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Bioimpedance and Arterial Distension (SenseC1)

S

Sense A/S

Status

Completed

Conditions

Hypertension

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01622842
H-1-2011-076

Details and patient eligibility

About

The overall objectives were to investigate if characteristic dimensions for tissue and vessels determined from measured bioimpedance spectra would provide the same values as dimensions determined from MR images of the upper arm and verify that temporal variations of impedances could be converted to blood pressure.

Full description

It is emphasized that measurements of pulse wave velocity was not a part of this trial, which implies that only uncalibrated blood pressures could be measured. The specific objectives were:

  1. To determine conductivities and permittivities in the spectral region from 1 KHz to 1 MHz for persons with: (a) a normal distribution of fat and muscles, (b) exceptionally thick layers of subcutaneous fat, and (c) exceptionally thin layers of subcutaneous fat. Both sexes should be represented.
  2. To verify that temporal variations synchronous with the heartbeat could be measured on all three groups.

Hypotheses:

A. That experimentally in vivo determined electrical parameters for tissues would differ considerably from theoretical values and from values measured in vitro experiments.

B. That the variations of the electrical parameters would exhibit little variation from person to person.

C. Those simple experimental relations can be established for the electrical parameters by including a simple vascularization model.

D. That it is possible to measure temporal variation of the impedance, which are synchronous with the heartbeat.

E. That the measured values would facilitate the calculation of the differential blood pressure with accuracies better than 10 mmHg.

Enrollment

16 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age 18 - 80 years
  • Mental ability to understand information to test subjects

Exclusion criteria

  • Serious illness
  • Allergic reactions to ECG or EMG electrodes
  • Mentally unstable or unable to perceive instructions
  • Metal implants
  • Claustrophobia
  • Disqualified for MR scanning
  • Pregnant

Trial design

16 participants in 1 patient group

Bioimpedance
Description:
8 females and 8 males BMI from 19 to 46 SBP from 119 to 182

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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