The Doppler Feasibility Study

Sheffield Children's NHS Foundation Trust11 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Heart Rate Measurements

Eligibility

Sex: ALLMin age: 1 MonthMax age: 12 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Clinical Research Facility, Sheffield Children's Hospital

Sheffield, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 1 hour

The acceptability of the sensor to the child as viewed by the parent

As measured by researcher designed questionnaire

Time frame: 1 hour

Data from ClinicalTrials.gov

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