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Withings Pulse Wave Velocity and Blood Pressure Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099954
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : March 1, 2018
Sponsor:
Collaborator:
Withings
Information provided by (Responsible Party):
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.

Condition or disease
Elevated Blood Pressure Hypertension Mental Stress Sleep Disorders

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.

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Withings Pulse Wave Velocity and Blood Pressure Study
Actual Study Start Date : January 19, 2017
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099954


Locations
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United States, California
Scripps Translational Science Institute
La Jolla, California, United States, 92037
Sponsors and Collaborators
Scripps Translational Science Institute
Withings
Investigators
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Principal Investigator: Brian D Modena, MD Scripps Translational Science Institute
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Responsible Party: Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT03099954    
Other Study ID Numbers: IRB-16-6856
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Wake Disorders
Hypertension
Stress, Psychological
Vascular Diseases
Cardiovascular Diseases
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Behavioral Symptoms