Sleep medicine
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Multicenter Study
Weight loss in narcolepsy patients treated with sodium oxybate.
Narcolepsy is often associated with increased body weight. Sodium oxybate has efficacy in many narcolepsy symptoms. The purpose of this study was to evaluate the effects of sodium oxybate on weight in patients with narcolepsy. ⋯ This study suggests that treatment of patients with narcolepsy with sodium oxybate can result in weight loss.
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Randomized Controlled Trial Multicenter Study
Cardiac function after CPAP therapy in patients with chronic heart failure and sleep apnea: a multicenter study.
Continuous positive airway pressure (CPAP) is an effective treatment for sleep apnea (SA), although the evidence for improving chronic heart failure (CHF) is inconclusive. Our aim was to evaluate the effect of CPAP treatment on the left ventricle ejection fraction (LVEF) among other cardiological variables in a randomized, multicenter, placebo (sham-CPAP)-controlled study. ⋯ CPAP therapy proved to be useful in patients with associated sleep-disordered breathing and CHF. The improvement was more marked in patients with a LVEF>30%. However, the increased LVEF in the CPAP group was not accompanied by changes in the other cardiological variables.
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Randomized Controlled Trial Multicenter Study Comparative Study
Efficacy of the selective extrasynaptic GABA A agonist, gaboxadol, in a model of transient insomnia: a randomized, controlled clinical trial.
The hypnotic efficacy of gaboxadol, a selective extrasynaptic GABA A agonist (SEGA), was evaluated in a phase-advance model of transient insomnia. ⋯ Gaboxadol 10 and 15 mg were efficacious in significantly reducing the sleep maintenance and sleep onset disruption produced by this model of transient insomnia, with effects generally being most pronounced for the 15 mg dose. Gaboxadol also enhanced SWS.
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Multicenter Study Clinical Trial
A 52-week open-label study of the long-term safety of ropinirole in patients with restless legs syndrome.
To assess the long-term safety and efficacy of ropinirole in the treatment of patients with restless legs syndrome (RLS) over 52 weeks. ⋯ Ropinirole was well tolerated and therapeutic efficacy was maintained over 52 weeks in patients with RLS.
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Multicenter Study Clinical Trial
Validation of the Augmentation Severity Rating Scale (ASRS): a multicentric, prospective study with levodopa on restless legs syndrome.
Augmentation is the main complication during long-term dopaminergic treatment of restless legs syndrome (RLS) and reflects an overall increase in RLS severity. Its severity varies considerably from a minor problem to a devastating exacerbation of disease. Despite its clinical relevance, systematic evaluations have rarely been undertaken and there has been no development of methods to assess the severity of augmentation. To fill this gap, the European RLS Study Group (EURLSSG) has developed the Augmentation Severity Rating Scale (ASRS), using three items that assess the degree of change in three specific dimensions of augmentation. The changes in each dimension are summed to give an ASRS total score. ⋯ The ASRS is a reliable and valid scale to measure the severity of augmentation. Due to the need to systematically quantify augmentation for both long-term efficacy and tolerability, the ASRS may become a useful tool to monitor augmentation in future clinical trials.