Elevated Blood PressureNCT03099954
Withings Pulse Wave Velocity and Blood Pressure Study
An observational study of Elevated Blood Pressure and Hypertension, run by Scripps Translational Science Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elevated Blood Pressure, Hypertension, Mental Stress
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2017to 31 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Aortic artery disease
- Peripheral vascular disease
- Atrial fibrillation
- Weight > 396 lbs.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Translational Science Institute
La Jolla, California, 92037
About this 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.
Read the 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.
- Conditions
- Elevated Blood Pressure, Hypertension, Mental Stress, Sleep Disorders
- Medical subject headings
- Hypertension, Stress, Psychological, Sleep Wake Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Subjects will be expected to participate for a total of 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start19 Jan 2017
- Primary completion1 Aug 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Withings
- Responsible party
- Sponsor
- Investigators
- Brian D Modena, MD, Principal investigator, Scripps Translational Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099954
- Sponsor's protocol ID
- IRB-16-6856
- Status last verified
- Jun 2017
- First submitted
- 29 Mar 2017
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Withings Pulse Wave Velocity and Blood Pressure Study
- ClinicalTrials.gov ID
- NCT03099954
- Acronym / sponsor ID
- IRB-16-6856
- Conditions
- Elevated Blood Pressure, Hypertension, Mental Stress, Sleep Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Collaborators
- Withings
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- Aortic artery disease
- Peripheral vascular disease
- Atrial fibrillation
- Weight > 396 lbs.
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian D Modena, MD principal investigator
Scripps Translational Science Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elevated Blood Pressure and Hypertension, run by Scripps Translational Science Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.