Sleep Apnea
Conditions
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. 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.
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. 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. Patients who are referred to the clinic will spend one night's sleep in the clinic. They will wear a polysomnography system (current goldstandard) and the novel device. At the end of the trial, we will compare the diagnosis results from both systems.
Interventions
DEVICENovel wearable paediatric device
The patient will wear the novel wearable paediatric device at the same time as polysmnography
Sponsors
Sheffield Children's NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust
Acurable Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specificity and sensitivity of novel device | 6 months | specificity and sensitivity of the output of the novel wearable device against polysomnography |
Countries
United Kingdom
Contacts
Primary ContactOrsina Dessi, MEng
Outcome results
None listed