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

• ClinicalTrials.gov Identifier: NCT02055898
• Recruitment Status: Completed
• First Posted: February 5, 2014
• Last Update Posted: August 27, 2015
• Sponsor: Imperial College London
• Collaborator: Medical Research Council
• Information provided by (Responsible Party): Imperial College London

Tracking Information

• First Submitted Date: December 13, 2013
• First Posted Date: February 5, 2014
• Last Update Posted Date: August 27, 2015
• Study Start Date: April 2014
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT02055898 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE)
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Condition: Chronic Fatigue Syndrome

Intervention

• Drug: Sodium Oxybate
  Other Name: Xyrem
• Other: placebo (fresh potable water)

Study Arms

All subjects

All subjects will receive both sodium oxybate and placebo comparator in a crossover design

Interventions:

• Drug: Sodium Oxybate
• Other: placebo (fresh potable water)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 26, 2015): 10
• Original Estimated Enrollment (submitted: February 4, 2014): 12
• Actual Study Completion Date: August 2015
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT02055898
• Other Study ID Numbers: SAFFE2012; 2012-002969-35 ( EudraCT Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Imperial College London
• Study Sponsor: Imperial College London
• Collaborators: Medical Research Council

Investigators

• Principal Investigator: David Nutt, DM FRCPsych; Imperial College London

• PRS Account: Imperial College London
• Verification Date: November 2013