OBJECTIVE: @entity239 ( @entity239 ) is associated with the sleep phenomenon of alpha intrusion, and with low growth hormone secretion. @entity15221 has been shown to increase both slow-wave sleep and growth hormone levels. This double blind, randomized, placebo controlled crossover trial was conducted to evaluate the effects of @entity15221 on the subjective symptoms of @entity158 and the objective polysomnographic (PSG) sleep variables of alpha intrusion, slow-wave (stage 3/4) sleep, and sleep efficiency in @entity1 with @entity239 . METHODS: @entity1 received either 6.0 g/day @entity15221 or placebo for 1 month, with an intervening 2 week washout period. Efficacy measures included PSG evaluations, tender point index (TPI), and subjective measurements from daily diary entries. Safety measures included clinical laboratory values, vital signs, and adverse events. RESULTS: Twenty-four female @entity1 were included in the study; 18 completed the trial. TPI was decreased from baseline by 8.5, compared with an increase of 0.4 for placebo (p = 0.0079). Six of the 7 @entity158 / @entity1295 scores (overall @entity158 , @entity158 at rest, @entity158 during movement, end of day @entity1295 , overall @entity1295 , and morning @entity1295 ) were relieved by 29% to 33% with @entity15221 , compared with 6% to 10% relief with placebo (p < 0.005). Alpha intrusion, sleep latency, and @entity11755 were significantly decreased, while slow-wave (stage 3/4) sleep was significantly increased, compared with placebo (p < 0.005). Two of the 5 subjective sleep related variables were significantly different from placebo: morning alertness (improved by 18% with @entity15221 , compared with 2% for placebo; p = 0.0033) and quality of sleep (improved by 33% and 10%, respectively; p = 0.0003). CONCLUSION: @entity15221 effectively reduced the symptoms of @entity158 and @entity1295 in @entity1 with @entity239 , and dramatically reduced the @entity25 (alpha intrusion and decreased slow-wave sleep) associated with the nonrestorative sleep characteristic of this disorder.

The effects of XXXX on clinical symptoms and sleep patterns in @entity1 with @entity239 .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity239 :: ('MESH:D005356', 'Disease') :: ['Fibromyalgia', 'FM'] @entity15221 :: ('MESH:D012978', 'Chemical') :: ['Sodium oxybate', 'sodium oxybate'] @entity1295 :: ('MESH:D005221', 'Disease') :: ['fatigue'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain', 'pain, fatigue, and sleep quality'] @entity11755 :: ('MESH:D020187', 'Disease') :: ['rapid-eye-movement sleep'] @entity25 :: ('MESH:D012893', 'Disease') :: ['sleep abnormalities']
@entity15221 :: (MESH:D012978,Chemical) :: ['sodium oxybate']
