Contribute Try STAT+ Today

In the last decade, the accessibility and use of actigraphy and physical activity tracking devices has dramatically increased in clinical research. From 2009 to 2019, there was a nearly 130 percent increase in registered active or recruiting Phase I–IV clinical trials that included actigraphy endpoints. Actigraphy measures and devices now offer researchers and sponsors the opportunity to address the shift toward patient-centric drug development, digital technologies, and remote measurement.

The field of actigraphy

A non-invasive method of collecting accelerometer data, actigraphy is leveraged in clinical trials requiring sleep and activity measures. Depending on a study’s objectives, data is typically gathered over a period of one to two weeks through a three-axis accelerometer, which may come in the form of a device worn on the wrist, waist, or ankle. With validated algorithms, trial teams can utilize devices’ dense raw and epoch data to produce valuable derived measures, including step count, activity intensity, and nighttime awakenings. This is where the field of actigraphy has shown tremendous growth — endless algorithm options available for unique study designs and age groups, diseases, and other measures of interest.

Significant study benefits

The field of actigraphy is beginning to embrace wearable technology to not only produce sensitive measures but also work around obstacles such as subjective patient reported outcomes and remote data collection that plague drug development research in multiple therapeutic areas. Actigraphy measures can benefit studies as primary or secondary efficacy endpoints, direct measures, supporting corollary measures, screening measures, or extensions of clinic-based assessments like the UPDRS and six-minute walk test. The introduction of digital devices means actigraphy has the potential to accelerate drug development timelines, enhance treatment efficacy, and help teams better manage project budgets.

Actigraphy devices, often with water-resistance properties for use during all activities of daily life, help studies gather dense data from patients in natural settings both remotely and continuously. Sensors in non-invasive wearable devices offer an objective alternative to patient reported outcomes like pain that are traditionally subjective. This alone can simplify study designs, improve patient experiences, and allow researchers to obtain data they may not have collected otherwise. In terms of patient satisfaction, actigraphy devices are more likely to produce ideal experiences and outcomes when they come equipped with a longer battery life, remain easy for patients to use, and integrate into everyday routines with little effort. Consumer grade devices finding success in clinical trials also give patients more autonomy in their healthcare journey and some control over appearances that would indicate study participation to the outside world.

Expanding opportunities

Deploying actigraphy in clinical trials necessitates careful planning: considering study objectives and patient populations, configuring devices and algorithms, navigating required measures, educating and supporting patients, and effectively collecting data. But the industry and the regulatory agencies that govern it are anticipating expansion in the variety of applications that actigraphy endpoints can serve, especially during a time when in-clinic observations are limited and healthcare consumers are expressing interest in receiving convenient in-home care. As sponsors and vendors look for opportunities to incorporate physical activity tracking and actigraphy wearables, available tools and strategies will continue to improve the accuracy and efficiency of the health data bringing new treatments to patients who need them most.

Learn more about Koneksa’s digital biomarker platform, including actigraphy tools for clinical trials, at koneksahealth.com.