This study was funded by the UK Medical Research Council. https://www.clinicaltrials.gov/ct2/show/study/NCT02055898 Study Description Brief Summary: The investigators 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. The investigators will study 12 patients diagnosed with CFS using international diagnostic guidelines. The investigators 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 the investigators will measure next-day sleepiness, mental performance and fatigue, and compare drug and placebo nights. Condition or disease Intervention/treatment Phase Chronic Fatigue Syndrome Drug: Sodium Oxybate Other: placebo (fresh potable water) Phase 4 Detailed Description: 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. The investigators 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.
I don't think any paper has ever been published but I just noticed that some results were posted here in 2020 https://www.clinicaltrials.gov/ct2/show/results/NCT02055898?view=results
Interesting to see that the study was carried out by David Nutt, who is in favour of legalising psychoactive drugs. https://en.wikipedia.org/wiki/David_Nutt
I don't understand why this study was done. It seems to be based on the assumption that fatigue is the same as daytime sleepiness.
I assume this was one of the 6 biomedical studies that got funded after the MRC put out a call around 10 years ago. https://meassociation.org.uk/2012/0...jects-medical-research-council-12-april-2012/ It always seemed strange they never seemed to publish results
The fundamental problem with this study appears to me that it assumes that improved daytime funcytoning is caused by improved sleep, or vice versa. My 42 years experience have led me to believe that, although there may be a correlation ,both are caused by something else.
