Oura Blood Pressure Profile Study | NCT07267871

Studies
Oura Blood Pressure Profile Study

NCT07267871

Sponsor

Ouraring Inc.

Status

Recruiting

Last Update Posted

Apr 13, 2026Actual

Enrollment

2,000,000Estimated

Phase

Not provided

Conditions

Hypertension
High Blood Pressure

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 17, 2025Actual

Primary Completion Date

May 2027Estimated

Completion Date

May 2027Estimated

First Submitted Date

Nov 14, 2025

First Submission Date that Met QC Criteria

Nov 25, 2025

First Posted Date

Dec 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2026

Last Update Posted Date

Apr 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000,000Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ouraring	Recruiting	San Francisco	California	94108	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided