Background: Patients with multiple sclerosis (MS) frequently suffer from comorbid conditions with sleep disorders affecting about 50% of patients. Further, sleep disorders may cause fatigue, a prominent MS symptom, in up to 80% of patients. Available studies on the role of sleep disorders in MS are heterogeneous and prospective studies also investigating potential underlying reasons for sleep disorders among MS patients are lacking. Sleep disorders may represent a disease–specific feature among MS patients or may be confounded by comorbid conditions, MS treatment, and duration of treatment. Finally, data on diagnostic and treatment patterns of comorbid conditions in MS patients with sleep disorders and the impact of treatment on sleep disorders over time are unavailable.
Aim: Better understanding the characteristics, comorbidities, diagnostic and treatment patterns, and course of sleep disorders in MS patients in a real-life setting in Germany. The primary objective is to investigate the correlations between sleep quality, fatigue, and functional health status among MS patients treated with Interferon beta–1b (Betaferon®).
Methods: BETASLEEP is a prospective, non–interventional, multi–center, observational cohort study conducted in neurological offices/neurology departments throughout Germany specialized in MS treatment. Patients with RRMS or CIS and EDSS score≤5, who have been treated with Betaferon® ≤6 months and are tolerating Betaferon® according to their attending physician, may be enrolled. Treatment with any other disease–modifying drugs (DMD) or MS specific drugs is not permitted. It is planned to enroll a total of 300 patients, which will be followed up over 2 years with desired documentation every 6 months. Assessment tools for the comorbid conditions include the Pittsburgh Sleep Quality Index (PSQI), the Modified Fatigue Impact Scale (MFIS), the Short Form–36 (SF–36), the Epworth Sleepiness Scale (ESS), the Hospital anxiety and depression scale (HADS), the Hamburg Pain Adjective List (Hamburger Schmerz Adjektiv Liste (HSAL)), and the IRLSS group rating scale. All analyses will be exploratory and of descriptive character. The BETASLEEP study started in December 2012. At present 132 patients (August 2014) have been enrolled in centers throughout Germany. Enrollment is ongoing and will continue until December 2014. Hence, follow-up will last until December 2016. Discussion:Analysis of the characteristics and comorbidities of MS patients with sleep disorders as well as the diagnostic and treatment patterns of these sleep disorders and their course may facilitate individualized and targeted treatment in the future..