OpiSleep
Research type
Research Study
Full title
Opicapone and Sleep: a Pragmatic Real-Life Study
IRAS ID
232190
Contact name
Kallol Ray Chaudhuri
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This is an observational, pragmatic real-life study which will investigate the effectiveness of Opicapone (OPC) in reducing nocturnal sleep disturbance and Early Morning Off (EMO) in Parkinson's disease (PD) EMO refers to the state when patients experience Parkinson's symptoms (Off state) such as slowness, rigidity and/ or tremors upon waking up from sleep. It is an investigator initiated academic study, led by Prof Chaudhuri at King's College Hospital.
Non-motor symptoms, including sleep disorder have been recognized to affect the quality of life in patients with PD. Previous studies involving dopaminergic therapies have shown beneficial effects on sleep in PD. Thus, OPC, a long-acting Catechol-O-methyltransferase (COMT) inhibitor, which is prescribed for wearing off phenomenon, would theoretically exert similar clinical effect. Therefore, this observational study is performed to look at the possible effect of OPC on sleep disturbances in PD.
It is real-life in design and initiation of OPC will be purely a clinical decision made separately from the consideration for inclusion in this study. Eligible patients who are on OPC and reporting sleep disturbance will be subjected to standard validated questionnaires and scales as well as Parkinson's KinetiGraph (PKG) recording at baseline and will be followed up regularly over a year.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
19/EM/0297
Date of REC Opinion
11 Nov 2019
REC opinion
Further Information Favourable Opinion