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NCT06093347 Clinical Trial

Central Apnoea Monitor Study

Sleep Apnea Clinical Trial

Official title:
Feasibility Study to Evaluate a New Wearable Wireless Device for Monitoring Central Apnoeas in Infants and Children

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06093347
Other study ID # SCH-2708
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 18, 2023
Est. completion date June 30, 2024

Study information
Verified date September 2023
Source Sheffield Children's NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 15
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 1 Month to 5 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Clinical Research Facility, Sheffield Children's Hospital Sheffield

Sponsors (2)
Lead Sponsor Collaborator
Sheffield Children's NHS Foundation Trust Sheffield Hallam University

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary The accuracy of the system in 15 patients, when compared with the gold standard measurement system 24 hours
Primary The acceptability of the sensor to the child as viewed by the parent (and child) As measured by researcher designed questionnaire End of study
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