SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE) (SAFFE)
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|ClinicalTrials.gov Identifier: NCT02055898|
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : August 27, 2015
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.
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Slow-wave Sleep and Daytime Functioning in Chronic Fatigue Syndrome: Effects of Sodium Oxybate|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
All subjects will receive both sodium oxybate and placebo comparator in a crossover design
Drug: Sodium Oxybate
Other Name: Xyrem
Other: placebo (fresh potable water)
- EEG slow wave activity during sleep [ Time Frame: night 4 ]EEG activity during sleep will be analysed using spectral analysis, and total power in 0.5-4Hz band will be calculated and compared between placebo and drug nights for each patient.
- Daytime sleepiness [ Time Frame: day 5 ]The mean sleep latency on the Multiple Sleep Latency Test carried out on day 5 of each study period will be compared between drug and placebo periods for each patient
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055898
|Wellcome CRF, Imperial College, Hammersmith Campus|
|London, United Kingdom, W12 0NN|
|Principal Investigator:||David Nutt, DM FRCPsych||Imperial College London|