Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine
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Randomized Controlled Trial
Effects of Suvorexant, an Orexin Receptor Antagonist, on Respiration during Sleep In Patients with Obstructive Sleep Apnea.
To investigate the respiratory effects of suvorexant, an orexin receptor antagonist for treating insomnia, in patients with obstructive sleep apnea (OSA). ⋯ clinicaltrials.gov, NCT01300455.
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Randomized Controlled Trial
Post Hoc Analysis of Data from Two Clinical Trials Evaluating the Minimal Clinically Important Change in International Restless Legs Syndrome Sum Score in Patients with Restless Legs Syndrome (Willis-Ekbom Disease).
Determine the minimal clinically important change (MCIC), a measure determining the minimum change in scale score perceived as clinically beneficial, for the international restless legs syndrome (IRLS) and restless legs syndrome 6-item questionnaire (RLS-6) in patients with moderate to severe restless legs syndrome (RLS/Willis-Ekbom disease) treated with the rotigotine transdermal system. ⋯ In patients with RLS, the MCIC values derived in the current analysis provide a basis for defining meaningful clinical improvement based on changes in the IRLS and RLS-6 following treatment with rotigotine.
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Randomized Controlled Trial
The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study.
This study examined the effects of milnacipran on polysomnographic (PSG) measures of sleep and subjective complaints in patients with fibromyalgia and disturbed sleep. ⋯ ClinicalTrials.gov, identifier: NCT01234675.
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One of the goals of the American Academy of Sleep Medicine (AASM) is to provide clear, evidence-based recommendations in our clinical practice guidelines. Periodically, the AASM will assess and update the process by which these guidelines are developed so that it is in line with the standards currently being used for guideline development. The AASM is now taking the next step forward by fully adopting GRADE (Grading of Recommendation Assessment, Development and Evaluation) as the methodology used for evaluating evidence and forming clinical practice guidelines recommendations. ⋯ In an effort to provide clarity and transparency, all AASM recommendations will be actionable statements that include the specific patient population for which the patient-care strategy is recommended, and clearly define the comparator against which the patient-care strategy was evaluated. In some recommendations, the comparator will be an alternative patient-care strategy (e.g., a "gold standard" or previously available alternative), while in other recommendations the comparator will be a placebo or no treatment; this is determined by the availability of evidence, and analyses decisions made by the AASM task force. Implementation of the complete GRADE criteria by the AASM allows us the best path forward towards continuing to provide high quality clinical practice guidelines.