Effect of Armodafinil on Cortical Activity and Working Memory in Patients with Residual Excessive Sleepiness Associated with CPAP-Treated OSA: A Multicenter fMRI Study
1Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Charlestown, MA; 2Washington University School of Medicine, Department of Neurology, St. Louis, MO; 3Washington University School of Medicine, Department of Radiology, St. Louis, MO; 4Duke University Medical Center, Durham, NC; 5Duke University Medical Center, Brain Imaging and Analysis Center, Durham, NC; 6University of California and Veterans Affairs San Diego Healthcare System, San Diego, CA; 7Pacific Research Network, Inc., San Diego, CA; 8Stanford School of Medicine, Stanford Sleep Medicine Center, Redwood City, CA; 9Teva Branded Pharmaceutical Products R&D, Inc., Frazer, PA; 10Beth Israel Deaconess Medical Center, Boston, MA
To assess the effect of armodafinil on task-related prefrontal cortex activation using functional magnetic resonance imaging (fMRI) in patients with obstructive sleep apnea (OSA) and excessive sleepiness despite continuous positive airway pressure (CPAP) therapy.
This 2-week, multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-group study was conducted at five neuroimaging sites and four collaborating clinical study centers in the United States. Patients were 40 right-handed or ambidextrous men and women aged between 18 and 60 years, with OSA and persistent sleepiness, as determined by multiple sleep latency and Epworth Sleepiness Scale scores, despite effective, stable use of CPAP. Treatment was randomized (1:1) to once-daily armodafinil 200 mg or placebo. The primary efficacy outcome was a change from baseline at week 2 in the volume of activation meeting the predefined threshold in the dorsolateral prefrontal cortex during a 2-back working memory task. The key secondary measure was the change in task response latency.
No significant differences were observed between treatment groups in the primary or key secondary outcomes. Armodafinil was generally well tolerated. The most common adverse events (occurring in more than one patient [5%]) were headache (19%), nasopharyngitis (14%), and diarrhea (10%).
Armodafinil did not improve fMRI-measured functional brain activation in CPAP-treated patients with OSA and excessive sleepiness.
Double-Blind, Placebo-Controlled, Functional Neuroimaging Study of Armodafinil (200 mg/Day) on Prefrontal Cortical Activation in Patients With Residual Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea. ClinicalTrials.gov Identifier: NCT00711516. http://www.clinicaltrials.gov/ct2/show/study/NCT00711516
Greve DN; Duntley SP; Larson-Prior L; Krystal AD; Diaz MT; Drummond SP; Thein SG; Kushida CA; Yang R; Thomas RJ. Effect of armodafinil on cortical activity and working memory in patients with residual excessive sleepiness associated with CPAP-treated OSA: a multicenter fMRI study. J Clin Sleep Med 2014;10(2):143-153.
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