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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
Medical Research Council
Information provided by (Responsible Party):
Imperial College London

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.

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
Primary Completion Date : August 2015
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
All subjects
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)

Primary Outcome Measures :
  1. 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.

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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

United Kingdom
Wellcome CRF, Imperial College, Hammersmith Campus
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Imperial College London
Medical Research Council
Principal Investigator: David Nutt, DM FRCPsych Imperial College London

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02055898     History of Changes
Other Study ID Numbers: SAFFE2012
2012-002969-35 ( EudraCT Number )
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: November 2013

Additional relevant MeSH terms:
Fatigue Syndrome, Chronic
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Sodium Oxybate
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs