{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T12:39:22Z","timestamp":1793709562716,"version":"4.6.1"},"reference-count":129,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2024,3,14]],"date-time":"2024-03-14T00:00:00Z","timestamp":1710374400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clinical Trials"],"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:sec>\n                    <jats:title>Background\/Aims<\/jats:title>\n                    <jats:p>Information regarding the use of wearable devices in clinical research, including disease areas, intervention techniques, trends in device types, and sample size targets, remains elusive. Therefore, we conducted a comprehensive review of clinical research trends related to wristband wearable devices in research planning and examined their applications in clinical investigations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>As this study identified trends in the adoption of wearable devices during the planning phase of clinical research, including specific disease areas and targeted number of intervention cases, we searched ClinicalTrials.gov\u2014a prominent platform for registering and disseminating clinical research. Since wrist-worn devices represent a large share of the market, we focused on wrist-worn devices and selected the most representative models among them. The main analysis focused on major wearable devices to facilitate data analysis and interpretation, but other wearables were also surveyed for reference. We searched ClinicalTrials.gov with the keywords \u201cActiGraph,\u201d\u201cApple Watch,\u201d\u201cEmpatica,\u201d\u201cFitbit,\u201d\u201cGarmin,\u201d and \u201cwearable devices\u201d to obtain studies published up to 21 August 2022. This initial search yielded 3214 studies. After excluding duplicate National Clinical Trial studies (the overlap was permissible among different device types except for wearable devices), our analysis focused on 2930 studies, including simple, time-series, and type-specific assessments of various variables.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, an increasing number of clinical studies have incorporated wearable devices since 2012. While ActiGraph and Fitbit initially dominated this landscape, the use of other devices has steadily increased, constituting approximately 10% of the total after 2015. Observational studies outnumbered intervention studies, with behavioral and device-based interventions being particularly prevalent. Regarding disease types, cancer and cardiovascular diseases accounted for approximately 20% of the total. Notably, 114 studies adopted multiple devices simultaneously within the context of their clinical investigations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Our findings revealed that the utilization of wearable devices for data collection and behavioral interventions in various disease areas has been increasing over time since 2012. The increase in the number of studies over the past 3\u2009years has been particularly significant, suggesting that this trend will continue to accelerate in the future. Devices and their evaluation methods that have undergone thorough validation, confirmed their accuracy, and adhered to established legal regulations will likely assume a pivotal role in evaluations, allowing for remote clinical trials. Moreover, behavioral intervention therapy utilizing apps is becoming more extensive, and we expect to see more examples that will lead to their approval as programmed medical devices in the future.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17407745241230287","type":"journal-article","created":{"date-parts":[[2024,3,15]],"date-time":"2024-03-15T01:01:44Z","timestamp":1710464504000},"page":"470-482","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":11,"title":["Assessing the current utilization status of wearable devices in clinical research"],"prefix":"10.1177","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7952-862X","authenticated-orcid":false,"given":"Takashi","family":"Miyakoshi","sequence":"first","affiliation":[{"name":"Department of Health Data Science, Graduate School of Medicine, Hokkaido University, Sapporo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5073-0827","authenticated-orcid":false,"given":"Yoichi M","family":"Ito","sequence":"additional","affiliation":[{"name":"Data Science Center, Promotion Unit, Institute of Health Science Innovation for Medical Care, Hokkaido University Hospital, Sapporo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,3,14]]},"reference":[{"key":"bibr1-17407745241230287","unstructured":"Ministry of Economy Trade and Industry. 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A study to investigate if early atrial fibrillation (AF) diagnosis reduces risk of events like stroke in the real-world, https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04276441 (accessed 13 May 2023)."},{"key":"bibr57-17407745241230287","unstructured":"ClinicalTrials.gov. eHealth weight loss program in African American breast cancer survivors, https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02699983 (accessed 13 May 2023)."},{"key":"bibr58-17407745241230287","unstructured":"ClinicalTrials.gov. Weight management and health behavior intervention in lowering cancer risk for BRCA positive and lynch syndrome families, https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04125914 (accessed 13 May 2023)."},{"key":"bibr59-17407745241230287","unstructured":"ClinicalTrials.gov. Exercise intervention after cancer treatment for improving health in stage II-III breast cancer survivors (PACT), https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03523195 (accessed 13 May 2023)."},{"key":"bibr60-17407745241230287","unstructured":"ClinicalTrials.gov. The patterns of activity and cognition during treatment (PACT) study, https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04562987 (accessed 13 May 2023)."},{"key":"bibr61-17407745241230287","unstructured":"ClinicalTrials.gov. Patient activation through counseling, exercise, and mobilization (PACE-Mobil), https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03411200 (accessed 13 May 2023)."},{"key":"bibr62-17407745241230287","unstructured":"ClinicalTrials.gov. Accuracy of the Apple Watch series 4 for detection of heart rhythm: a pilot study, https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03798613 (accessed 13 May 2023)."},{"key":"bibr63-17407745241230287","unstructured":"ClinicalTrials.gov. Apple Watch heart failure study, https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04510779 (accessed 13 May 2023)."},{"key":"bibr64-17407745241230287","unstructured":"ClinicalTrials.gov. Heart watch study: a pragmatic randomized controlled trial, https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04468321 (accessed 13 May 2023)."},{"key":"bibr65-17407745241230287","unstructured":"ClinicalTrials.gov. A study to investigate if early atrial fibrillation (AF) diagnosis reduces risk of events like stroke in the real-world, https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04276441 (accessed 13 May 2023)."},{"key":"bibr66-17407745241230287","unstructured":"ClinicalTrials.gov. Identification of arrhythmias with one-time ECG, https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03753139 (accessed 13 May 2023)."},{"key":"bibr67-17407745241230287","unstructured":"ClinicalTrials.gov. Portable measurement methods combined with artificial intelligence in detection of atrial fibrillation (WB-AF), https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04917653 (accessed 13 May 2023)."},{"key":"bibr68-17407745241230287","unstructured":"ClinicalTrials.gov. Passive sensing technology for lapse measurement, https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03739151 (accessed 13 May 2023)."},{"key":"bibr69-17407745241230287","unstructured":"ClinicalTrials.gov. Lifestyle intervention program for former elite athletes (Champ4Life), https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03031951 (accessed 13 May 2023)."},{"key":"bibr70-17407745241230287","unstructured":"ClinicalTrials.gov. Evaluation of a family intervention program for the management of overweight or obese children (NEREU), https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01878994 (accessed 13 May 2023)."},{"key":"bibr71-17407745241230287","unstructured":"ClinicalTrials.gov. Supporting together exercise and play and improving nutrition (STEP IN), https:\/\/www.clinicaltrials.gov\/ct2\/show\/study\/NCT02724839 (accessed 13 May 2023)."},{"key":"bibr72-17407745241230287","unstructured":"ClinicalTrials.gov. Financial incentives for weight reduction study (FIReWoRk), https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03157713 (accessed 13 May 2023)."},{"key":"bibr73-17407745241230287","unstructured":"ClinicalTrials.gov. Sedentary behavior, cardiovascular function, and sleep (PACE), https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04137068 (accessed 13 May 2023)."},{"key":"bibr74-17407745241230287","unstructured":"ClinicalTrials.gov. Development and feasibility of an incentive scheme to promote walking\/cycling to school (RIGHT_TRACKS), https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02282631 (accessed 13 May 2023)."},{"key":"bibr75-17407745241230287","unstructured":"ClinicalTrials.gov. 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Mind-body interventions to mitigate effects of media use on sleep in early adolescents (Sleepazoid), https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04550507 (accessed 13 May 2023)."},{"key":"bibr80-17407745241230287","unstructured":"ClinicalTrials.gov. Efficacy of Tai Chi versus CBT-I in treating chronic insomnia in older adults, https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04384822 (accessed 13 May 2023)."},{"key":"bibr81-17407745241230287","unstructured":"ClinicalTrials.gov. M-Health administered sleep treatment to enhance recovery in bariatric populations (MASTER), https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04619771 (accessed 13 May 2023)."},{"key":"bibr82-17407745241230287","unstructured":"ClinicalTrials.gov. Reducing sleep disparities in minority children, https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01301989 (accessed 13 May 2023)."},{"key":"bibr83-17407745241230287","unstructured":"ClinicalTrials.gov. 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