The Doppler Feasibility Study
Completed
- Conditions
- Heart Rate Measurements
- Registration Number
- NCT06093373
- Lead Sponsor
- Sheffield Children's NHS Foundation Trust
- Brief Summary
The study is an exploratory research study looking at the feasibility, acceptability and accuracy of a doppler device compared with the gold standard ECG. It will take place in the sleep unit at Sheffield Children's Hospital.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
Inclusion Criteria
- Patients who have been referred for a cardio-respiratory polygraphy sleep study.
- Patients aged one month up to one year 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 ECG 1 hour The acceptability of the sensor to the child as viewed by the parent 1 hour 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