Blood PressureNCT05554315
Speckle Plethysmography Pulse Transit Time as a Marker of Blood Pressure Changes
An observational study of Blood Pressure, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Blood Pressure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2023to 8 Aug 2025
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or female, aged 18 or greater in good general health as evidenced by medical history
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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
- Conditions
- Blood Pressure
- Keywords
- Optical Technique, Pulse Transit Time, Pearson Correlation Coefficient, Spg Waveform, Signal Quality, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Male or female, aged 18 or greater in good general health as evidenced by medical history |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of sPTT as a marker for blood pressure.
To examine the use of sPTT as a marker for blood pressure.
Measured: 1 year
Secondary outcomes (1)
use of sPTT in comparison to pPTT
To evaluate the use of sPTT in comparison to pPTT.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start19 Apr 2023
- Primary completion5 Aug 2025
- Study completion8 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Bruce J Tromberg, Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554315
- Sponsor's protocol ID
- 10000849
- Other IDs
- 000849-CH
- Status last verified
- 24 Feb 2026
- First submitted
- 22 Sep 2022
- Last updated
- 27 Feb 2026
- Results posted
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speckle Plethysmography Pulse Transit Time as a Marker of Blood Pressure Changes
- ClinicalTrials.gov ID
- NCT05554315
- Acronym / sponsor ID
- 10000849
- Conditions
- Blood Pressure
- Keywords
- Optical Technique, Pulse Transit Time, Pearson Correlation Coefficient, Spg Waveform, Signal Quality, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 8 Aug 2025 (actual)
- First posted
- 26 Sep 2022 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Male or female, aged 18 or greater in good general health as evidenced by medical history |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female, aged 18 or greater in good general health as evidenced by medical history
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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
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 secondary outcome
use of sPTT in comparison to pPTT
Time frame: 1 year
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 27 Feb 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- 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.
Bruce J Tromberg principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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 Blood Pressure, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 3 inclusion and 8 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 27 Feb 2026. 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?
Use of sPTT as a marker for blood pressure. (time frame: 1 year). 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 27 Feb 2026.