Loading clinical trials...
Loading clinical trials...
The Effect of Sodium Oxybate in Patients With Chronic Fatigue Syndrome.
Chronic fatigue syndrome (CFS) is a disabling, unexplained disorder characterized by physical and mental exhaustion. Complaints of disturbed and unrefreshing sleep are very common in CFS patients, however, the relationship between (disturbed) sleep quality and fatigue is still not fully elucidated. To evaluate the effect of sodium oxybate on fatigue and to explore the interdependence of sleep quality and fatigue in CFS, a double blind, randomized, placebo controlled cross-over trial with sodium oxybate is carried out in CFS patients. The aim of this study is to address the issue of the effect of sodium oxybate on fatigue as a presenting symptom in chronic fatigue (CF) and CFS patients, in the absence of underlying medical or psychiatric illness. The answer to this question may shed further light on the enigmatic relationship between sleep and fatigue. We also want to investigate the effect of sodium oxybate on sleepiness and general health in the same target population. Zero-hypothesis: there is no effect.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Ghent University Hospital
Ghent, Belgium
Start Date
June 1, 2013
Primary Completion Date
June 1, 2015
Completion Date
December 1, 2015
Last Updated
December 15, 2022
Sodium oxybate
DRUG
Placebo
DRUG
Lead Sponsor
University Hospital, Ghent
Collaborators
NCT04542161
NCT03759522
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions