Central Apnoea Monitor Study
Recruiting
- Conditions
- Sleep Apnea
- Registration Number
- NCT06093347
- Lead Sponsor
- Sheffield Children's NHS Foundation Trust
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The accuracy of the system in 15 patients, when compared with the gold standard measurement system 24 hours The acceptability of the sensor to the child as viewed by the parent (and child) End of study As measured by researcher designed questionnaire
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Research Facility, Sheffield Children's Hospital
🇬🇧Sheffield, United Kingdom