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Previous studies have demonstrated that night-shift work is associated with adverse effects impacting physical and psychological health, including the Shift Work Disorder (SWD). SWD is a circadian rhythm disorder characterized by sleepiness and insomnia, resulting from working a shift other than the traditional daytime-shift. Armodafinil, a modafinil longer-lasting R-isomer, is approved for SWD treatment. Due to its pharmacodynamic profile, it may result in more sustained wakefulness during night-shifts than Modafinil.
Objectives
To conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing the efficacy of Armodafinil vs Modafinil and/or placebo on reducing SWD excessive sleepiness.
Methods
Will follow PRISMA guidelines. A systematic search will be conducted on PubMed, Web of Science, Scopus and ClinicalTrials.gov databases. RCTs comparing Armodafinil with Modafinil and/or Placebo for SWD treatment will be included. No language nor date restrictions will be applied. Outcomes of interest are prespecified as follows: the primary endpoint will be objective sleepiness; secondary endpoints will include subjective sleepiness, adverse effects, awareness, reaction time, memory and cognition. Retrieved studies will be independently screened for eligibility by two reviewers. Disagreements will be solved by consensus or by a third reviewer. Primary studies methodological quality will be assessed and data extracted independently using a standardized extraction-form.
Results
Data will be described and reported as narrative text and summary tables. Heterogeneity of the included studies will be assessed and, if possible, a meta-analysis will be conducted.
Conclusions
It is expected that this systematic review and meta-analysis favours Armodafinil over Modafinil and placebo in the treatment of SWD.
This chapter reviews pharmacological options that may improve the impaired wakefulness associated with shift work disorder (SWD) and available data regarding the use of stimulant therapy. It begins with a brief discussion of shift work and SWD. Night shift workers are at a greater risk for workplace accidents than day shift workers. Research into the negative physical and mental effects of shift work is accumulating, and available evidence indicates that shift work is associated with greater risk of psychiatric problems, cardiovascular disorders, cancer, and accidents, and it represents a serious occupational health problem. A variety of countermeasures have been proposed and studied for the treatment of sleepiness and daytime sleep disturbances associated with shift work. These countermeasures range from basic nonpharmacological and behavioral strategies for improving sleep quality and quantity to pharmacological interventions for improving alertness during the work period or for improving sleep during the sleep period.
Shift work disrupts circadian and homeostatic sleep regulation and is probably the most common cause of sleepiness in society. This chapter talks about the shift work disorder, and presents survey studies of sleepiness, physiological sleepiness and momentary subjective sleepiness. EEG measures give some indication of the pattern of sleepiness in relation to shift work, that is, incidents of sleep intrusions are frequently seen during the second half of a night shift. If sleepiness is as pronounced as suggested in connection with night work, there should be a link with performance errors and accidents. Shift work that includes night shifts causes high levels of sleepiness that may constitute a major safety risk, particularly in transport work, but also in health care and industry. The chapter discusses the individual differences, the diagnosis shift work disorder, and possible ways of counteracting or treating intolerance to shift work.
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