Clinical ink, a global life science technology company, announces the addition of five new connected devices covering sleep staging, home sleep apnea testing, and research-grade actigraphy to its validated eClinical platform that integrates eCOA and glucose monitoring.
Winston-Salem, NC – Clinical ink today announced it is extending its Digital Health Technology (DHT) portfolio into sleep and physical activity measurement. Five new 510(k)-cleared device integrations will bring sleep staging, home sleep apnea testing, and research-grade actigraphy into the Clinical ink platform, giving Sponsors a dynamic real-time view of symptoms and biomarkers across multiple therapeutic areas.
- Empatica’s FDA-cleared EmbracePlus and EmbraceMini wearables deliver a full suite of actigraphy and sleep measures, including physical activity, sleep onset latency (SOL), wake after sleep onset, total sleep time (TST), and others, with the additional benefit of pulse rate, pulse rate variability, respiratory rate, blood oxygen saturation (SpO2), skin temperature, electrodermalactivity, and ambient light from its modular wrist-worn devices.
- Ametris’ FDA-cleared ActiGraph LEAP®, a research-grade multi-sensor activity monitor, delivers a second full suite of actigraphy and sleep measures with additional gait, cardiac rhythm, andcough endpoints.
- Compumedics’ FDA-cleared Somfit® Pro delivers at-home sleep testing measurements, including TST, SOL, sleep efficiency and staging, head and body position and movement, arousal events, snoring, ambient light, and both apnea-hypopnea index (AHI) and peripheral AHI(pAHI).
- Finally, Clinical ink will be adding a FDA-cleared wrist-worn home sleep apnea test for diagnostic-grade measurement of pAHI.
“Sponsors require real-time integration of symptoms and diaries/eCOA with connected device data within a single platform and operational ecosystem. We have been a leading innovator in our industry with glucose and weight endpoints and are now progressing into sleep and movement,” said JonathanGoldman, MD, Chief Executive Officer. Dr. Goldman added: “This integrated approach, where DHTcan trigger diaries, is rapidly becoming a required approach for endpoint collection in multiple therapeutic areas beyond cardiometabolic disease, including CNS, oncology, and immunology.”
Each connected device is selected on a per-study basis. Additional features of the device integrations include alerts when compliance drops or an assessment is missed, dashboards for compliance, assessment, endpoint, and data quality review, and live device telemetry. Dedicated device logistics and study support teams stand behind every deployment.
Megan Petrylak, Chief Operating Officer, added: “Operational support is essential for the deployment of integrated DHT clinical trials. Our team focuses on the end-to-end ecosystem from design and procurement to feature standardization, site and participant training, and help desk support. Success in these trials requires a close partnership among our team, Sponsor, CRO, site and, most importantly, the participant. We look forward to bringing new therapies to patients and their families.”
About Clinical ink
Clinical ink is the global life science company that brings data, technology, and patient science together. Our deep therapeutic-area expertise, coupled with eCOA, EDC, connected devices and patient engagement tools (telehealth, eConsent, eRetention), drive the industry standard for precision data capture.
