SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Imperial College London
Sponsor:
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT02055898
First received: December 13, 2013
Last updated: April 9, 2014
Last verified: November 2013
  Purpose

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 Intervention Phase
Chronic Fatigue Syndrome
Drug: Sodium Oxybate
Other: placebo (fresh potable water)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Slow-wave Sleep and Daytime Functioning in Chronic Fatigue Syndrome: Effects of Sodium Oxybate

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • EEG slow wave activity during sleep [ Time Frame: night 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 12
Study Start Date: April 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02055898

Contacts
Contact: Sue Wilson, PhD +44 207 594 4026 sue.wilson@imperial.ac.uk
Contact: Claire Durant, PhD +44 207 594 4026 c.durant@imperial.ac.uk

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

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02055898     History of Changes
Other Study ID Numbers: SAFFE2012, 2012-002969-35
Study First Received: December 13, 2013
Last Updated: April 9, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on August 28, 2014