The Doppler Feasibility Study

April 16, 2024 updated by: Sheffield Children's NHS Foundation Trust

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Sheffield, United Kingdom
        • Clinical Research Facility, Sheffield Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Children aged 1-12 months admitted to the Sleep Unit at Sheffield Children's Hospital

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Comparison

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The accuracy of the system in 15 patients, when compared with the gold standard ECG
Time Frame: 1 hour
1 hour
The acceptability of the sensor to the child as viewed by the parent
Time Frame: 1 hour
As measured by researcher designed questionnaire
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Children's NHS Foundation Trust

Collaborators

Sheffield Hallam University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2023

Primary Completion (Actual)

December 29, 2023

Study Completion (Actual)

December 29, 2023

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

October 16, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • SCH-2798

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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