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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  • Additional Information
    • Source:
      Publisher: BioMed Central Country of Publication: England NLM ID: 100968555 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2377 (Electronic) Linking ISSN: 14712377 NLM ISO Abbreviation: BMC Neurol Subsets: MEDLINE
    • Publication Information:
      Original Publication: London : BioMed Central, [2001-
    • Subject Terms:
      Adjuvants, Immunologic/*therapeutic use ; Interferon beta-1b/*therapeutic use ; Multiple Sclerosis, Relapsing-Remitting/*drug therapy ; Sleep Wake Disorders/*epidemiology; Adult ; Aged ; Cohort Studies ; Fatigue/epidemiology ; Fatigue/etiology ; Female ; Humans ; Male ; Middle Aged ; Multiple Sclerosis, Relapsing-Remitting/complications ; Prevalence ; Prospective Studies ; Quality of Life ; Retrospective Studies ; Sleep/drug effects ; Sleep Wake Disorders/etiology ; Surveys and Questionnaires ; Young Adult
    • 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).
    • References:
      Mult Scler. 2013 Apr;19(4):480-9. (PMID: 22914848)
      Mult Scler Int. 2014;2014:872732. (PMID: 24734182)
      Sleep Med. 2017 Feb;30:57-63. (PMID: 28215264)
      Expert Rev Neurother. 2010 Sep;10(9):1437-47. (PMID: 20819014)
      PLoS One. 2014 Aug 25;9(8):e104604. (PMID: 25153835)
      Mult Scler. 2010 Feb;16(2):238-47. (PMID: 20028705)
      Health Qual Life Outcomes. 2013 Jul 29;11:127. (PMID: 23895207)
      Neurology. 2014 Sep 9;83(11):1022-4. (PMID: 25200713)
      Mult Scler. 2011 May;17(5):613-22. (PMID: 21278050)
      BMC Neurol. 2017 Sep 6;17(1):174. (PMID: 28877664)
      PLoS One. 2012;7(11):e49996. (PMID: 23166808)
      Neurol Sci. 2013 Aug;34(8):1291-6. (PMID: 23109097)
      Mult Scler. 2015 Mar;21(3):342-9. (PMID: 25533301)
      Clin Neurol Neurosurg. 2013 Dec;115 Suppl 1:S82-5. (PMID: 24321163)
      Semin Neurol. 2005 Mar;25(1):64-8. (PMID: 15798938)
      Sleep Med. 2014 Jan;15(1):5-14. (PMID: 24360534)
      Mult Scler. 2017 Jan;23(1):5-13. (PMID: 27503906)
      Acta Neurol Scand. 2004 Jul;110(1):6-13. (PMID: 15180801)
      Neurology. 2012 May 8;78(19):1500-6. (PMID: 22539566)
      Mult Scler. 2001 Oct;7(5):340-4. (PMID: 11724451)
      Eur Neurol. 2012;68(1):8-15. (PMID: 22627080)
      Brain Res. 2004 Nov 19;1027(1-2):117-25. (PMID: 15494163)
    • Contributed Indexing:
      Keywords: Fatigue; Functional health status; Interferon beta-1b; Multiple sclerosis; Real world; Sleep quality
    • Molecular Sequence:
      ClinicalTrials.gov NCT01766063
    • Accession Number:
      0 (Adjuvants, Immunologic)
      145155-23-3 (Interferon beta-1b)
    • Publication Date:
      Date Created: 20180826 Date Completed: 20181031 Latest Revision: 20181114
    • Publication Date:
      20250114
    • Accession Number:
      PMC6107945
    • Accession Number:
      10.1186/s12883-018-1113-5
    • Accession Number:
      30143019