Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
Recruiting now
Conditions studied: Sleep Apnea
In brief
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.
Key facts
- Study ID
- NCT04031950
- Run by
- Acurable Ltd.
- People needed
- 200
- Starts
- 2020-02-19
- Expected to finish
- 2025-12-30
- Last updated by the study team
- 2025-08-15
Who can join
Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Children older than one year old
- Children who have been referred to a sleep clinic due to suspicion of sleep apnoea.
You may not qualify if…
- 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
Where it is running
- Sheffield Children Hospital — Sheffield, United Kingdom (enrolling)
- Southampton Children's Hospital — Southampton, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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