- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06093347
Central Apnoea Monitor Study
October 16, 2023 updated by: Sheffield Children's NHS Foundation Trust
Feasibility Study to Evaluate a New Wearable Wireless Device for Monitoring Central Apnoeas in Infants and Children
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
15
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
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-
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Sheffield, United Kingdom
- Recruiting
- Clinical Research Facility, Sheffield Children's Hospital
-
Contact:
- Heather Elphick
- Phone Number: 0114 2717000
- Email: h.elphick@nhs.net
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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
No
Sampling Method
Non-Probability Sample
Study Population
Children admitted to the Sleep Unit at Sheffield Children's Hospital with suspected sleep apnoea
Description
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).
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
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 measurement system
Time Frame: 24 hours
|
24 hours
|
|
The acceptability of the sensor to the child as viewed by the parent (and child)
Time Frame: End of study
|
As measured by researcher designed questionnaire
|
End of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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)
September 18, 2023
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
June 30, 2024
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)
October 23, 2023
Last Update Submitted That Met QC Criteria
October 16, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCH-2708
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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