Speckle Plethysmography Pulse Transit Time as a Marker of Blood Pressure Changes

NCT05554315 | Completed

• 2 other identifiers: 10000849000849-CH
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Blood Pressure

Keywords

Optical Technique; Pulse Transit Time; Pearson Correlation Coefficient; Spg Waveform; Signal Quality; Natural History

Outcome Measures

Primary Outcomes (1)

• Use of sPTT as a marker for blood pressure.

  To examine the use of sPTT as a marker for blood pressure.

  1 year

Secondary Outcomes (1)

• use of sPTT in comparison to pPTT

  1 year

Study Arms (1)

1

Male or female, aged 18 or greater in good general health as evidenced by medical history

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or female, aged 18 or greater in good general health as evidenced by medical history

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Bruce J Tromberg

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 26, 2022
• Study Start: April 19, 2023
• Primary Completion: August 5, 2025
• Study Completion: August 8, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02-24

Locations

US (1)