Switzerland-based health tech company Aktiia has teamed up with Lindus Health to launch a clinical trial of the former’s optical blood pressure monitoring (OBPM) device in hypertensive individuals.
The 12-week clinical trial will evaluate the user experience with Aktiia’s non-invasive, cuffless OPBM device in 7,500 participants with known hypertension.
Lindus Health will provide end-to-end study management, including protocol development, regulatory submissions, recruitment, monitoring, and data management.
The company will use its in-house virtual site and digital marketing capabilities for patient recruitment through digital advertising, primary care screening and patient community outreach.
In addition, it will develop a dedicated study website with relevant trial information integrated with Lindus’ unique eClinical platform, Citrus, to simplify pre-screening and eConsent.
Lindus Health co-founder Michael Young said: “Lindus Health is incredibly humbled to be collaborating on the Aktiia trial, where we’ll have the ability to provide thousands of individuals with continuous visibility on their blood pressure continuously.
“Hypertension greatly burdens both patients and healthcare systems and there is an evident need for technologies that effectively help individuals manage chronic diseases while seamlessly integrating with their everyday lives.”
Aktiia’s OPBM device, worn as a bracelet, measures blood pressure continuously using optical sensors, offering a more convenient alternative to traditional blood pressure cuffs.
In addition to the user experience of the device, the study will evaluate the progress of participants’ blood pressure and correlate it with sociodemographic, lifestyle, and health factors.
Aktiia chief medical officer Jay Shah said: “Aktiia’s technology gives individuals greater autonomy to better manage their health.
“Our device and smartphone application allow patients and providers to understand their blood pressure patterns and changes in real-time, making it easier to pinpoint causes for fluctuations.
“We’re excited and proud to be working with Lindus Health to deliver blood pressure intelligence to patients with hypertension to help them better manage their condition.”