Sleep Clinical
Trials
GENEActiv is a comfortable, lightweight and waterproof medical device that delivers continuous recording of high-resolution acceleration, environmental light, and temperature at any body location.
Its robust, neutral design can objectively monitor activity, sleep, and lifestyle, reliably for up to two months without the need for charging.
The GENEActiv system is a low burden for both patients and sites with proven high adherence in many studies. It produces unfiltered tri-axial acceleration data in SI units in an open data format.
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Activinsights’ GENEActiv device is your key to understanding the intricacies of behaviours, activity, sleep,
and lifestyle in real-world settings. Incorporate the GENEActive into your study toolkit and discover
a wealth of knowledge waiting to be uncovered.
Clinical Trials
A gold-standard solution for remotely measuring specific behaviours and activities of daily living. Raw data in open format deliver access to a wide range of validated measures.
Public Health Research
Sensor-level data is an essential resource in longitudinal studies, future-proofing output by allowing re-analysis with new algorithms at any stage.
Health Management and Clinical Trials
Data delivered directly to health professionals supports both research and management of chronic conditions (such as obesity and diabetes) and
rehabilitation.
Digital Measures Development
Use data from this verified measurement system to develop algorithms for digital measures that can be validated analytically and clinically against
appropriate criteria.
Behaviour Detection
Precise body movements, postures and micro-movements are reconstructed from the GENEActiv’s unfiltered raw acceleration data. These measures provide the basic for specific behaviour detection and qualification – such as scratching and tremor.
Evaluating Sleep and Circadian Rhythms
The GENEActiv captures unprocessed movement data, temperature, and light exposure, offering a comprehensive overview of sleep quality and duration. Use to assess disorders that impact rest activity rhythms, movement, and sleep – allowing a deeper understanding of these interactions.
ActivInsights Band Features
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GENEActiv falls under the classification of Class I Non-Sterile Medical Devices, under the Medical Device Directive
93/42/EEC. The GENEActiv has received FDA 510(k) exemption status.
In accordance with transitional provisions outlined in Regulation 2023/607, amending Regulations (EU) 2017/745
and (EU) 2017/746, we will be transitioning to compliance with the EU Medical Device Regulation (EU MDR).
Our 150+ digital measures include:
• Acceleration
• Physical Activity intensity
• Sedentary vs movement activity
• Posture changes
• Sleep / wake time
• Sleep event characterisation
