Wearable Clinical Trials
AstraOne validates wearables, biosensors, and consumer devices in regulatory-grade clinical studies — sleep trackers, cardiovascular monitors, activity sensors, and connected health platforms.
What we deliver
Wearable clinical validation
Accuracy, agreement, and usability studies vs. reference standards (PSG, ECG, spirometry, and more).
Biosensor clinical trials
Optical, electrical, and inertial sensor validation across sleep, cardiovascular, and metabolic endpoints.
Sleep tracker validation
Consumer and prescription sleep tracker validation vs. gold-standard PSG.
Digital biomarker validation
V3 framework-aligned verification, analytical validation, and clinical validation of digital measures.
Remote patient monitoring studies
RPM protocol design, device logistics, and longitudinal data capture at scale.
Connected health device trials
Bluetooth/LTE/BLE device studies with hub, gateway, and cloud pipeline validation.
Built for regulatory-grade evidence
- Validated wearable reference libraries (PSG, ECG, spirometry)
- Digital endpoint validation aligned with FDA and DiMe frameworks
- Device logistics, provisioning, and reverse logistics at scale
- Data pipeline validation from sensor to sponsor deliverable
Frequently asked questions
What is wearable clinical validation?
Wearable clinical validation is the process of demonstrating that a wearable device or its derived digital biomarkers measure what they claim, accurately, in the intended population, using pre-specified reference standards and statistical acceptance criteria.
Can you validate consumer wearables?
Yes. AstraOne runs consumer wearable and sleep tracker validation studies benchmarked against gold-standard reference devices such as PSG and clinical-grade ECG.
Ready to scope your study?
Talk to our clinical operations team about protocol design, recruitment, and execution.