Continuous Monitoring Using a Wearable Device Detects Activity-Induced Heart Rate Changes After Administration of Amphetamine

Wearable Device Monitoring Detects Activity-Induced Heart Rate Changes After Amphetamine Administration

Continuous Monitoring Using a Wearable Device Detects Activity-Induced Heart Rate Changes After Administration of Amphetamine

As sponsors increasingly turn to wearable sensors and connected devices to capture continuous physiological data in clinical trials, one question remains central to any digital biomarker strategy: is the device actually fit-for-purpose for its intended context of use?

A peer-reviewed study published in Clinical and Translational Science, led by researchers now affiliated with Koneksa Health and Takeda Pharmaceuticals, evaluated two FDA 510(k)-cleared wearable devices deployed in a 10-day residential Phase I clinical trial: the Philips Actiwatch Spectrum Pro (actigraphy for mobility and sleep) and the VitalConnect HealthPatch MD (a biosensor patch for heart rate, respiratory rate, and skin temperature).

A peer-reviewed study published in Clinical and Translational Science, authored by researchers now affiliated with Koneksa Health and Takeda Pharmaceuticals, evaluated two FDA 510(k)-cleared wearable devices deployed in a Phase I clinical trial of a novel compound that included an amphetamine challenge. The Philips Actiwatch Spectrum Pro (Actiwatch) was used to assess mobility and sleep, while the Preventice BodyGuardian was used to continuously monitor heart rate (HR) and respiratory rate (RR) via single-lead ECG, alongside physical activity.

Key Findings from the Study

• Heart rate accuracy: Wearable device-derived HR data were highly consistent with in-clinic HR measurements, supporting the device’s ability to detect real physiological changes, including activity-induced HR increases following amphetamine administration.
• Respiratory rate limitations: RR measurements did not show strong agreement with in-clinic values; Bland-Altman analysis found 95% limits of agreement of −5.5 to 5.2 breaths/minute, corresponding to 71% of the mean RR, a wide enough margin to limit the parameter’s clinical utility in this context.
• Activity-linked pharmacodynamics: The study demonstrated that continuous wearable monitoring could capture the expected pharmacodynamic HR response to a stimulant challenge, illustrating a real-world use case for wearables beyond simple vital sign spot-checks.
• Device-specific conclusions: As with earlier Koneksa/Takeda wearable validation work, results reinforced that HR monitoring from a wearable ECG-based device can be clinically reliable, while RR derived from the same device requires further scrutiny before use as a trial endpoint.

The Takeaway for Sponsors and Clinical Operations Teams

This study reinforces a core principle in digital biomarker strategy: regulatory clearance is not the same as fit-for-purpose validation for a specific endpoint or trial design. Before deploying any wearable or connected sensor technology in a clinical trial, Phase I through Phase III, in-clinic or decentralized, sponsors need device-specific evidence that data quality, completeness, and correlation with established clinical measures meet the bar required for the intended use case.

This is precisely the kind of fit-for-purpose evaluation Koneksa Health builds into every digital measurement strategy: rigorous device validation, human factors assessment, and data quality review, so sponsors can move forward with confidence in their digital endpoints.

Reference: Izmailova ES, McLean IL, Bhatia G, et al. Evaluation of Wearable Digital Devices in a Phase I Clinical Trial. Clin Transl Sci. 2019;12(3):247-256. doi:10.1111/cts.12602. PMID: 30635980

The Takeaway for Sponsors and Clinical Operations Teams

This study adds to a growing body of evidence that wearable devices can reliably detect pharmacologically induced physiological changes, but that reliability is parameter-specific, not device-wide. Heart rate monitoring proved robust even during an active pharmacologic challenge, while respiratory rate again fell short of the agreement needed for regulatory-grade endpoints.

This is the kind of endpoint-by-endpoint validation Koneksa Health builds into every digital measurement strategy, so sponsors know exactly which wearable-derived parameters they can rely on, and where additional validation or alternative measures are needed.

Reference: Izmailova ES, McLean IL, Hather G, et al. Continuous Monitoring Using a Wearable Device Detects Activity-Induced Heart Rate Changes After Administration of Amphetamine. Clin Transl Sci. 2019;12(6):677-686. doi:10.1111/cts.12673. PMID: 31365190.