ŌURA establishes clinical trial to examine how Oura Ring data relate to outcomes from GLP-1 and MBS

ŌURA has announced the launch of SMART-BMI, its first clinical trial, in collaboration with UC San Diego Health, that will examine how sleep, heart rate, and activity data from Oura Ring relate to outcomes from GLP-1 treatment and bariatric surgery.

The multi-year study is the latest addition to Oura’s growing work in healthcare research, scientific validation, and outcomes measurement, led by the Office of Regulatory and Clinical Affairs (ORCA), which was built over the past year under Chief Medical Officer Dr. Ricky Bloomfield.

GLP-1 medications and bariatric surgery are among the most widely used approaches to treating obesity, but much of what happens between care visits, including how patients sleep, recover, and move, is rarely captured. SMART-BMI is designed to help close that gap.

The multi-year study will examine how physiological changes measured by Oura Ring, such as sleep, heart rate, and activity, are associated with obesity treatment outcomes. It will capture changes between care visits and examine associations with outcomes including weight loss, HbA1c, and treatment persistence.

Formalised over the past year under the leadership of Chief Medical Officer, Dr Ricky Bloomfield, the ORCA team brings together work Oura has been advancing for several years across clinical, regulatory, outcomes research, and informatics. By unifying these efforts, ORCA connects the core functions Oura needs to move continuous health data from measurement to evidence and ultimately, to responsible use in care.

ORCA’s work is organized around four connected disciplines:

• Scientific & Medical Evidence: Grounding every health experience Oura delivers in scientific and medical evidence and real-world clinical practice, including evaluating AI-powered experiences for clinical accuracy, safety, and trust.

• Regulatory & Quality: Navigating regulatory pathways across the U.S. Food and Drug Administration (FDA) and the European Union (EU), and other global markets while maintaining the quality management system (QMS) and processes that support our products, including its ISO 13485 certification for the design and development of medical device software.

• Outcomes research: Generating evidence that demonstrates how Oura impacts clinical outcomes, healthcare utilisation, and cost of care.

• Clinical ontology and informatics: Defining the clinical concepts, relationships, and data standards that make Oura measurements meaningful, interoperable, and useful across product, research, and healthcare systems.

"Since I started at Oura, my focus has been on formalizing the clinical rigor behind the trust people already place in their ring,” said Bloomfield. “As we take on a bigger role in healthcare with new use cases, partnerships, and levels of clinical evidence, that trust has to be earned at every step. We do that by ensuring the right measurement, the right validation, the right outcomes data at every layer. ORCA is how we hold ourselves to that standard, alongside the researchers and institutions we work with."

Outcomes research depends on accurate measurement. Oura Ring has been included in more than 200 peer-reviewed publications spanning sleep, cardiovascular health, women’s health, metabolic health, mental health, pregnancy, and other areas, including studies that evaluate its accuracy against established clinical and research reference standards:

• In an external validation study conducted by researchers at Brigham and Women’s Hospital comparing major consumer sleep trackers against PSG, Oura Ring was found to be the most accurate consumer sleep tracker tested for 4-stage sleep classification.

• An independent peer-reviewed study identified Oura as the most accurate tested activity tracker for heart rate and heart rate variability (HRV) measurements.

• A study published in JMIR showed that Oura Ring is an accurate women’s health product as well, with the Ovulation Detection algorithm outperforming the calendar tracking method and detecting 96.4% of ovulations with an average error of ±1.26 days.

“The path to a meaningful role in healthcare requires the right team, strong science, and a clear commitment to clinical validation and outcomes research,” said Tom Hale, chief executive officer at Oura. “We have brought together experts in clinical care, research, regulatory affairs, quality, and informatics to guide that work, alongside research partnerships that help us evaluate our technology against established standards and study its potential in real-world care settings.

Together, this foundation will help us earn trust and shape the responsible role continuous health data can play in care.”

Oura Ring is not a medical device and is not intended to diagnose, treat, cure, monitor, or prevent medical conditions or illnesses.

The study is registered at ClinicalTrials.gov, NCT07736729.