ODESA
Research type
Research Study
Full title
On road Driving assessment and EEG signal recording in patients with suspected Sleep Apnoea
IRAS ID
314762
Contact name
I E Smith
Contact email
Sponsor organisation
Royal Papworth Hospital
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 7 months, 31 days
Research summary
Obstructive sleep apnoea (OSA) is a common breathing disorder that interrupts sleep and may affect daytime performance of complex tasks. Prior evidence from assessments of driving records and hospital emergency room attendances shows that people with untreated OSA are 3 times more likely to have a motor vehicle collision than other drivers or people with treated OSA. Worse performance has been shown on driving simulators but, this is yet to be confirmed with real world driving data and the causes of driving impairment, which elements of driving are affected and whether the issue has a dose relationship with OSA, are unknown. This lack of knowledge makes it difficult to advise on driving licence retention in the period between diagnosis and starting treatment and in the case of non or partial compliance with treatment. Many OSA patients rely on a driver’s licence for their independence, livelihood and wellbeing, however reducing motor vehicle collisions is of high importance to public safety.
The current study will assess the feasibility of a new methodology to simultaneously collect on-road driving performance data and neurological signals of arousal. Consenting patients will install a smartphone application which collects movement and orientation data that can be used to identify poor driving events (such as harsh braking), as well as overall driving performance scores on measures including ‘smoothness’ and ‘legality’ (adherence to speed limits). Simultaneously, a sub-group of participants will be asked to wear a head band device which will capture brain wave activity related to levels of alertness. The study is observational and will not affect any participant’s clinical care or treatment pathway. They will not be asked to undertake any journey that they would not have otherwise made. Comparisons will be made of driving performance and levels of alertness between people with and without OSA and within people with OSA, before and after treatment.
REC name
London - Harrow Research Ethics Committee
REC reference
23/LO/0405
Date of REC Opinion
30 May 2023
REC opinion
Further Information Favourable Opinion