Does increasing slow wave sleep with a drug called sodium oxybate improve daytime function in people with chronic fatigue syndrome?

• Conditions: Chronic fatigue syndrome; MedDRA version: 16.0Level: PTClassification code 10008874Term: Chronic fatigue syndromeSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-002969-35-GB
• Lead Sponsor: Imperial College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-19
• Last Update Posted: 23 September 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Meeting criteria for CFS according to both the revised CDC and Canadian diagnostic systems
Aged 25-65
Good grasp of the English language

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Taking medication which interferes with sodium oxybate metabolism including tramadol, phenytoin, valproate, or medication that would interfere with sleep including benzodiazepines, Z hypnotics, antidepressant except <30mg amitryptyline
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The principal research question is to determine whether pharmacological enhancement of slow-wave sleep with sodium oxybate improves sleep maintenance and reduces the impact of sleep disruption in chronic fatigue syndrome on daytime function, specifically sleepiness and cognitive function. ;Secondary Objective: The secondary objectives are to determine whether pharmacological enhancement of slow-wave sleep with sodium oxybate in chronic fatigue syndrome is associated with changes in: subjectively rated sleep, sleepiness and mood; neuropsychological functioning; and muscle fatigue.<br>;Primary end point(s): Difference in slow-wave activity between sodium oxybate and placebo on night 4<br>Difference between sodium oxybate and placebo on MSLT on day 5<br>;Timepoint(s) of evaluation of this end point: Night 4 and day 5.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Differences between placebo and active drug on<br>•Slow-wave sleep and slow wave activity on night 1<br>•All other stages of sleep on all nights<br>•Subjectively rated sleep, sleepiness and mood<br>•Neuropsychological tests (CANTAB)<br>•Dynamometer measures of muscle fatigue<br>;Timepoint(s) of evaluation of this end point: All nights and day 5.