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The Doppler Feasibility Study

Feasibility Study to Evaluate a New Hands-free Doppler Heart Rate Monitor Normally Used to Measure the Fetal Heart Rate

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06093373
Enrollment
11
Registered
2023-10-23
Start date
2023-05-19
Completion date
2023-12-29
Last updated
2024-04-17

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

Conditions

Heart Rate Measurements

Brief summary

The study is an exploratory research study looking at the feasibility, acceptability and accuracy of a doppler device compared with the gold standard ECG. It will take place in the sleep unit at Sheffield Children's Hospital.

Interventions

None listed

Sponsors

Sheffield Hallam University
CollaboratorOTHER
Sheffield Children's NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
1 Months to 12 Months
Healthy volunteers
Yes

Inclusion criteria

* Patients who have been referred for a cardio-respiratory polygraphy sleep study. * Patients aged one month up to one year old.

Exclusion criteria

* Subjects whose parents/legal guardians/carers are not fluent in English, or who have special communication needs. * Child anticipated to become distressed with additional sensor. * Child too clinically unwell to take part (as decided by clinical staff).

Design outcomes

Primary

MeasureTime frameDescription
The accuracy of the system in 15 patients, when compared with the gold standard ECG1 hour
The acceptability of the sensor to the child as viewed by the parent1 hourAs measured by researcher designed questionnaire

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026