Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
ConditionSleep Apnea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorAcurable Ltd.
About this trial
The objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population.
The Study will involve patients who will have been referred for diagnosis of sleep apnoea, and the ultimate aim will be to compare the output of a novel apnoea detection system against in -clinic polysomnography.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children older than one year old
Children who have been referred to a sleep clinic due to suspicion of sleep apnoea.
Disqualifiers
Patients whose parents/legal guardians/carers are not fluent in English, or who have special communication needs.
Known allergy to the adhesive dressing.
Patients with physical or mental impairments who would be too distressed with additional sensors on themselves.
Patients with not enough space on the neck area to fit the sensor.
Trial population
all children who have been referred for a sleep test.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Novel wearable paediatric device
DeviceThe patient will wear the novel wearable paediatric device at the same time as polysmnography
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: test group1 intervention
Group B: Novel wearable device1 intervention
Trial outcomes
Primary outcomes
1
Specificity and sensitivity of novel device
specificity and sensitivity of the output of the novel wearable device against polysomnography
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Acurable Ltd.
Lead sponsor
Sheffield Children's NHS Foundation Trust
Collaborator
University Hospital Southampton NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov