A Comprehensive Optical Blood Pressure Assessment Tool to Identify Cases of Unscreened Hypertension Across an Active Population in the U.S.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-16

Study Completion Date

2025-08-31

Brief Summary

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To screen for and identify subjects with potential undiagnosed hypertension using an optical blood pressure monitoring device across an active workforce population in the US (Nucor employees).

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Detailed Description

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100 voluntary Nucor facility employees with no previous diagnosis of hypertension will be recruited and will receive an optical blood pressure monitoring device (Aktiia G1 Device) that is a miniature bracelet placed in the wrist and measure blood pressure continuously without inflating.

Each participant will wear the device continually during 28 days.

Conditions

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Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CATCH-US cohort

Non-hypertensive Nucor employees that accept to receive and wear continuously for 28 days an optical blood pressure monitoring device (Aktiia 24/7 device)

Optical Blood Pressure Monitoring Device (Aktiia G1)

Intervention Type DEVICE

Non-hypertensive Nucor employees that accept to wear an optical blood pressure monitoring device (Aktiia 24/7 device) to screen for and identify potential undiagnosed hypertension.

100 participants. Each participant will wear the device continuously for 28 days.

Interventions

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Optical Blood Pressure Monitoring Device (Aktiia G1)

Non-hypertensive Nucor employees that accept to wear an optical blood pressure monitoring device (Aktiia 24/7 device) to screen for and identify potential undiagnosed hypertension.

100 participants. Each participant will wear the device continuously for 28 days.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adult subjects aged 25 to 70 years old.
2. People who self-report that they do not have a diagnosis of hypertension.
3. People employed as a Nucor team member.
4. People who can read and speak English.
5. People who use either an iOS or Android smart phone.
6. Subjects who agree to follow study procedures.
7. Subjects who have signed the informed consent form.

Exclusion Criteria

1. Subjects with a known diagnosis of i. atrial fibrillation ii. congestive heart failure iii. heart valve disease iv. pheochromocytoma v. Raynaud's disease vi. arm lymphedema.
2. Subjects who take insulin.
3. Subjects who are on hemodialysis.
4. Women who are known to be pregnant.
5. Subjects whose arms shake uncontrollably or are paralyzed (cannot move).
6. Subjects who do not have two arms.
7. Subjects with upper arm circumference \< 22cm or \> 42cm.
8. Subjects with wrist circumference \> 23cm.

Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes