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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000849-CH

Sponsoring Institute

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 99 Years

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women;
Children

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Blood Pressure

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Child Health and Human Development

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.

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Eligibility

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Bruce J. Tromberg
National Institute of Child Health and Human Development (NICHD)
BG 31 RM 1C14
31 CENTER DR
BETHESDA MD 20814
(301) 496-8859
bruce.tromberg@nih.gov

Brian Y. Hill
National Institute of Child Health and Human Development (NICHD)
BG 49 RM B1A27
49 CONVENT DR
BETHESDA MD 20814
(301) 827-0083
brian.hill@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT05554315

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