NCT06093347WithdrawnNot Applicable
Feasibility Study to Evaluate a New Wearable Wireless Device for Monitoring Central Apnoeas in Infants and Children
Sheffield Children's NHS Foundation Trust1 site in 1 country15 target enrollmentStarted: September 18, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- The accuracy of the system in 15 patients, when compared with the gold standard measurement system
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 1 Month to 5 Years (Child)
- Sex
- 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).
Outcomes
Primary Outcomes
The accuracy of the system in 15 patients, when compared with the gold standard measurement system
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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