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The Doppler Feasibility Study

Sponsor
Sheffield Children's NHS Foundation Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT06093373
Collaborator
Sheffield Hallam University (Other)
15
Enrollment
1
Location
7.4
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    15 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Feasibility Study to Evaluate a New Hands-free Doppler Heart Rate Monitor Normally Used to Measure the Fetal Heart Rate
    Actual Study Start Date :
    May 19, 2023
    Anticipated Primary Completion Date :
    Dec 29, 2023
    Anticipated Study Completion Date :
    Dec 29, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Comparison

    Outcome Measures

    Primary Outcome Measures

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

    2. The acceptability of the sensor to the child as viewed by the parent [1 hour]

      As measured by researcher designed questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 12 Months
    Sexes Eligible for Study:
    All
    Accepts 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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Research Facility, Sheffield Children's Hospital Sheffield United Kingdom

    Sponsors and Collaborators

    • Sheffield Children's NHS Foundation Trust
    • Sheffield Hallam University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sheffield Children's NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT06093373
    Other Study ID Numbers:
    • SCH-2798
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 23, 2023