Withings Pulse Wave Velocity and Blood Pressure Study

Hypertension Clinical Trial

Official title:

Withings Pulse Wave Velocity and Blood Pressure Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099954
• Other study ID #: IRB-16-6856
• Status: Completed
• Phase: N/A
• First received: March 29, 2017
• Last updated: February 27, 2018
• Start date: January 19, 2017
• Est. completion date: October 31, 2017

Study information

• Verified date: June 2017
• Source: Scripps Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 31, 2017
• Est. primary completion date: August 1, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elevated Blood Pressure
• Hypertension
• Mental Stress
• Parasomnias
• Sleep Disorders
• Sleep Wake Disorders
• Stress, Psychological

Locations

Country	Name	City	State
United States	Scripps Translational Science Institute	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
Scripps Translational Science Institute	Withings/Nokia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.