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SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE) (SAFFE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02055898
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : August 27, 2015
Medical Research Council
Information provided by (Responsible Party):
Imperial College London

Tracking Information
First Submitted Date  ICMJE December 13, 2013
First Posted Date  ICMJE February 5, 2014
Last Update Posted Date August 27, 2015
Study Start Date  ICMJE April 2014
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2014)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02055898 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE)
Official Title  ICMJE Slow-wave Sleep and Daytime Functioning in Chronic Fatigue Syndrome: Effects of Sodium Oxybate
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Condition  ICMJE Chronic Fatigue Syndrome
Intervention  ICMJE
  • Drug: Sodium Oxybate
    Other Name: Xyrem
  • Other: placebo (fresh potable water)
Study Arms  ICMJE All subjects
All subjects will receive both sodium oxybate and placebo comparator in a crossover design
  • Drug: Sodium Oxybate
  • Other: placebo (fresh potable water)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2015)
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2014)
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02055898
Other Study ID Numbers  ICMJE SAFFE2012
2012-002969-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Imperial College London
Study Sponsor  ICMJE Imperial College London
Collaborators  ICMJE Medical Research Council
Investigators  ICMJE
Principal Investigator: David Nutt, DM FRCPsych Imperial College London
PRS Account Imperial College London
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP