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

Primary Purpose

Chronic Fatigue Syndrome

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Sodium Oxybate
placebo (fresh potable water)
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Fatigue Syndrome focused on measuring Chronic fatigue syndrome

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wellcome CRF, Imperial College, Hammersmith Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Placebo first, then sodium oxybate

Sodium oxybate first, then placebo

Arm Description

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

Outcomes

Primary Outcome Measures

EEG Slow Wave Activity During Sleep
Total power in 0.5-4Hz band in microvolts squared per Hertz (uV^2/Hz)
EEG Slow Wave Activity During Sleep
Total power in 0.5-4Hz band in microvolts squared per Hertz (uV^2/Hz)
Daytime Sleepiness
time to fall asleep in minutes
Daytime Sleepiness
time to fall asleep in minutes

Secondary Outcome Measures

Full Information

First Posted
December 13, 2013
Last Updated
October 27, 2020
Sponsor
Imperial College London
Collaborators
Medical Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT02055898
Brief Title
SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE)
Acronym
SAFFE
Official Title
Slow-wave Sleep and Daytime Functioning in Chronic Fatigue Syndrome: Effects of Sodium Oxybate
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Medical Research Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome
Keywords
Chronic fatigue syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo first, then sodium oxybate
Arm Type
Experimental
Arm Description
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
Arm Title
Sodium oxybate first, then placebo
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Sodium Oxybate
Other Intervention Name(s)
Xyrem
Intervention Type
Other
Intervention Name(s)
placebo (fresh potable water)
Primary Outcome Measure Information:
Title
EEG Slow Wave Activity During Sleep
Description
Total power in 0.5-4Hz band in microvolts squared per Hertz (uV^2/Hz)
Time Frame
night 1
Title
EEG Slow Wave Activity During Sleep
Description
Total power in 0.5-4Hz band in microvolts squared per Hertz (uV^2/Hz)
Time Frame
night 4
Title
Daytime Sleepiness
Description
time to fall asleep in minutes
Time Frame
Day 2
Title
Daytime Sleepiness
Description
time to fall asleep in minutes
Time Frame
Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Nutt, DM FRCPsych
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wellcome CRF, Imperial College, Hammersmith Campus
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE)

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