NCT07267871

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000,000

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Dec 2025May 2027

First Submitted

Initial submission to the registry

November 14, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

December 17, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

November 14, 2025

Last Update Submit

April 9, 2026

Conditions

High Blood PressureHypertension

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of the Oura Blood Pressure Profile classification for identifying participant-reported hypertension

    From enrollment until up to 18 months

Secondary Outcomes (1)

  • Specificity of the Oura Blood Pressure Profile classification versus participant-reported hypertension

    From enrollment until up to 18 months

Other Outcomes (1)

  • Association between Oura Blood Pressure Profile classification and participant-measured systolic and diastolic blood pressure values

    from enrollment until up to 18 months

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ouraring

San Francisco, California, 94108, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

December 5, 2025

Study Start

December 17, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

US(1)