title: Espresso Coffee for the Treatment of Somnolence in Parkinson's Disease: Results of n-of-1 Trials.
abstract: There is limited information available concerning the treatment of daytime somnolence associated with Parkinson's disease (PD); the most frequently applied therapeutic strategies include decreasing the dose of dopamine agonists or adding potential wake-promoting agents. There is recent data from a placebo-controlled trial concluding on a non-significant trend in favor of caffeine. We aimed to evaluate the efficacy of espresso-coffee in the treatment of daytime somnolence in PD. To evaluate the efficacy of espresso-coffee in the treatment of daytime somnolence in PD, we have conducted multiple single-patient (n-of-1) clinical trials comparing regular espresso coffee to decaffeinated coffee in PD patients presenting moderate to severe daytime somnolence defined as an Epworth Sleepiness Scale score >9. Each single-patient (n-of-1) trial included a sequence of three crossovers (two treatment periods separated by two days of washout). Four patients were included in the studies and three completed the three pairs of treatment periods. In two of the four patients, espresso coffee was considered beneficial. This study concludes that multiple single patient trials are feasible in PD and suggests that espresso-coffee may have a beneficial effect on daytime somnolence in some patients. These results cannot be generalized beyond the patients included in these trials.
authors.affiliation: Clinical Pharmacology Unit, Faculty of Medicine, Instituto de Medicina Molecular, University of Lisbon, Lisbon, Portugal; Laboratory of Clinical Pharmacology and Therapeutics, Faculty of Medicine, University of Lisbon, Lisbon, Portugal.
authors.forename: Joaquim J
authors.initials: JJ
authors.lastname: Ferreira
authors.affiliation: Clinical Pharmacology Unit, Faculty of Medicine, Instituto de Medicina Molecular, University of Lisbon , Lisbon , Portugal.
authors.forename: Tiago
authors.initials: T
authors.lastname: Mestre
authors.affiliation: Clinical Pharmacology Unit, Faculty of Medicine, Instituto de Medicina Molecular, University of Lisbon , Lisbon , Portugal.
authors.forename: Leonor Correia
authors.initials: LC
authors.lastname: Guedes
authors.affiliation: Clinical Pharmacology Unit, Faculty of Medicine, Instituto de Medicina Molecular, University of Lisbon , Lisbon , Portugal.
authors.forename: Miguel
authors.initials: M
authors.lastname: Coelho
authors.affiliation: Clinical Pharmacology Unit, Faculty of Medicine, Instituto de Medicina Molecular, University of Lisbon, Lisbon, Portugal; Laboratory of Clinical Pharmacology and Therapeutics, Faculty of Medicine, University of Lisbon, Lisbon, Portugal.
authors.forename: Mário M
authors.initials: MM
authors.lastname: Rosa
authors.affiliation: Clinical Pharmacology Unit, Faculty of Medicine, Instituto de Medicina Molecular, University of Lisbon , Lisbon , Portugal.
authors.forename: Ana T
authors.initials: AT
authors.lastname: Santos
authors.affiliation: Clinical Pharmacology Unit, Faculty of Medicine, Instituto de Medicina Molecular, University of Lisbon , Lisbon , Portugal.
authors.forename: Márcio
authors.initials: M
authors.lastname: Barra
authors.affiliation: Clinical Pharmacology Unit, Faculty of Medicine, Instituto de Medicina Molecular, University of Lisbon, Lisbon, Portugal; Laboratory of Clinical Pharmacology and Therapeutics, Faculty of Medicine, University of Lisbon, Lisbon, Portugal.
authors.forename: Cristina
authors.initials: C
authors.lastname: Sampaio
authors.affiliation: Departments of Clinical Pharmacology and Neurosciences, University Hospital of Toulouse and Clinical Investigation Center INSERM CIC9302 and UMR825, University of Toulouse III , Toulouse , France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Rascol
keywords: Parkinson’s disease; caffeine; daytime sleepiness; n-of-1 trials; sleep