Phase 4
N=13
SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE)
Chronic Fatigue Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02055898 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: EEG Slow Wave Activity During Sleep — 0.00002653; 0.00002257 uV^2/Hz
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sodium Oxybate (Drug); placebo (fresh potable water) (Other)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY EEG Slow Wave Activity During Sleep |
0.00003051; 0.00001759 | — |
| PRIMARY EEG Slow Wave Activity During Sleep |
0.00003051; 0.00001759 | — |
| PRIMARY Daytime Sleepiness |
17.9; 17.2 | — |
| PRIMARY Daytime Sleepiness |
17.9; 17.2 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT02055898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.