Reliability and ValidityNCT05636761
Heart Rate Variability Recording With Elite HRV Application and Polar V800
An observational study of Reliability and Validity, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The Elite HRV is a reliable HRV analysis tool and could be a valid option to replace the Polar V800. The objective of study is Comparing the HRV index recorded with the mobile app Elite HRV and with the multisport watch Polar V800. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Reliability and Validity
- What is being tested?
- Heart rate variability
- How many people
- 58 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Apr 2020to 15 Feb 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: To determine the sample size, a sample size calculation was performed, assuming the following parameters: alpha of 5%, beta of 20% (power = 80%) and difference between groups of 10% regarding the scores on the scale. With these data, 30 subjects were calculated in each study arm.
Who may be able to join
- Individuals over 18 years of age
- Apparently healthy
Who cannot join
- Diagnoses of previously installed heart disease
- Continuous medication use that can alter HRV
- Use of any substance that could influence the autonomic nervous system, such as caffeinated drinks and foods.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparation of Heart Rate Variability Recording With Elite HRV Application and Polar V800 for the Analysis in Healthy Adults
The Elite HRV is a reliable HRV analysis tool and could be a valid option to replace the Polar V800. The objective of study is Comparing the HRV index recorded with the mobile app Elite HRV and with the multisport watch Polar V800. Individuals will submit to two RR interval recordings with a Polar H7 strap that sent the data either to the Polar V800 heart rate monitor or to the Elite HRV app. The volunteers will supine position and breathing spontaneously, and the RR intervals will collect during 25 minutes. Subsequently, without warning the subject, the strap will connect to a nother device, and the second 25minute evaluation was made. The order in which the devices will use is randomized and the HRV indexes will generated via Kubios HRV.
Read the detailed description
Sample Characterization Before starting the evaluation, an anamnesis will apply, in order to know the individual characteristics of each candidate and verify if he eligible. In addition, anthropometric variables such as weight, height and Body Mass Index will perform to characterize the individuals.
Heart Rate Variability (HRV) Heart rate will recorded beat by beat using a heart rate meter (Polar H10, Polar Electro, Kempele, Finland) at a sampling rate of 5 kHz to assess cardiac autonomic modulation.
With the chest strap and the receiving and recording device (Elite HRV and Polar V800), the subjects will be positioned in the supine position and remained at rest with spontaneous breathing for 25 min. The laboratory temperature was controlled at 20°C, and data classification was performed in the morning or afternoon, always with a minimum fasting of 2 hours. Participants ask to avoid consuming coffee, chocolate or alcohol and taking medication the night before. Then, without notifying the subject, the strap will be connect to the other receiving device and a new 25-minute collection will perform.
For analysis of HRV data, the last 20 minutes of each collection will select. In the future, the first 1000 beat intervals were chosen and only series with more than 95% of sinus beats were included in the study, totaling 1000 consecutive RR intervals.
HRV analysis was performed using linear methods, analyzed in the time and frequency domains, according to the guidelines of the Task Force of the European Society of Cardiology and the North American Society of Stimulation and Electrophysiology.
STATISTICAL ANALYSIS To determine the difference between the device data, the one-sample t-test will be use. Pearson's correlation coefficient was chosen to evaluate the correlation and it was considered null, weak, moderate, strong, very strong or perfect, when, respectively, r=0; r=0 to 0.3; r=0.3 to 0.6; r=0.6 to 0.9; r=0.9 to 1; r=1.
Bland Altman Plots with limits of agreement of 95% were constructed for all indices in order to assess agreement and bias between the different forms of HRV capture. In addition, to analyze the presence of proportion bias, linear regression was used and in case of non-significance, the hypothesis of proportion bias was discarded.
We also used Multiple Analysis of Variance (MANOVA) for comparison between Groups (started with Elite HRV versus started with Polar) with Repeated Measures for comparison within Devices (Elite HRV versus Polar). ANOVA one-way with repeated measures for comparisons of Devices (without order comparison) was done to determine p value and effect size. Values of p <0.05 were considered significant. The statistical package used was the Statistical Package for Social Sciences (SPSS; IBM, Chicago, Illinois, USA), version 26.0.
- Conditions
- Reliability and Validity
- Being tested
- Heart rate variability
- Keywords
- Cardiovascular Risk Factors, Heart rate, Mobile Applications, Autonomic Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate variabilityDiagnostic test
Collection and Analysis of Heart Rate Variability
| Study group | Role | What they receive |
|---|---|---|
| group EliteHRV | the group (Elite) that started the assessment with the EliteHRV mobile application Receives: Diagnostic Test: Heart rate variability | |
| group Polar | the (Polar) group that started the evaluation with the Polar V800 watch Receives: Diagnostic Test: Heart rate variability |
What is being measured
The primary outcome is the main question the study is designed to answer.
similarity of indices of heart rate variability between two devices
assessment of heart rate variability indices from both devices
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start13 Apr 2020
- Primary completion15 Sep 2022
- Study completion15 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reliability and ValidityStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Talita Dias da Silva, University of Sao Paulo
- Investigators
- Talita D da Silva, Principal investigator, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636761
- Sponsor's protocol ID
- 29108019.8.0000.5505
- Status last verified
- Dec 2022
- First submitted
- 4 Nov 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparation of Heart Rate Variability Recording With Elite HRV Application and Polar V800 for the Analysis in Healthy Adults
- ClinicalTrials.gov ID
- NCT05636761
- Acronym / sponsor ID
- 29108019.8.0000.5505
- Conditions
- Reliability and Validity
- Keywords
- Cardiovascular Risk Factors, Heart rate, Mobile Applications, Autonomic Nervous System
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Feb 2023 (estimated)
- First posted
- 5 Dec 2022 (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 Elite HRV is a reliable HRV analysis tool and could be a valid option to replace the Polar V800. The objective of study is Comparing the HRV index recorded with the mobile app Elite HRV and with the multisport watch Polar V800. Individuals will submit to two RR interval recordings with a Polar H7 strap that sent the data either to the Polar V800 heart rate monitor or to the Elite HRV app. The volunteers will supine position and breathing spontaneously, and the RR intervals will collect during 25 minutes. Subsequently, without warning the subject, the strap will connect to a nother device, and the second 25minute evaluation was made. The order in which the devices will use is randomized and the HRV indexes will generated via Kubios HRV.
Detailed description
Sample Characterization Before starting the evaluation, an anamnesis will apply, in order to know the individual characteristics of each candidate and verify if he eligible. In addition, anthropometric variables such as weight, height and Body Mass Index will perform to characterize the individuals.
Heart Rate Variability (HRV) Heart rate will recorded beat by beat using a heart rate meter (Polar H10, Polar Electro, Kempele, Finland) at a sampling rate of 5 kHz to assess cardiac autonomic modulation.
With the chest strap and the receiving and recording device (Elite HRV and Polar V800), the subjects will be positioned in the supine position and remained at rest with spontaneous breathing for 25 min. The laboratory temperature was controlled at 20°C, and data classification was performed in the morning or afternoon, always with a minimum fasting of 2 hours. Participants ask to avoid consuming coffee, chocolate or alcohol and taking medication the night before. Then, without notifying the subject, the strap will be connect to the other receiving device and a new 25-minute collection will perform.
For analysis of HRV data, the last 20 minutes of each collection will select. In the future, the first 1000 beat intervals were chosen and only series with more than 95% of sinus beats were included in the study, totaling 1000 consecutive RR intervals.
HRV analysis was performed using linear methods, analyzed in the time and frequency domains, according to the guidelines of the Task Force of the European Society of Cardiology and the North American Society of Stimulation and Electrophysiology.
STATISTICAL ANALYSIS To determine the difference between the device data, the one-sample t-test will be use. Pearson's correlation coefficient was chosen to evaluate the correlation and it was considered null, weak, moderate, strong, very strong or perfect, when, respectively, r=0; r=0 to 0.3; r=0.3 to 0.6; r=0.6 to 0.9; r=0.9 to 1; r=1.
Bland Altman Plots with limits of agreement of 95% were constructed for all indices in order to assess agreement and bias between the different forms of HRV capture. In addition, to analyze the presence of proportion bias, linear regression was used and in case of non-significance, the hypothesis of proportion bias was discarded.
We also used Multiple Analysis of Variance (MANOVA) for comparison between Groups (started with Elite HRV versus started with Polar) with Repeated Measures for comparison within Devices (Elite HRV versus Polar). ANOVA one-way with repeated measures for comparisons of Devices (without order comparison) was done to determine p value and effect size. Values of p <0.05 were considered significant. The statistical package used was the Statistical Package for Social Sciences (SPSS; IBM, Chicago, Illinois, USA), version 26.0.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group EliteHRV | – | Diagnostic Test: Heart rate variabilitythe group (Elite) that started the assessment with the EliteHRV mobile application |
| group Polar | – | Diagnostic Test: Heart rate variabilitythe (Polar) group that started the evaluation with the Polar V800 watch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- To determine the sample size, a sample size calculation was performed, assuming the following parameters: alpha of 5%, beta of 20% (power = 80%) and difference between groups of 10% regarding the scores on the scale. With these data, 30 subjects were calculated in each study arm.
Key inclusion criteria (2 listed)
- Individuals over 18 years of age
- Apparently healthy
Key exclusion criteria (3 listed)
- Diagnoses of previously installed heart disease
- Continuous medication use that can alter HRV
- Use of any substance that could influence the autonomic nervous system, such as caffeinated drinks and foods.
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 |
|---|---|---|
| Heart rate variabilityCollection and Analysis of Heart Rate Variability | Diagnostic test | group EliteHRV, group Polar |
Primary outcome
similarity of indices of heart rate variability between two devices
Time frame: 1 day
assessment of heart rate variability indices from both devices
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
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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.
Talita D da Silva principal investigator
Researcher
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 Reliability and Validity, run by University of Sao Paulo at 1 site in Brazil.
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 3 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: status not confirmed, as of the sponsor's last update on 5 Dec 2022. 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 Brazil. 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?
Results are not available in the source record.
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?
similarity of indices of heart rate variability between two devices (time frame: 1 day). 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 5 Dec 2022.