SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE)

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Collaborator: Medical Research Council
• Treatments: Sodium Oxybate

Criteria

Inclusion criteria

• Meeting criteria for CFS according to both the revised CDC (Fukuda 5) and Canadian diagnostic systems.

• Aged 25-65.

• Good grasp of the English language.

Exclusion criteria

• Taking any of the following medication: opioids, tramadol, phenytoin, valproate, ethosuximide, benzodiazepines, zolpidem, zopiclone, zaleplon, antidepressant except <30mg amitriptyline, or any other medications likely to interact with sodium oxybate or with sleep in the opinion of the investigators.

• Current major psychiatric disorder.

• Unusual sleep schedule; (bedtime routines that fall outside 9 p.m. to 10 a.m.; usual time in bed > 12 hours).

• Pregnancy, lactation or being female and not using reliable contraception.

• Relevant abnormal clinical findings at screening visit.

• Taken alcohol in the 24 hours before each study visit or drugs of abuse in the week before each study visit