title: Transdermal Rotigotine Improves Sleep Fragmentation in Parkinson's Disease: Results of the Multicenter, Prospective SLEEP-FRAM Study.
abstract: Sleep disturbances occur frequently in patients with Parkinson's disease (PD). The aim of this study was to investigate the effects of rotigotine on sleep fluctuations in a sample of PD patients with self-reported complaints of nocturnal awakenings. This prospective, open-label, observational, and multicenter study enrolled consecutive outpatients with PD and administered rotigotine (mean dose 8.9 mg/day) for 3 months. The primary endpoint was the change from baseline in sleep fragmentation, assessed using the sleep maintenance subscale score of the Parkinson's Disease Sleep Scale (PDSS). The newly designed Parkinson's Disease Sleep Fragmentation Questionnaire (PD-SFQ) was used to measure other sleep parameters. A total of 62 patients were enrolled (mean age 70.2 years; 66% male). At 3 months, rotigotine significantly improved sleep fragmentation from baseline on the PDSS-2 sleep maintenance subscale (from 3.4 ± 0.9 to 1.9 ± 1.4; P < 0.0001). Rotigotine also significantly improved nocturnal motor symptoms (P < 0.0001), restless legs-like symptoms (P < 0.005), and nocturia (P = 0.004). Rotigotine significantly improved self-reported complaints of sleep fragmentation in PD patients and could be a useful treatment to improve this specific sleep problem in PD. However, these results are based on a small and clinically heterogeneous sample so they must be taken cautiously.
authors: Hospital de la Santa Creu i Sant Pau, 08041 Barcelona, Spain.
authors: Javier
authors: J
authors: Pagonabarraga
authors: Hospital Santa Maria de Lleida, 25007 Lleida, Spain.
authors: Gerard
authors: G
authors: Piñol
authors: Hospital Santa Maria de Lleida, 25007 Lleida, Spain.
authors: Adriana
authors: A
authors: Cardozo
authors: Hospital de Mataró, 08302 Barcelona, Spain.
authors: Pilar
authors: P
authors: Sanz
authors: Hospital del Mar, 08003 Barcelona, Spain.
authors: Víctor
authors: V
authors: Puente
authors: Hospital de Granollers, 08401 Barcelona, Spain.
authors: Pilar
authors: P
authors: Otermín
authors: Hospital Son Espases, 07120 Barcelona, Spain.
authors: Inés
authors: I
authors: Legarda
authors: Corporació Sanitària Parc Taulí, 08208 Barcelona, Spain.
authors: Tania
authors: T
authors: Delgado
authors: Hospital de Martorell, 08760 Martorell, Spain.
authors: Carmen
authors: C
authors: Serrano
authors: Hospital General de Catalunya, 08915 Barcelona, Spain.
authors: Ernest
authors: E
authors: Balaguer
authors: Hospital de Figueres, 17600 Girona, Spain.
authors: María
authors: M
authors: Aguirregomozcorta
authors: Hospital Germans Trias i Pujol, 07014 Barcelona, Spain.
authors: Ramiro
authors: R
authors: Álvarez
authors: Hospital de la Santa Creu i Sant Pau, 08041 Barcelona, Spain.
authors: Jaime J
authors: JJ
authors: Kulisevsky