About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
User of implanted cardiac electronic device(s)
Currently pregnant
Within 12 weeks postpartum
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Sensitivity of the Oura Blood Pressure Profile classification for identifying participant-reported hypertension
Secondary outcomes
Specificity of the Oura Blood Pressure Profile classification versus participant-reported hypertension
Other outcomes
Association between Oura Blood Pressure Profile classification and participant-measured systolic and diastolic blood pressure values
Sponsors and contacts
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