HRV Clinical Trial
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.
Verified date | February 2020 |
Source | Planexta, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 59 |
Est. completion date | January 24, 2020 |
Est. primary completion date | January 24, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Subject has given written informed consent; 2. Subject is male or female, aged 18-75; 3. Subject has understood and complied with the requirements of the study protocol and; 4. Subject is fluent in Ukrainian. Exclusion Criteria: 1. Subject has cardiac pacemakers; 2. Subject is a pregnant woman; 3. Subject has an allergy on polyurethane; 4. Subject refers to vulnerable groups of the population; 5. In investigator's opinion subject is not able physically or intellectually to fulfill the requirements of protocol. |
Country | Name | City | State |
---|---|---|---|
Ukraine | Doctor Sam Medical Network | Kyiv | Kyiv Region |
Lead Sponsor | Collaborator |
---|---|
Planexta, Inc | Pharmaxi LLC |
Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | RR interval accuracy | Accuracy of RR intervals estimating | 5-minute intervals every 30 minutes within 24 hours | |
Secondary | RR-intervals passing | Frequency of passing of determination of RR-intervals | 5-minute intervals every 30 minutes within 24 hours of use | |
Secondary | HRV accuracy for time-domain measures | HRV accuracy for time-domain measures (MeanNN, SDNN, RMSSD, pNN50) | 5-minute intervals every 30 minutes within 24 hours | |
Secondary | HRV accuracy for frequency-domain measures | HRV accuracy for time-domain measures (VLF, LF, HF, LF / HF) | 5-minute intervals every 30 minutes within 24 hours | |
Secondary | HRV accuracy for time-domain measures | HRV accuracy for time-domain measures (MeanNN, SDNN, RMSSD, pNN50) | 24 hours intervals | |
Secondary | HRV accuracy for frequency-domain measures | HRV accuracy for time-domain measures (VLF, LF, HF, LF / HF) | 24 hours intervals |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05659277 -
The Effects of Stress & Irregular Shift Hours on First Responders
|
||
Completed |
NCT06193291 -
Effect of Hot Water Immersion on Heart Rate Variability and Glucose
|
N/A | |
Completed |
NCT01185457 -
Effect of Interscalene Block on Heart Rate Variability (HRV)
|
N/A | |
Not yet recruiting |
NCT01755910 -
Effect of Thoracic Paravertebral Block on Heart Rate Variability (HRV)
|
N/A |