The latest trend is wearable devices and they are now being used for medical applications. Several wearable medical devices are being assessed in clinical trials in a variety of medical conditions. Summarized in this article are some clinical trials testing wearable medical devices that are currently recruiting participants.
Currently underway at Scripps Translational Science Institute, San Diego, California, United States, is a pilot study of the ‘Quanttus’ for monitoring patients with congestive heart failure. The Quanttus is a wearable wrist watch-type device containing sensors that track and record heart rate, blood pressure, respiratory rate, temperature, and motion. The Quanttus will monitor vital signs in hospitalized participants who are subsequently discharged, with a 30 day monitoring period. Participants will be drawn from both men and women who have been hospitalized with a clinical diagnosis of acute decompensated heart failure who have home computer and internet access.
“Pilot Study of the QI Device for Monitoring of Patients With Congestive Heart Failure” https://www.clinicaltrials.gov/ct2/show/NCT02343523?term=wearable+devices&recr=Open&no_unk=Y&rank=1
A wearable therapeutic ultrasound device is being tested for relief of upper back (trapezius muscle) pain. The trial will assess use of the Sam® wearable ultrasound device for 4 weeks. The Sam® device emits a continuous ultrasound at a frequency of 3 MHz, and 0.132 watts/cm2 intensity. Participants will be able to initiate ultrasound therapy at the onset of muscle pain, and will record daily pain scores. On days when the patients report a pain score of 3 (1-10), the ultrasound device will be used for four hours. The primary outcome measure of the study will be a change in pain scores. Participants will be aged between 18 and 65 years old with acute trapezius muscle pain (as assessed by a healthcare provider), with a VAS pain score of greater than 3, between 3-4 times within the previous week. The study, conducted by ZetrOZ, Inc, Trumbull, Connecticut, United States, will enroll approximately 60 participants.
“Low Intensity Ultrasound Therapy for Upper Back Pain Relief” https://www.clinicaltrials.gov/ct2/show/NCT01917500?term=wearable+devices&recr=Open&no_unk=Y&rank=3
A study aiming to track sun exposure in participants who are at high risk for developing skin cancer will use a wearable UV dosimeter to measure solar radiation from sun exposure. The wearable UV sensor device, Sunbit, will be used to assess the feasibility of tracking UV exposure in daily life. The primary outcome measures of the study will be patient compliance, that is, the amount of days that the patient wears the device. Other outcome measures will assess the technical accuracy of the Sunbit device, and participants’ sun behaviours. The study will be conducted in the Department of Dermatology, University Hospital, Zürich. In all, 20 participants will be enrolled in the study and will each wear the device for 4 weeks. Participants will be recruited from a pool of patients with a high risk of melanoma and non-melanoma skin cancer, who are 18 years or older.
“Sunbit UV Measuring Device to Track Sun Behavior” https://www.clinicaltrials.gov/ct2/show/NCT02221843 term=wearable+devices&recr=Open&no_unk=Y&rank=8
Fitbit Flex is a wearable device that tracks physical activity, and is currently being tested at the University of British Columbia, in collaboration with the Simon Fraser University, Arthritis Research Centre of Canada, and Vancouver General Hospital, BC, Canada. In combination with an online or telephone physiotherapist coach, Fitbit Flex is being assessed for its effectiveness as a part of a physical activity counseling model to increase physical activity and decrease sedentary behavior in patients with knee osteoarthritis. The study will measure the total time spent in moderate to vigorous physical activity at 2, 4, and 6 months. Both knee injury and osteoarthritis outcome scores will also be calculated (knee pain, stiffness, daily activity, sport/recreation, and quality of life), at 2, 4, and 6 months. Participants will be eligible to take part in the study if they have been diagnosed with knee osteoarthritis, or if they are over 50 years old and have had 4 weeks of knee pain, aching, or discomfort in the past year.
“MONITOR-OA: Using Wearable Activity Trackers to Improve Physical Activity in Knee Osteoarthritis” https://www.clinicaltrials.gov/ct2/show/NCT02315664?term=wearable+devices&recr=Open&no_unk=Y&rank=21
Image courtesy of cooldesign at FreeDigitalPhotos.net
Written by Deborah Tallarigo, PhD