Acute placebo-controlled sleep laboratory studies and clinical follow-up with XXXX in @entity4531 .

@entity1 @entity308 @entity935 @entity148 @entity4531 @entity399 @entity25 @entity214
In a single-blind, placebo-controlled crossover trial, the acute efficacy of the @entity935 agonist @entity399 was investigated in 11 @entity4531 ( @entity4531 ) @entity1 by sleep laboratory methods, with a clinical follow-up for 4 weeks. In 3 nights (pre-treatment, placebo and drug night), objective @entity25 was determined by polysomnography (PSG), subjective sleep and awakening quality by rating scales, objective awakening quality by psychometry. Clinical follow-up consisted of completion of the International @entity4531 Study Group (IRLSSG) Scale, Zung @entity308 ( @entity214 ) and @entity148 (SAS) Scale, Quality of Life Index, Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale. Concerning acute effects, an omnibus significance test for PSG variables demonstrated a global difference between placebo and @entity399 , but none between pre-treatment and placebo. @entity399 0.27 mg significantly decreased the target variable periodic leg movements (PLM)/h of sleep as well as all other @entity4531 /PLM variables and improved objective sleep efficiency and subjective @entity25 as compared with placebo. In @entity25 , sleep stages S1 and S2 and stage shifts increased, while slow-wave sleep and SREM decreased. After 4 weeks of therapy, the total scores of the IRLSSG questionnaire, @entity25 and @entity25 , @entity308 and quality of life also improved. Thus, acute @entity399 markedly reduced PLM measures and slightly improved objective and subjective @entity25 . Follow-up ratings showed a moderate improvement of @entity4531 and @entity25 , and to a lesser extent of @entity25 , @entity308 and quality of life. The psychopathological findings as well as acute @entity25 changes are reminiscent of those seen after activating antidepressants.
