Home based diagnostic testing for Narcolepsy V1.0
Research type
Research Study
Full title
A pilot observational study to assess the ability of continuous ‘home’ EEG to accurately diagnose narcolepsy
IRAS ID
321547
Contact name
Paul Gringras
Contact email
Sponsor organisation
Guy's and St Thomas' Foundation NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Narcolepsy (Type 1 and Type 2) is a rare neurological disorder affecting 1 in 2000-3000 individuals worldwide with onset often in childhood and adolescence. It manifests with excessive daytime sleepiness, hypnagogic hallucinations, sleep paralysis and cataplexy (the sudden loss of muscle tone usually precipitated by strong emotion).
Narcolepsy (Type 1 or 2) is one of several disorders of excessive sleepiness present in 4-6% of the population (Billiard M, 2003). Others include idiopathic hypersomnia, Kleine-Levin syndrome, behaviourally induced insufficient sleep syndrome and other hypersomnias. Accurate and timely diagnosis is important as each disorder has different treatment options, and if untreated are associated with significant health and socio-economical impacts.
Diagnosis is dependent upon a complicated sleep study to determine if the structure of sleep is normal, and if the young person falls asleep too easily. Traditionally this has been carried out in the sleep laboratory. This is expensive, resource heavy and during the COVID-19 crisis has been unavailable.
The Dreem Headband (DH) device is a novel sleep monitoring wearable device which uses measurement of brain electrical activity to determine sleep stages.
In this study we would ask young people who are being investigated for excessive sleepiness to wear the DH while undergoing the usual sleep studies required to diagnose narcolepsy. We would then compare the results of the DH to the results of the ‘gold standard’ test to find out if we can use the DH to develop a home based test for narcolepsy, and distinguish it from other causes of excessive sleepiness. This would allow cheap and timely testing in a natural and non-threatening environment.REC name
London - Surrey Borders Research Ethics Committee
REC reference
23/PR/0971
Date of REC Opinion
14 Sep 2023
REC opinion
Favourable Opinion