RECRUITINGOBSERVATIONAL
Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Children older than one year old
- Children who have been referred to a sleep clinic due to suspicion of sleep apnoea.
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Children older than one year old
* Children who have been referred to a sleep clinic due to suspicion of sleep apnoea.
Exclusion Criteria:
* 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
Treatments Being Tested
DEVICE
Novel wearable paediatric device
The patient will wear the novel wearable paediatric device at the same time as polysmnography
Locations (2)
Sheffield Children Hospital
Sheffield, United Kingdom
Southampton Children's Hospital
Southampton, United Kingdom