Oura Blood Pressure Profile Study

April 9, 2026 updated by: Ouraring Inc.

Oura Blood Pressure Profile Study: An Evaluation of the Oura Blood Pressure Profile Algorithm for Identifying Signs of Hypertension

The proposed study is designed as a prospective, single-arm, observational, non-significant risk device study to evaluate the performance of Oura's investigational Blood Pressure Profile algorithm in identifying signs of hypertension.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2000000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants will include users of the Oura Ring (Gen3 or newer) who are located in the United States and aged 22 years or older.

Description

Inclusion Criteria

  • Located in United States
  • Aged 22 years or older at time of eligibility screener
  • Oura Ring user (Oura Ring Gen3 or newer)
  • User of the English version of the Oura App
  • Smartphone (iOS or Android) user
  • Able to provide consent electronically

Exclusion Criteria

  • User of implanted cardiac electronic device(s)
  • Currently pregnant
  • Within 12 weeks postpartum

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity of the Oura Blood Pressure Profile classification for identifying participant-reported hypertension
Time Frame: From enrollment until up to 18 months
From enrollment until up to 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Specificity of the Oura Blood Pressure Profile classification versus participant-reported hypertension
Time Frame: From enrollment until up to 18 months
From enrollment until up to 18 months

Other Outcome Measures

Outcome Measure
Time Frame
Association between Oura Blood Pressure Profile classification and participant-measured systolic and diastolic blood pressure values
Time Frame: from enrollment until up to 18 months
from enrollment until up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ouraring Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTN-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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