HRVNCT03747861
Measuring Accuracy of Wristband for Registration of ECG RR-Intervals for One Hand, SenceBand in Comparison to Holter
A study testing SenceBand in people with HRV, run by Planexta, Inc at 1 site in Ukraine.
Trial summary
The purpose of the study is to evaluate the measuring accuracy of the Wristband for registration of ECG RR intervals for one hand, SenceBand icompared to the Holter monitor (LabTech Ltd). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- HRV
- What is being tested?
- SenceBand
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUkraine
- Study dates
- 10 May 2019to 24 Jan 2020
- Phase
- Interventional
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has given written informed consent;
- Subject is male or female, aged 18-75;
- Subject has understood and complied with the requirements of the study protocol and;
- Subject is fluent in Ukrainian.
Who cannot join
- Subject has cardiac pacemakers;
- Subject is a pregnant woman;
- Subject has an allergy on polyurethane;
- Subject refers to vulnerable groups of the population;
- In investigator's opinion subject is not able physically or intellectually to fulfill the requirements of protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Clinical Study of Measuring Accuracy of RR- Intervals and Determining the Heart Rate Variability With a Wristband for Registration of ECG RR Intervals for One Hand, SenceBand Compared to the Holter Monitor.
The purpose of the study is to evaluate the measuring accuracy of the Wristband for registration of ECG RR intervals for one hand, SenceBand icompared to the Holter monitor (LabTech Ltd).
Read the detailed description
Non-randomized, prospective, open clinical trial . The main purpose is to evaluate the measuring accuracy of the Wristband for registration of ECG RR intervals for one hand, SenceBand in real-world condition during 24-hours of routine duties in comparison to a predicate device (Holter monitor). For monitoring HRV each subject will put heart rate monitor SenceBand in the randomly assigned wrist and Holter monitor electrodes will be placed in standard configurations places. Data will be collected during routine duties. SenceBand will collect data from 5-minutes intervals each 30 minutes, Holter will collect data continuously over 24 hours.
- Conditions
- HRV
- Being tested
- SenceBand
- Keywords
- R-R intervals, Heart rate, HRV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SenceBandDevice
Wristband for registration of ECG RR intervals for one hand, SenceBand will collect data from 5-minutes intervals each 30 minute within 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Arm for HRV monitoring | Other | For monitoring HRV each subject will put Wristband for registration of ECG RR intervals for one hand, SenceBand in the left wrist and Holter monitor electrodes will be placed in standard configurations places. Receives: Device: SenceBand |
What is being measured
The primary outcome is the main question the study is designed to answer.
RR interval accuracy
Accuracy of RR intervals estimating
Measured: 5-minute intervals every 30 minutes within 24 hours
Secondary outcomes (5)
RR-intervals passing
Frequency of passing of determination of RR-intervals
Measured: 5-minute intervals every 30 minutes within 24 hours of use
HRV accuracy for time-domain measures
HRV accuracy for time-domain measures (MeanNN, SDNN, RMSSD, pNN50)
Measured: 5-minute intervals every 30 minutes within 24 hours
HRV accuracy for frequency-domain measures
HRV accuracy for time-domain measures (VLF, LF, HF, LF / HF)
Measured: 5-minute intervals every 30 minutes within 24 hours
HRV accuracy for time-domain measures
HRV accuracy for time-domain measures (MeanNN, SDNN, RMSSD, pNN50)
Measured: 24 hours intervals
HRV accuracy for frequency-domain measures
HRV accuracy for time-domain measures (VLF, LF, HF, LF / HF)
Measured: 24 hours intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start10 May 2019
- Primary completion24 Jan 2020
- Study completion24 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HRVStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Planexta, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmaxi LLC
- Responsible party
- Sponsor
- Investigators
- Yulia Kuznetsova-Arabuli, MD, Principal investigator, Dr. Sam LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747861
- Sponsor's protocol ID
- SenceBand-001
- Status last verified
- Feb 2020
- First submitted
- 17 Nov 2018
- Last updated
- 18 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Clinical Study of Measuring Accuracy of RR- Intervals and Determining the Heart Rate Variability With a Wristband for Registration of ECG RR Intervals for One Hand, SenceBand Compared to the Holter Monitor.
- ClinicalTrials.gov ID
- NCT03747861
- Acronym / sponsor ID
- SenceBand-001
- Conditions
- HRV
- Keywords
- R-R intervals, Heart rate, HRV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Planexta, IncIndustry (pharma, biotech, devices)
- Collaborators
- Pharmaxi LLC
- Study start
- 10 May 2019 (actual)
- Primary completion
- 24 Jan 2020 (actual)
- Study completion
- 24 Jan 2020 (actual)
- First posted
- 20 Nov 2018 (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.
The purpose of the study is to evaluate the measuring accuracy of the Wristband for registration of ECG RR intervals for one hand, SenceBand icompared to the Holter monitor (LabTech Ltd).
Detailed description
Non-randomized, prospective, open clinical trial . The main purpose is to evaluate the measuring accuracy of the Wristband for registration of ECG RR intervals for one hand, SenceBand in real-world condition during 24-hours of routine duties in comparison to a predicate device (Holter monitor). For monitoring HRV each subject will put heart rate monitor SenceBand in the randomly assigned wrist and Holter monitor electrodes will be placed in standard configurations places. Data will be collected during routine duties. SenceBand will collect data from 5-minutes intervals each 30 minutes, Holter will collect data continuously over 24 hours.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm for HRV monitoring | Other | Device: SenceBandFor monitoring HRV each subject will put Wristband for registration of ECG RR intervals for one hand, SenceBand in the left wrist and Holter monitor electrodes will be placed in standard configurations places. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject has given written informed consent;
- Subject is male or female, aged 18-75;
- Subject has understood and complied with the requirements of the study protocol and;
- Subject is fluent in Ukrainian.
Key exclusion criteria (5 listed)
- Subject has cardiac pacemakers;
- Subject is a pregnant woman;
- Subject has an allergy on polyurethane;
- Subject refers to vulnerable groups of the population;
- In investigator's opinion subject is not able physically or intellectually to fulfill the requirements of protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SenceBandWristband for registration of ECG RR intervals for one hand, SenceBand will collect data from 5-minutes intervals each 30 minute within 24 hours | Device | Arm for HRV monitoring |
Primary outcome
RR interval accuracy
Time frame: 5-minute intervals every 30 minutes within 24 hours
Accuracy of RR intervals estimating
5 secondary outcomes
RR-intervals passing
Time frame: 5-minute intervals every 30 minutes within 24 hours of use
HRV accuracy for time-domain measures
Time frame: 5-minute intervals every 30 minutes within 24 hours
HRV accuracy for frequency-domain measures
Time frame: 5-minute intervals every 30 minutes within 24 hours
HRV accuracy for time-domain measures
Time frame: 24 hours intervals
HRV accuracy for frequency-domain measures
Time frame: 24 hours intervals
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 18 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Yulia Kuznetsova-Arabuli, MD principal investigator
Dr. Sam LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SenceBand in people with HRV, run by Planexta, Inc at 1 site in Ukraine.
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 4 inclusion and 5 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 18 Feb 2020. 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 Ukraine. 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?
RR interval accuracy (time frame: 5-minute intervals every 30 minutes within 24 hours). 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 18 Feb 2020.