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SWS And daytime Functioning in chronic FatiguE syndrome (SAFFE)

  • Research type

    Research Study

  • Full title

    Slow-wave sleep and daytime functioning in chronic fatigue syndrome: effects of sodium oxybate

  • IRAS ID

    110603

  • Contact name

    David Nutt

  • Contact email

    d.nutt@imperial.ac.uk

  • Sponsor organisation

    Imperial College London

  • Eudract number

    2012-002969-35

  • ISRCTN Number

    n/a

  • Research summary

    Chronic fatigue syndrome (CFS), characterised by chronic disabling fatigue, sleep impairment and other symptoms, is associated with neither a currently identifiable disease process nor major psychiatric illness, and has an estimated prevalence in primary care of 1-2%. Sleep impairment is common in nearly everyone with CFS, with both daytime sleepiness and unrefreshing nighttime sleep reported, and consequent impact on daytime function. It may be that fundamental regulatory processes that control sleep are disturbed in CFS, leading to different effects on sleep and daytime symptoms depending on the subject’s prior sleep, daytime routine, medication and other factors. Our contacts with patient groups have indicated that patients are generally confident that on days when their sleep is better they perform better in the day. There is growing evidence that deep, slow wave sleep (SWS) is altered in CFS, and this may suggest impairment of build up of sleep pressure during the day.
    We wish to investigate whether enhancement of SWS, which is seen after a drug called sodium oxybate, reduces the impact of sleep disruption in CFS on daytime function, specifically sleepiness and mental performance. This is a safe and well-tolerated drug that is licensed for excessive daytime sleepiness (EDS) and cataplexy associated with narcolepsy.
    We will study 12 patients diagnosed with CFS using international diagnostic guidelines. We will record overnight sleep with EEG (brainwave) measurement on the 1st and 4th nights of a 4 night period during which sodium oxybate and placebo will be taken nightly, and we will measure next-day sleepiness, fatigue, mental performance and fatigue, and at compare drug and placebo nights.

  • REC name

    London - Brent Research Ethics Committee

  • REC reference

    13/LO/0882

  • Date of REC Opinion

    5 Jul 2013

  • REC opinion

    Favourable Opinion