Skip to content

Validation of a device to monitor heart rhythm

Evaluation of Dozeeâ??s Electrocardiogram algorithm for the detection of abnormal heart rhythms and study of their effect on Ballistocardiography signals

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/02/050155
Enrollment
500
Registered
2023-02-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I489- Unspecified atrial fibrillation and atrial flutter

Interventions

None listed

Sponsors

Turtle Shell Technologies Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients above 18 years of age either in OPD or admitted in hospital Patients referred by PI for either standard ECG monitoring or continuous ECG monitoring using holter device or ECG patch Weight between 40kg to 120 kgs They are able and willing to provide written informed consent

Exclusion criteria

Exclusion criteria: Weight below 40 kgs and above 120 kgs Currently pregnant Have any condition that could interfere with the subjects ability to tolerate Holter monitor or the ECG patch Exhibit injuries, deformities, other abnormalities or skin condition that, in the opinion of the investigator, may prevent proper ECG patch and Holter or ECG machine application and functioning Level of agitation or non-compliance too high to enroll in opinion of PI Needs the use of equipments whose operation can interfere with Dozeeâ??s signal A significant medical condition in the judgment of the investigator, which may compromise the study testing procedures

Design outcomes

Primary

MeasureTime frame
Dozees ECG data will be analyzed using proprietary algorithms to determine the sensitivity and accuracy of Dozee in matching normal and abnormal rhythms obtained from standard ECG machine or Holter monitor or ECG patch. In addition, proprietary algorithms will be used to characterize the BCG patterns during abnormal rhythm instancesTimepoint: At baseline at the time of patient enrollment for the study

Secondary

MeasureTime frame
The secondary gold of this study is to evaluate the mechanical microvibration patterns during abnormal rhythm instances. Other secondary objective is to evaluate the PR interval QT interval and QRS intervals computed by the Dozee algorithms and that computed from the ECG obtained from the comparator holter or patch or standard ECGTimepoint: At baseline at the time of patient enrollment for the study

Countries

India

Contacts

Public ContactPooja Kadambi

Turtle Shell Technologies Pvt Ltd

pooja@dozee.io9611197910

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026