Speckle Plethysmography Pulse Transit Time as a Marker of Blood Pressure Changes
Background:
Blood pressure is one of the key markers of cardiovascular health. High blood pressure, also called hypertension, can increase the risk of heart disease or stroke. Monitoring a person s blood pressure continuously over a 24-hour period at home is the best way to diagnose hypertension, but the equipment currently used to do it is cumbersome. This natural history study will test a new technique for monitoring blood pressure continuously over time.
Objective:
To test a new technique (speckle plethysmography) for measuring blood pressure in healthy adults.
Eligibility:
Healthy people aged 18 years and older.
Design:
Participants will come to the clinic a minimum of 2 times.
The screening visit will last up to 2 hours. Participants will have a physical exam. Their vital signs will be taken.
The clinical visit will last up to 1 hour. Participants will recline in a chair. Sensors to measure the activity of the heart will be placed on their chest. Different sensors will be placed on two fingers and one big toe. A device to measure blood pressure will be placed on one arm.
While wearing the sensors, participants will undergo 3 tests:
They will be asked to breathe slowly for 2 minutes.
They will be asked to solve a math problem.
They will immerse one hand or foot into an ice bath for up to 2 minutes.
Each test will be followed by a 5-minute recovery period.
Participants may elect to return for up to 3 more visits during the following week.
Study Overview
Status
Conditions
Detailed Description
Study Description:
This pilot study will investigate the use of a recently introduced optical technique, speckle plethysmography (SPG), as an alternative to photoplethysmography (PPG) for cuff-free blood pressure (BP) estimation using pulse transit time (PTT). Because of the increased signal quality of SPG in comparison to PPG, we hypothesize that pulse transit times calculated from ECG-SPG (sPTT) will have a better correlation to blood pressure than ECG-PPG (pPTT).
Objectives:
Primary Objective:
To examine the use of sPTT as a marker for blood pressure.
Secondary Objective:
To evaluate the use of sPTT in comparison to pPTT.
Exploratory Objectives:
- To explore if the SPG waveform by itself can be used as a marker for blood pressure.
- To evaluate signal quality of SPG in comparison to PPG across various skin tones.
Endpoints:
Primary Endpoints:
Pearson correlation coefficient between sPTT and BP.
Secondary Endpoints:
Pearson correlation coefficient between pPTT and BP.
Exploratory Endpoints:
- Pearson correlation coefficient between BP and signal markers to be determined.
- PPG Signal-to-noise ratio (SNR), SPG SNR
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Male or female, aged 18 or greater.
- In good general health as evidenced by medical history and physical.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Any active cardiovascular or pulmonary disorders or use of vasoactive medications.
- History of aneurysm or stroke.
- Pregnant by history.
- History of fainting or seizures.
- An open cut, sore, or bone fracture on or near the hands or feet.
- Known retinopathy, intraocular lens implantation, or glaucoma.
- Any other condition that in the opinion of the investigator would place the participant at unacceptable risk.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
1
Male or female, aged 18 or greater in good general health as evidenced by medical history
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Use of sPTT as a marker for blood pressure.
Time Frame: 1 year
|
To examine the use of sPTT as a marker for blood pressure.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
use of sPTT in comparison to pPTT
Time Frame: 1 year
|
To evaluate the use of sPTT in comparison to pPTT.
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Bruce J Tromberg, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 10000849
- 000849-CH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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