New York CRO Lindus Health has teamed with US start-up Aktiia to evaluate user satisfaction with the latter’s optical blood pressure monitoring device in hypertensive individuals.
The clinical trial will examine user experience with the “cuffless” device, which is worn as a bracelet, measures blood pressure continuously using optical sensors, offering a more convenient alternative to traditional blood pressure cuffs.
As well as measuring user satisfaction, the trial will also observe the evolution of participants' blood pressure over the study period and correlate this data with sociodemographic, lifestyle, and health factors.
The aim is to enroll 7,500 people with known hypertension in the 12-week trial. Lindus will run all aspects of the study including protocol development, regulatory submissions, recruitment, monitoring and data management.
Lindus co-founder Michael Young, said "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."
This was echoed by Aktiia chief marketing officer, Jay Shah, who said “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."
The partnership is in keeping with the strategy that saw Lindus partner with Tasso, a provider of patient-centric blood collection solutions in June.
News of the collaboration comes just months after Lindus set up a dedicated contract research organization (CRO) for consumer health companies seeking clinical validation for their products.
The division will run studies of topical creams, prebiotics and probiotics, weight loss supplements, digital health interventions and over-the-counter medications.
Prior to that, in April, Lindus set up a CRO to provide services to the diagnostics industry.
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