Implementation of a fully remote randomized clinical trial with cardiac monitoring

Background The coronavirus disease 2019 (COVID-19) pandemic has challenged researchers performing clinical trials to develop innovative approaches to mitigate infectious risk while maintaining rigorous safety monitoring. Methods In this report we describe the implementation of a novel exclusively remote randomized clinical trial (ClinicalTrials.gov NCT04354428) of hydroxychloroquine and azithromycin for the treatment of the SARS-CoV-2–mediated COVID-19 disease which included cardiovascular safety monitoring. All study activities were conducted remotely. Self-collected vital signs (temperature, respiratory rate, heart rate, and oxygen saturation) and electrocardiographic (ECG) measurements were transmitted digitally to investigators while mid-nasal swabs for SARS-CoV-2 testing were shipped. ECG collection relied on a consumer device (KardiaMobile 6L, AliveCor Inc.) that recorded and transmitted six-lead ECGs via participants’ internet-enabled devices to a central core laboratory, which measured and reported QTc intervals that were then used to monitor safety. Results Two hundred and thirty-one participants uploaded 3245 ECGs. Mean daily adherence to the ECG protocol was 85.2% and was similar to the survey and mid-nasal swab elements of the study. Adherence rates did not differ by age or sex assigned at birth and were high across all reported race and ethnicities. QTc prolongation meeting criteria for an adverse event occurred in 28 (12.1%) participants, with 2 occurring in the placebo group, 19 in the hydroxychloroquine group, and 7 in the hydroxychloroquine + azithromycin group. Conclusions Our report demonstrates that digital health technologies can be leveraged to conduct rigorous, safe, and entirely remote clinical trials.

Aptamer Based Point of Care Diagnostic for the Detection of Food Allergens

Aptamers, due to their small size, strong target affinity, and ease of chemical modification, are ideally suited for molecular detection technologies. Here, we describe successful use of aptamer technology in a consumer device for the detection of peanut antigen in food. The novel aptamer-based protein detection method is robust across a wide variety of food matrices and sensitive to peanut protein at concentrations as low as 12.5 ppm (37.5 µg peanut protein in the sample). Integration of the assay into a sensitive, stable, and consumer friendly portable device will empower users to easily and quickly assess the presence of peanut allergens in foods before eating. With most food reactions occurring outside the home, the type of technology described here has significant potential to improve lives for children and families.

1208 Sleep Stage Prediction And Sleep Disordered Breathing Detection Using Raw Actigraphy And Photoplethysmography From Wearable Consumer Device

Introduction Wearable, multisensory consumer devices that estimate sleep are prevalent and hold great potential. Most validated actigraphic prediction studies of sleep stages (SS) have only used low resolution (30 sec) data and the Cole-Kripke algorithm. Other algorithms are often proprietary and not accessible or validated. We present an automatic, data-driven deep learning algorithm that process raw actigraphy (ACC) and photoplethysmography (PPG) using a low-cost consumer device at high (25Hz) and low resolution to predict SS and to detect sleep disordered breathing (SDB) events. Methods Our automatic, data-driven algorithm is a deep neural network trained and evaluated to predict SS and SDB events on 236 recordings of ACC data from a wrist-worn accelerometer and PPG data from the overlapping PSG. The network was tested on raw ACC and PPG data, which was collected at 25 Hz using the HUAMI Arc2 wristband from 39 participants that underwent a nocturnal polysomnography (PSG). Results Overall accuracy (Acc), recall (Re), specificity (Sp), and kappa (κ) per subject on the test dataset the prediction of wake, NREM, REM was Acc=76.6%, Re=72.4%, Sp=78.0%, kappa=0.42. On average, we found a 7 % higher performance using the raw sensor data as input instead of processed, low resolution inputs. PPG was especially useful for REM detection. The network assigned 55.6% of patients to the correct SDB severity group when using an apnea-hypopnea index above 15. Conclusion Current results show that SS prediction is significantly improved when using the raw sensor data; it indicates that the system holds promise as a potential pervasive monitoring device for patients with chronic sleep disorders. In contrast the system did not show potential as a sleep apnea screening tool. Additional studies are ongoing to examine the effects of pathology such as sleep apnea and periodic leg movement on SS prediction. Support Technical University of Denmark; University of Copenhagen, Copenhagen Center for Health Technology, Klarman Family Foundation.

Validity of Fitbit Flex® consumer device on the sleep evaluation

This pilot study pretends to evaluate the accuracy of Fitbit Flex®, a consumer device for diary register, for the evaluation of sleep quality, compared to Actigraph GR3X, one of the most recommended actigraphs for sleep evaluation. To achieve this, sixty seven subjects without sleep disorders used simultaneously both monitors, Fitbit Flex® and Actigraph GT3X®, during one week nights. Even the significative differences between both monitors, de high correlation values and the ICC suggest that Fitbit Flex commercial device could be a useful instrument for the sleep quality evaluation, assuming that this result can not be considered interchangeable with Actigraph GR3X.

The future of otology

BackgroundThe field of otology is increasingly at the forefront of innovation in science and medicine. The inner ear, one of the most challenging systems to study, has been rendered much more open to inquiry by recent developments in research methodology. Promising advances of potential clinical impact have occurred in recent years in biological fields such as auditory genetics, ototoxic chemoprevention and organ of Corti regeneration. The interface of the ear with digital technology to remediate hearing loss, or as a consumer device within an intelligent ecosystem of connected devices, is receiving enormous creative energy. Automation and artificial intelligence can enhance otological medical and surgical practice. Otology is poised to enter a new renaissance period, in which many previously untreatable ear diseases will yield to newly introduced therapies.ObjectiveThis paper speculates on the direction otology will take in the coming decades.ConclusionMaking predictions about the future of otology is a risky endeavour. If the predictions are found wanting, it will likely be because of unforeseen revolutionary methods.

Validation of Consumer and Research-Grade Activity Monitors Against Polysomnography in Healthy Adults

Activity monitoring devices claiming to measure sleep have increased in popularity within research and consumer settings. However, validation studies on many of these devices are lacking. We examined twenty-nine healthy adults (Mage = 32.4, SDage = 11.6) overnight using three activity monitors (Actiwatch Spectrum Pro standard and sensitive settings, Fitbit One, Jawbone UP2) and polysomnography. We evaluated agreement between each device and polysomnography on total sleep time (TST) and sleep efficiency (SE). Clinically meaningful limits of agreement were set at ±30 minutes for TST and ±5% for SE. Each activity monitor overestimated TST and SE compared to polysomnography, and except for Actiwatch Spectrum Pro in sensitive setting, exceeded clinically meaningful agreement limits. Using Actiwatch Spectrum Pro sensitive as the gold standard, both consumer devices overestimated TST and SE, but their mean errors were generally not clinically meaningful (except Fitbit One’s error for SE). Actiwatch Spectrum Pro in its sensitive setting may be a valid substitute for polysomnography when measuring TST and SE. Choice of consumer device as an actigraphy replacement will depend on context. Jawbone UP2 shows closer agreement with Actiwatch Spectrum Pro, though Fitbit One demonstrates less variation in TST and SE estimations.

Minimum Requirements for a Successful Automotive Qualification With Focus on Packaging

Requirements off Automotive Tier1s and OEMs Klaus Pietrczak JCET Group, 46429 Landing Parkway, Fremont, CA 94538 [email protected] The automotive market size for power and discrete devices is growing at a rate of greater than 7 percent. Market drivers for this growth include ADAS, Infotainment and Powertrain. Getting an automotive device from initial specification to high volume manufacturing (HVM) can take four years compared to the typical three to six months it takes a consumer device. The requirements for automotive devices are much more complex. Increasing electronic content and zero failure over 15 years of lifetime are the major drivers for the ever increasing reliability requirements. The major document for any automotive device is the Production Part Approval Process (PPAP). This presentation will show the required content for the PPAP and which roles in an organization will contribute to it. There will also be a deeper dive into the three major automotive standards: IATF16949, AIAG and AEC. For each standard covered in-depth looking at the purpose, what the goal of the standard is, and a few examples for better understanding. Also covered will be the fact that even with all of these standards, not everything is covered. The device manufacturer having specific requirement on top of the standard requirements are more the standard rather than the exception. We will go into detail regarding who has to deliver what to which section and how they are all linked and interacting. The content on the standards will be completed by a look at the upcoming ISO26262-11, its intent, scope and expected influence on Semiconductor and OSATs. Finally, a look to some of the less defined but still important pieces of the puzzle. Examples of these include failure analysis procedure, product change/cancellation notification and data retention. While not an exhausting list, more often than not each is an important part of the business. An explanation of the purpose and typical requirements for these will be presented. This comprehensive review will give anyone targeting automotive business an overview of all that is required for automotive devices and the timeline to expect to get to HVM.