HypertensionSenseC1NCT01622842
Bioimpedance and Arterial Distension
An observational study of Hypertension, run by Sense A/S at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2011to Dec 2011
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Equal number of females and males. Large variations of BMI Large variations of BP
Who may be able to join
- Age 18 - 80 years
- Mental ability to understand information to test subjects
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Bioimpedance of Human Tissue of the Upper Arm and Arterial Distension
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.
Read the detailed 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:
- 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.
- To verify that temporal variations synchronous with the heartbeat could be measured on all three groups.
Hypotheses:
- That experimentally in vivo determined electrical parameters for tissues would differ considerably from theoretical values and from values measured in vitro experiments.
- That the variations of the electrical parameters would exhibit little variation from person to person.
- Those simple experimental relations can be established for the electrical parameters by including a simple vascularization model.
- That it is possible to measure temporal variation of the impedance, which are synchronous with the heartbeat.
- That the measured values would facilitate the calculation of the differential blood pressure with accuracies better than 10 mmHg.
- Conditions
- Hypertension
- Keywords
- Impedance, Electrical, Tissue, Excitation frequency, arterial distension, distension wave form
- Medical subject headings
- Hypertension
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 |
|---|---|---|
| Bioimpedance | 8 females and 8 males BMI from 19 to 46 SBP from 119 to 182 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conductivities and permittivities in the spectral region from 1 KHz to 1 MHz.
Measured on 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. Muscles and vessels followed expectations based on litterature values for electrical properties. Subcutaneous fat had a higher conductivity and permittivity than predicted from literature values in all cases.
Measured: 1 hour
Secondary outcomes (1)
Temporal variations synchronous with the heartbeat
The temporal variations of impedances measured on 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. Temporal variations could be measured on all three groups.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Cross-sectional
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sense A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor
- Investigators
- Lars Lading, Prof., Study director, Sense A/STine W Hansen, MD, PhD, Principal investigator, Rigshospitalet (Copenhagen Univ. Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622842
- Sponsor's protocol ID
- H-1-2011-076
- Acronym
- SenseC1
- Status last verified
- Jun 2012
- First submitted
- 8 Jun 2012
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioimpedance of Human Tissue of the Upper Arm and Arterial Distension
- ClinicalTrials.gov ID
- NCT01622842
- Acronym / sponsor ID
- SenseC1 / H-1-2011-076
- Conditions
- Hypertension
- Keywords
- Impedance, Electrical, Tissue, Excitation frequency, arterial distension, distension wave form
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sense A/SIndustry (pharma, biotech, devices)
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Sep 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Jun 2012 (estimated)
- 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.
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.
Detailed 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:
- 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.
- To verify that temporal variations synchronous with the heartbeat could be measured on all three groups.
Hypotheses:
- That experimentally in vivo determined electrical parameters for tissues would differ considerably from theoretical values and from values measured in vitro experiments.
- That the variations of the electrical parameters would exhibit little variation from person to person.
- Those simple experimental relations can be established for the electrical parameters by including a simple vascularization model.
- That it is possible to measure temporal variation of the impedance, which are synchronous with the heartbeat.
- That the measured values would facilitate the calculation of the differential blood pressure with accuracies better than 10 mmHg.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bioimpedance | – | –8 females and 8 males BMI from 19 to 46 SBP from 119 to 182 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Equal number of females and males. Large variations of BMI Large variations of BP
Key inclusion criteria (2 listed)
- Age 18 - 80 years
- Mental ability to understand information to test subjects
Key exclusion criteria (7 listed)
- Serious illness
- Allergic reactions to ECG or EMG electrodes
- Mentally unstable or unable to perceive instructions
- Metal implants
- Claustrophobia
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
Conductivities and permittivities in the spectral region from 1 KHz to 1 MHz.
Time frame: 1 hour
Measured on 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. Muscles and vessels followed expectations based on litterature values for electrical properties. Subcutaneous fat had a higher conductivity and permittivity than predicted from literature values in all cases.
1 secondary outcome
Temporal variations synchronous with the heartbeat
Time frame: 1 hour
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 22 Jun 2012.
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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.
Lars Lading, Prof. study director
Sense A/S
Tine W Hansen, MD, PhD principal investigator
Rigshospitalet (Copenhagen Univ. Hospital)
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 Hypertension, run by Sense A/S at 1 site in Denmark.
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 2 inclusion and 7 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 22 Jun 2012. 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 Denmark. 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?
Conductivities and permittivities in the spectral region from 1 KHz to 1 MHz. (time frame: 1 hour). 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 22 Jun 2012; AzTrials last refreshed its copy on 1 Nov 2026.