individuals with pacemakers, those undergoing medical treatments affecting motion and/or cardiovascular hemodynamics, people with physical (eg, back injury) and mental (eg, depressive disorders) conditions and sleep disorders (eg, restless legs syndrome, narcolepsy, insomnia disorder, sleep disordered breathing), individuals from underrepresented cultural backgrounds, individuals with atypical sleep-wake patterns (eg, nursing home residents, shift workers), individuals with atypical sleeping arrangements (eg, people who don’t sleep in a bed). | |
| Characteristics and/or confounders | Exploration of the role of contextual factors on measurement properties, including sex-specific variables (eg, menstrual cycle effects on sleep, or on primary data for algorithm development), age-related variables (eg, studies conducted during puberty, transition to nursing home), and other demographic variables (eg, race, ethnicity, skin color, body size), environmental variables (eg, temperature and light, seasonal changes). |
| Evaluations in conditions of pronounced variation in the targeted variable of interest (eg, accuracy of a sleep technology in measuring wake in condition of low and high sleep fragmentation). | |
| Evaluations under different conditions known to alter the physiological features used in sleep classification (eg, evaluating the impact of caffeine/alcohol consumption on performance). | |
| Examples of factors affecting sleep technology performance are outlined in de Zambotti et al.[ | |
| Data source | Evaluation of accuracy and reliability of raw signals derived from the sensors versus derived and/or summarized signals. |
| Unidimensional vs. multidimensional approaches to sleep and sleep event classification. | |
| Evaluation of outputs integrating multiple physiological measurements (eg, oxygen desaturation, heart rate variability [HRV]) to improve (and extend) activity-based measurements. |
Promoting standard definitions and operationalization of common performance outcome metrics.
In studies evaluating the performance of sleep technology, we frequently encounter inconsistency in the use of evaluation terminology. We define recommended and required elements in the use of a set of standardized terminology to address commonly “misused” language in the field of technology evaluation. Please refer to Menghini and colleagues[13] for a comprehensive discussion on the topic and a detailed description and operationalization of the key analytics and outcomes. We recognize that the field is fluid. We will update our Guide for Authors and Template as these metrics and methods evolve.
Talking to industry. What do we need to know?
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| – Raw data are still largely unavailable. |
| – The frequent undisclosed/proprietary nature of algorithms has limited their evaluation and use. |
| – Undisclosed updates and/or no control of this versioning process disrupts research and classifier development, and further limits their dissemination and adoption. |
| – Unclear claims regarding wellness / diagnostics / therapeutics are reflected in a lack of clear outcomes. |
| – Peer review should be preferred to company-internal public press. |
| – Importance of implementation, including access to application programming interfaces (APIs), research-level access to data, availability of real-time data |
| – Privacy considerations, including ability to de-identify data, avoid deductive re-identification, etc |
| Team members | Expertise | Link to Publications |
|---|---|---|
| Dr. de Zambotti is a Principal Scientist at SRI International and an expert in wearable sleep technology. He has been involved in several initiatives and international collaborations to investigate the performance, standardization, informed use, and regulation of sleep technology. Of relevance, he co-authored the position statement following the “ |
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| Dr. Menghini is a postdoctoral research fellow at University of Bologna working on the development and improvement of innovative methods in occupational health and sleep assessment, particularly focusing on Ecological Momentary Assessment designs. Having evaluated the performance of several multi-sensor wearable devices for both diurnal and nocturnal psychophysiological, he has recently proposed an R-based analytical pipeline for evaluating consumer sleep technologies. |
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| Dr. Grandner is the Director of the Sleep and Health Research Program at the University of Arizona College of Medicine and the Behavioral Sleep Medicine Clinic at the Banner-University Medical Center in Tucson, Arizona. He is Associate Professor of Psychiatry, Medicine, Psychology, Nutritional Sciences, and Clinical Translational Science. His research has focused on real-world implications of sleep health, including the development, evaluation, and implementation of sleep health technology. |
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| Dr. Susan Redline is the Farrell Professor of Sleep Medicine, Harvard Medical School, and Director of the Program in Sleep Medicine Epidemiology at Harvard Medical School. She has directed multiple large cohorts and clinical trials and co-directs the National Sleep Research Resource, a NIH funded sleep data repository that shares about 2TB of sleep data per week to the greater community. |
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| Dr. Ying Zhang is a data scientist is a Data Scientist for the National Sleep Research Resource (NSRR), a NHLBI-data and tool resource repository offering free access to large collection of polysomnography, actigraphy and other phenotype data at Brigham and Women’s Hospital. She is currently leading the data harmonization and metadata standards development at the NSRR. Prior to joining Brigham and Women’s Hospital, Dr. Zhang led data collection, harmonization, as well as construction and management of a consortium database of multiple national cohorts at the Harvard/MGH Center on Genomics, Vulnerable Populations, and Health Disparities. Dr. Zhang has previously worked as a research fellow at various non-profit organizations including the National Academy of Medicine, specialized in data modeling and visualization to inform policy decisions. |
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| Dr. Wallace is a biostatistician and Associate Professor of Psychiatry, Statistics, and Biostatistics at the University of Pittsburgh. With funding from the National Institute on Aging, her primary research program is focused on developing, adapting, and applying state-of-the-art machine learning approaches to determine which dimensions of multidimensional sleep health predict mental and physical health outcomes in older adults. Through this work, she harmonizes data across cohorts to perform rigorous external evaluations of predictive algorithms. In addition, Dr. Wallace is a statistical co-investigator on several studies evaluating the use of machine learning for improving sleep-related technologies. |
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| Dr. Buxton, Elizabeth Fenton Susman Professor of Biobehavioral Health at Penn State, directs the Sleep, Health, & Society Collaboratory. His completed and ongoing interdisciplinary studies in free-living humans of all ages address sleep health and wellbeing across the life course, with sleep usually measured by wearable devices. In addition to extensive experience with large-scale, longitudinal studies, he has co-authored device, algorithm, and machine learning algorithm evaluations. |
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