SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE) (SAFFE)
Chronic Fatigue Syndrome
About this trial
This is an interventional other trial for Chronic Fatigue Syndrome focused on measuring Chronic fatigue syndrome
Eligibility 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
Sites / Locations
- Wellcome CRF, Imperial College, Hammersmith Campus
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Placebo first, then sodium oxybate
Sodium oxybate first, then placebo
Subjects received a single dose of placebo comparator (fresh potable water) at bedtime on 4 nights during an inpatient stay of 5 days in the research centre. This was followed by an interval of at least 2 weeks. They were then admitted again and received a single dose of sodium oxybate (3.0g as liquid) at bedtime for 4 nights
Subjects received a single dose of sodium oxybate (3.0g as liquid) at bedtime on 4 nights during an inpatient stay of 5 days in the research centre. This was followed by an interval of at least 2 weeks. They were then admitted again and received a single dose of placebo comparator (fresh potable water) at bedtime for 4 nights