Withings Pulse Wave Velocity and Blood Pressure Study

Completed

• Conditions: Elevated Blood Pressure; Hypertension; Mental Stress; Sleep Disorders

• Registration Number: NCT03099954
• Lead Sponsor: Scripps Translational Science Institute

Brief Summary

Measure pulse wave velocity stability in relation to time of day, day of the week, physical activity, sleep quality, stress levels and blood pressure.

Detailed Description

The study population will be an estimated 300 healthy adult subjects from the United States. This population will be approximately 150 men and 150 women. In order to obtain a relatively diverse age range of users (with varying levels of arterial stiffness), we hope to enroll participants across three age ranges entered in the Withings application by the user: 18-40 years, 41-60 years, and \> 60 years. These spots will be filled by those that satisfy the inclusion/exclusion criteria on a first come, first served basis.

Study Timeline

• Study Start: 2017-01-19
• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2017-03-29
• Study First Posted: 2017-04-04
• Status Verified: 2017-06
• Primary Completion: 2017-08-01
• Study Completion: 2017-10-31
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• User of a (1) Withings blood pressure cuff (2) Withings activity tracker and (3) Withings Body Cardio scale
• User has measured their blood pressure at least once per week for the majority of weeks over the last three months.

Exclusion Criteria

• Aortic artery disease
• Peripheral vascular disease
• Atrial fibrillation
• Weight > 396 lbs.
• Pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure pulse wave velocity (PWV) stability in relation to time of day, day of the week, physical activity, sleep quality, stress levels and blood pressure.	Subjects will be expected to participate for a total of 16 weeks.	The study population will be an estimated 300 healthy adult subjects from the United States who own a Withings blood pressure cuff, Withings activity tracker, and Withings Body Cardio scale and have measured their blood pressure at least once per week for the majority of weeks over the last three months.

Trial Locations

Locations (1)

Scripps Translational Science Institute; 🇺🇸 La Jolla, California, United States