SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE)

GHB

Brief 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.

Intervention / Treatment

  • Sodium Oxybate (DRUG)
    N/A
  • placebo (fresh potable water) (OTHER)
    N/A

Condition or Disease

  • Chronic Fatigue Syndrome

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 25 Years to 65 Years
    Enrollment: 13 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Other

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Apr 01, 2014
    Primary Completion: Aug 01, 2015 ACTUAL
    Completion Date: Aug 01, 2015 ACTUAL
    Study First Posted: Feb 05, 2014 ESTIMATED
    Results First Posted: Nov 18, 2020 ACTUAL
    Last Updated: Oct 27, 2020

    Sponsors / Collaborators

    Lead Sponsor: Imperial College London
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    London, England, United Kingdom

    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.

    Participant Groups

    • Subjects received a single dose of placebo comparator (fresh potable water) at bedtime on 4 nights during an inpatient stay of 5 days in the research centre. This was followed by an interval of at least 2 weeks. They were then admitted again and received a single dose of sodium oxybate (3.0g as liquid) at bedtime for 4 nights

    • Subjects received a single dose of sodium oxybate (3.0g as liquid) at bedtime on 4 nights during an inpatient stay of 5 days in the research centre. This was followed by an interval of at least 2 weeks. They were then admitted again and received a single dose of placebo comparator (fresh potable water) at bedtime for 4 nights

    Eligibility Criteria

    Sex: All
    Minimum Age: 25
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Total power in 0.5-4Hz band in microvolts squared per Hertz (uV\^2/Hz)

    • Total power in 0.5-4Hz band in microvolts squared per Hertz (uV\^2/Hz)

    • time to fall asleep in minutes

    • time to fall asleep in minutes

    More Details

    NCT Number: NCT02055898
    Acronym: SAFFE
    Other IDs: SAFFE2012
    Study URL: https://clinicaltrials.gov/study/NCT02055898
    Last updated: Sep 29, 2023