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OpenTrials
Completed

NCT Number: NCT06093373

The Doppler Feasibility Study

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.

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Key information

Conditions

Heart Rate Measurements

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Research Facility, Sheffield Children's Hospital

Sheffield, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. The accuracy of the system in 15 patients, when compared with the gold standard ECG

    Time frame: 1 hour

  2. The acceptability of the sensor to the child as viewed by the parent

    Time frame: 1 hour

    As measured by researcher designed questionnaire

Sponsors and collaborators

Lead sponsor

Sheffield Children's NHS Foundation Trust

Other

Collaborators

  • Sheffield Hallam University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 23, 2023
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.