NCT03747861

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

May 10, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2020

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

November 17, 2018

Last Update Submit

February 14, 2020

Conditions

HRV

Keywords

R-R intervalsHeart rateHRV

Outcome Measures

Primary Outcomes (1)

  • RR interval accuracy

    Accuracy of RR intervals estimating

    5-minute intervals every 30 minutes within 24 hours

Secondary Outcomes (5)

  • RR-intervals passing

    5-minute intervals every 30 minutes within 24 hours of use

  • HRV accuracy for time-domain measures

    5-minute intervals every 30 minutes within 24 hours

  • HRV accuracy for frequency-domain measures

    5-minute intervals every 30 minutes within 24 hours

  • HRV accuracy for time-domain measures

    24 hours intervals

  • HRV accuracy for frequency-domain measures

    24 hours intervals

Study Arms (1)

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.

Device: SenceBand

Interventions

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

Arm for HRV monitoring

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Doctor Sam Medical Network

Kyiv, Kyiv Oblast, Ukraine

Location

Study Officials

  • Yulia Kuznetsova-Arabuli, MD

    Dr. Sam LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2018

First Posted

November 20, 2018

Study Start

May 10, 2019

Primary Completion

January 24, 2020

Study Completion

January 24, 2020

Last Updated

February 18, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

UA(1)