Clinical evaluation of a paediatric sleep diagnosis technology
Research type
Research Study
Full title
Clinical evaluation of a paediatric wearable sleep diagnosis technology
IRAS ID
269747
Contact name
Emilio Sanz
Contact email
Sponsor organisation
Acurable
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Obstructive sleep apnoea (OSA) is a respiratory condition which affects up to 5% of children (20% if obese), and has recently become a major public health problem, since both its severity and incidence increase together with the obesity epidemic. In otherwise healthy children: 25% of children with sleep apnoea have hyperactivity/behavioural problems, and 18% of children performing in the lowest 10% of the first-grade have shown to have sleep apnoea. In 2012 the American Association of Paediatrics officially recommended to identify any child with sleep apnoea before undergoing surgery.
The currently accepted gold-standard for OSA diagnosis in children remains polysomnography (PSG). This is a very expensive and distressful test in which the child spends a night in a clinic, sleeps connected to a set of bulky sensors which measure different physiological signals, and subsequently needs up to 2h of expert interpretation. Because of this, it is not widely available and is only offered to a very small percentage of children.
The aim of this project is to clinically validate a new technology that aims to solve all of these problems: is very small, comfortable and trivial to use by parents themselves; does not suffer from de-attachment issues; provides automatic reliable diagnosis (no expert is needed at any point); and the output is different for different respiratory events.REC name
London - Stanmore Research Ethics Committee
REC reference
19/LO/1454
Date of REC Opinion
25 Oct 2019
REC opinion
Further Information Favourable Opinion