WithdrawnNot Applicable

Central Apnoea Monitor Study

Stopped: Abandoned

United Kingdom0Started 2023-09-18

Plain-language 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.

Who can participate

Age range1 Month – 5 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

The accuracy of the system in 15 patients, when compared with the gold standard measurement system

Timeframe: 24 hours

The acceptability of the sensor to the child as viewed by the parent (and child)

Timeframe: End of study

Trial details

NCT IDNCT06093347

SponsorSheffield Children's NHS Foundation Trust

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-19

View on ClinicalTrials.gov More Sleep Apnea trials