Sleep quality, daytime sleepiness, fatigue, and quality of life in patients with multiple sclerosis treated with interferon beta-1b: results from a prospective observational cohort study

Sylvia Kotterba, Thomas Neusser, Christiane Norenberg, Patrick Bussfeld, Thomas Glaser, Martin Dörner, Markus Schürks, Sylvia Kotterba, Thomas Neusser, Christiane Norenberg, Patrick Bussfeld, Thomas Glaser, Martin Dörner, Markus Schürks

Abstract

Background: Sleep disorders and fatigue are common in multiple sclerosis (MS). The underlying causes are not fully understood, and prospective studies are lacking. Therefore, we conducted a prospective, observational cohort study investigating sleep quality, fatigue, quality of life, and comorbidities in patients with MS.

Methods: Patients with relapsing-remitting MS or clinically isolated syndrome treated with interferon beta-1b were followed over two years. The primary objective was to investigate correlations between sleep quality (PSQI), fatigue (MFIS), and functional health status (SF-36). Secondary objectives were to investigate correlations of sleep quality and daytime sleepiness (ESS), depression (HADS-D), anxiety (HADS-A), pain (HSAL), and restless legs syndrome (RLS). We applied descriptive statistics, correlation and regression analyses.

Results: 139 patients were enrolled, 128 were available for full analysis. The proportion of poor sleepers (PSQI≥5) was 55.47% at the beginning and 37.70% by the end of the study (106 and 41 evaluable questionnaires, respectively). Poor sleepers performed worse in MFIS, SF-36, ESS, HADS-D, and HADS-A scores. The prevalence of patients with RLS was low (4.5%) and all were poor sleepers. Poor sleep quality was positively correlated with fatigue and low functional health status. These relationships were corroborated by multivariable-adjusted regression analyses. ESS values and poor sleep quality at baseline seem to predict sleep quality at the one-year follow-up. No variable predicted sleep quality at the two-year follow-up.

Conclusions: Our results confirm the high prevalence of poor sleep quality among patients with MS and its persistent correlation with fatigue and reduced quality of life over time. They highlight the importance of interventions to improve sleep quality.

Trial registration: The study was registered at clinicaltrials.gov: NCT01766063 (registered December 7, 2012). Registered retrospectively (first patient enrolled December 6, 2012).

Keywords: Fatigue; Functional health status; Interferon beta-1b; Multiple sclerosis; Real world; Sleep quality.

Conflict of interest statement

Ethics approval and consent to participate

The Ethics Committee of the Medical Faculty of the University of Göttingen, Germany, approved the study (application number 12/8/12). All participants provided written informed consent to participate in the study.

Consent for publication

Not applicable.

Competing interests

SK received study grants from Bayer Vital GmbH and BiogenIdec, personal compensation as a speaker from Bayer Vital GmbH, BiogenIdec, UCB, Pfizer, and Novartis. TN, MD and MS are full-time employees of Bayer Vital GmbH. MS previously served as an associate editor to BMC Neurology. PB is a full-time employee of Bayer Consumer Care AG. TG is a former employee of Bayer Vital GmbH and currently a consultant to Bayer Vital GmbH. CN is a full-time employee of Bayer AG.

Publisher’s Note

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Figures

Fig. 1
Fig. 1
Course of fatigue (MFIS), functional health (SF-36), sleepiness (ESS), depression, and anxiety (HADS) throughout the study. Numbers of good sleepers (PSQIMFIS Modified Fatigue Impact Scale, SF-36 Short Form-36, PCS physical component score, MCS mental component score, ESS Epworth Sleepiness Scale, HADS Hospital Anxiety and Depression Scale.
Fig. 2
Fig. 2
Direction and strength of correlations between questionnaire results for primary and secondary outcome variables at the beginning of the study. PSQI Pittsburgh Sleep Quality Index, MFIS Modified Fatigue Impact Scale, SF-36 Short Form 36, PCS physical component score, MCS mental component score, ESS Epworth Sleepiness Scale, HADS-D Hospital Anxiety and Depression Scale Depression Subscale, HADS-A Hospital Anxiety and Depression Scale Anxiety Subscale

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