Status:
RECRUITING
Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
Lead Sponsor:
Acurable Ltd.
Collaborating Sponsors:
Sheffield Children's NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust
Conditions:
Sleep Apnea
Eligibility:
All Genders
1-18 years
Brief Summary
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. T...
Detailed Description
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. T...
Eligibility Criteria
Inclusion
- Children older than one year old
- Children who have been referred to a sleep clinic due to suspicion of sleep apnoea.
Exclusion
- 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.
- Clinical problem in the area in which the device will be attached, eg skin condition
Key Trial Info
Start Date :
February 19 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04031950
Start Date
February 19 2020
End Date
December 30 2025
Last Update
August 15 2025
Active Locations (2)
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1
Sheffield Children Hospital
Sheffield, United Kingdom, S10 2TH
2
Southampton Children's Hospital
Southampton, United Kingdom