Withings Pulse Wave Velocity and Blood Pressure Study

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

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Translational Science Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Subjects will be expected to participate for a total of 16 weeks.

Collaborators and Investigators

• Sponsor: Scripps Translational Science Institute
• Collaborators: Withings
• Investigators: Principal Investigator: Brian D Modena, MD, Scripps Translational Science Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2017
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Neurologic Manifestations; Hypertension; Sleep Wake Disorders; Stress, Psychological
• Other Study ID Numbers: IRB-16-6856

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No