Clincosm LogoSign in Get a demo

Central Apnoea Monitor Study

Sponsor
Sheffield Children's NHS Foundation Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT06093347
Collaborator
Sheffield Hallam University (Other)
15
Enrollment
1
Location
9.4
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

An initial small study on 15 children that are already being investigated for central sleep apnoea in the sleep unit at Sheffield Children's Hospital. The central apnoea monitor will be placed around the child's abdomen overnight alongside the sensors already being used for the clinical sleep study and the signals from the two systems will be compared to evaluate the accuracy of the new device.

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 Wearable Wireless Device for Monitoring Central Apnoeas in Infants and Children
    Actual Study Start Date :
    Sep 18, 2023
    Anticipated Primary Completion Date :
    Jun 30, 2024
    Anticipated Study Completion Date :
    Jun 30, 2024

    Outcome Measures

    Primary Outcome Measures

    1. The accuracy of the system in 15 patients, when compared with the gold standard measurement system [24 hours]

    2. The acceptability of the sensor to the child as viewed by the parent (and child) [End of study]

      As measured by researcher designed questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 5 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients who have been referred for a cardio-respiratory polygraphy sleep study.

    • Patients aged 1 month up to 5 years 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:
    NCT06093347
    Other Study ID Numbers:
    • SCH-2708
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Apnea
    Sleep Apnea, Central

    Study Results

    No Results Posted as of Oct 23, 2023