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      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

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          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).

          Electronic supplementary material

          The online version of this article (10.1186/s12883-018-1113-5) contains supplementary material, which is available to authorized users.

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          Most cited references22

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          Sleep quality in the general population: psychometric properties of the Pittsburgh Sleep Quality Index, derived from a German community sample of 9284 people.

          The Pittsburgh Sleep Quality Index (PSQI) is frequently used to assess sleep problems in patients. The aim of this study was to provide reference values for this questionnaire, to test psychometric properties, and to analyze associations with psychological, sociodemographic, and behavioral factors.
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            Quality of life in multiple sclerosis: the impact of depression, fatigue and disability.

            This study deals with the assessment of quality of life and its main clinical and demographical determinants in a clinical series of 103 patients with multiple sclerosis (MS) (37 men; 66 women; mean age 44.89 years; mean disease duration 12.40 years; mean EDSS score 4.07). We used the MSQOL-54 inventory, a disease-specific instrument recently validated in an Italian population. Each patient underwent a complete clinical assessment, including that of disability status (Expanded Disability Status Scale), cognitive function (Mini Mental State Examination), depression (Hamilton Rating Scale for Depression) and fatigue (Fatigue Severity Scale). In terms of Pearson's correlations, there was a moderate inverse relationship between disability level and the MSQOL-54 physical composite score, and a moderate to strong inverse correlation between depression or fatigue severity and both the physical and mental composite scores. In a stepwise linear regression analysis, depression, fatigue and disability level were confirmed to be significant and independent predictors of quality of life. Quality of life instruments can help to provide a broader measure of the disease impact and to develop a care program tailored to the patient's needs.
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              Factors influencing quality of life in multiple sclerosis patients: disability, depressive mood, fatigue and sleep quality.

              In a series of 504 patients with multiple sclerosis (MS), quality of life (QOL) and its main clinical and demographic determinants were assessed in comparison with healthy individuals. A postal questionnaire with self-completed measures of disability (Expanded Disability Status Scale, EDSS), QOL (Quality of Life Index, QLI), depressive mood (Self-rating Depression Scale, SDS), fatigue severity (Fatigue Severity Scale, FSS) and sleep quality (Pittsburgh Sleep Quality Index, PSQI) was sent to this sample of MS patients. Most patients were severely disabled; almost half were mildly to severely depressed, suffering from reduced sleep quality and/or fatigue. The multiple sclerosis patients had significantly lower QLI scores than healthy controls. EDSS and SDS scores were found to be predictors of global QLI score. Regarding the different QLI domains, mean SDS scores remained predictive for all QLI items, while mean EDSS, PSQI and FSS scores were only predictive for physical domains. Our study clearly demonstrates that depressive mood is the main factor influencing QOL. The disability status, fatigue and reduced sleep quality have an impact mainly on physical domains of life quality.
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                Author and article information

                Contributors
                sylvia.kotterba@rub.de
                thomas.neusser@bayer.com
                christiane.norenberg@bayer.com
                patrick.bussfeld@bayer.com
                thomas.glaser@bayer.com
                martin.doerner@bayer.com
                markus.schuerks@bayer.com
                Journal
                BMC Neurol
                BMC Neurol
                BMC Neurology
                BioMed Central (London )
                1471-2377
                24 August 2018
                24 August 2018
                2018
                : 18
                : 123
                Affiliations
                [1 ]Klinik für Geriatrie, Klinikum Leer gemeinnützige GmbH, Leer, Germany
                [2 ]ISNI 0000 0004 0374 4101, GRID grid.420044.6, Bayer Vital GmbH, ; Leverkusen, Germany
                [3 ]ISNI 0000 0004 0374 4101, GRID grid.420044.6, Bayer AG, ; Wuppertal, Germany
                [4 ]ISNI 0000 0004 0519 4932, GRID grid.483721.b, Bayer Consumer Care AG, ; Basel, Switzerland
                Author information
                http://orcid.org/0000-0002-0477-8288
                Article
                1113
                10.1186/s12883-018-1113-5
                6107945
                30143019
                fd2e4b88-7cdc-49a4-afde-0bb968f5ca45
                © The Author(s). 2018

                Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 29 March 2018
                : 31 July 2018
                Funding
                Funded by: Bayer Vital GmbH, Leverkusen, Germany
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2018

                Neurology
                multiple sclerosis,interferon beta-1b,sleep quality,fatigue,functional health status,real world

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