Access to real world sleep assessment technology has undergone a dramatic expansion, revolutionising the landscape for sleep researchers. Collaborating closely with DATAcc, an FDA collaborative community hosted by DiMe, we’ve been at the forefront of standardising parameters of sleep measurement, streamlining the growing complexity that sleep researchers are facing.

Through collective insights from us and our industry colleagues, DATAcc has crafted a framework: Core Digital Measures of Sleep. This framework, alongside accompanying resources, aims to bolster the adoption of human-centric digital measures across the field.

Sleep plays a crucial role in various aspects of health and is linked to numerous conditions. Better sleep generally indicates better health, while disrupted sleep can indicate or cause chronic conditions. Measuring sleep disturbance facilitates the development of improved interventions and treatment options.

Challenging Contemporary Sleep Research Measurement Methods

The current landscape of sleep measurement in research and clinical care is being challenged by new methods. These digital approaches are less cumbersome and intrusive and give access to new insights in the natural sleep environment over long periods without compromising measurement accuracy.

Home-based sleep monitoring, exemplified by technologies like the GENEActiv wearable, heralds a transformative shift.  Wearable technology not only minimises patient burden but also allows participants to be evaluated in their environment, devoid of additional stressors. Moreover, they enable long-term evaluation and yield more comprehensive real world data, laying the groundwork for personalised interventions tailored to individual needs and fostering a more holistic understanding of sleep patterns.

At the heart of this evolution lies the establishment of a set of core digital measures, essential for ensuring the validity and consistency of data collection. In this endeavour, DATAcc, hosted by DiMe, are spearheading improved methodologies and facilitating the seamless remote collection of sleep data—all from the comfort and familiarity of a patient’s own home and bed.

Importance of Sleep Digital Measures

Activinsights has a diverse catalogue of over 150 digital measures at our disposal of which sleep digital measures are a significant part and can greatly enhance the depth of insight into any study. Digital measures of sleep form the foundational elements for potential clinical trial endpoints and significant digital health biomarkers

DiMe defines the Core Digital Measures of Sleep framework as standardised benchmarks with mature measurement solutions used across the industry to measure sleep, making it easier to compare data. This standardisation not only enhances efficiency but also amplifies the efficacy of digital clinical measures. With this optimised set of core digital clinical measures in sleep, health professionals can increase the availability of high-quality, standardised, and transparent sleep research in the naturalistic environment across therapeutic areas. This transformation holds the promise of advancing population health and addressing myriad diseases.

Employing the core set of sleep measures will not only bolster transparency in research methodologies but also support consistency across projects– reducing risk, accelerating projects, and helping communication with regulators.

Why are we supporting DiMe’s initiative?

We are backing DiMe’s DATAcc initiative for several compelling reasons that resonate deeply with our mission and expertise.

Drawing on our extensive experience in the sleep research domain, we recognise the paramount importance of standardisation. DiMe’s efforts align with our advocacy for industry-wide standardisation. This initiative represents a significant step towards establishing uniformity in sleep research methodologies—a cause we’ve championed for years.

One of the ways we have been aiming for standardisation is by designing our wearable, the GENEActiv, to output unfiltered, sensor-level data to enable seamless transitions from traditional actigraphy devices, to our modern technologies. The integration of historical data prevents data loss and prioritises the continuation of long-term studies. Our commitment to inter-device compatibility is inspired by our advocacy for establishing greater uniformity in all research methodologies including sleep.

Furthermore, DiMe’s initiative serves as a vital resource for researchers bringing real world sleep measures into their studies for the first time. It provides a foundational framework, offering a clear starting point for those navigating the complexities of sleep measurement. For seasoned researchers, these guidelines formalise and streamline practices that they may have informally adopted, potentially requiring only minor adjustments for alignment.

In essence, our support for DiMe’s initiative reflects our commitment to advancing the field of sleep research through standardisation, compatibility, and accessibility, ultimately fostering innovation and progress in understanding sleep and its implications for health and well-being.

Validation

We are proud to affirm that our technologies stand on a solid foundation, with over 1100 publications attesting to their widespread use, efficacy and reliability. Moreover, they have been deployed in over 200 clinical trials, further cementing their reputation as a trusted tool. The performance of our technologies continues to be assessed according to the best-in-class criteria established in the V3 framework.

Verification

The GENEActiv records unfiltered, sensor-level acceleration as well as light and temperature in SI units. The engineering validation is supported by internal infrastructure, processes and documentation managed under ISO13485 and ISO27001. The quality of the raw data collected underpins all our work and is recognised by external verification of measurement consistency (Esliger 2011, Ladha 2013), acceleration processing (van Hees 2013), sleep measurement (te Lindert 2013), sleep cycle determination (van Hees 2015) and assessment of activities of daily living (Rowlands 2014, Burton 2018).

Helpful Resources

Let us help guide you along your Sleep Digital Measure journey. Below are some useful resources:

• Our Digital Measures Catalogue
• GENEActiv; wearable used in 60 + sleep publications and clinical trials
• DATAcc by DiMe, Core Digital Measures of Sleep
• The V3 Framework – DATAcc by DiMe (dimesociety.org)

References

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