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Effect of armodafinil on cortical activity and working memory in patients with residual excessive sleepiness associated with CPAP-Treated OSA: a multicenter fMRI study.

Publication ,  Journal Article
Greve, DN; Duntley, SP; Larson-Prior, L; Krystal, AD; Diaz, MT; Drummond, SPA; Thein, SG; Kushida, CA; Yang, R; Thomas, RJ
Published in: J Clin Sleep Med
February 15, 2014

STUDY OBJECTIVE: 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. METHODS: 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. RESULTS: 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%). CONCLUSIONS: Armodafinil did not improve fMRI-measured functional brain activation in CPAP-treated patients with OSA and excessive sleepiness. STUDY REGISTRATION: 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.

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Published In

J Clin Sleep Med

DOI

EISSN

1550-9397

Publication Date

February 15, 2014

Volume

10

Issue

2

Start / End Page

143 / 153

Location

United States

Related Subject Headings

  • Young Adult
  • Wakefulness-Promoting Agents
  • Treatment Outcome
  • Sleep Apnea, Obstructive
  • Prospective Studies
  • Neurology & Neurosurgery
  • Modafinil
  • Middle Aged
  • Memory, Short-Term
  • Male
 

Citation

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Greve, D. N., Duntley, S. P., Larson-Prior, L., Krystal, A. D., Diaz, M. T., Drummond, S. P. A., … Thomas, R. J. (2014). 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, 10(2), 143–153. https://doi.org/10.5664/jcsm.3440
Greve, Douglas N., Stephen P. Duntley, Linda Larson-Prior, Andrew D. Krystal, Michele T. Diaz, Sean P. A. Drummond, Stephen G. Thein, Clete A. Kushida, Ronghua Yang, and Robert J. Thomas. “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 10, no. 2 (February 15, 2014): 143–53. https://doi.org/10.5664/jcsm.3440.
Greve DN, Duntley SP, Larson-Prior L, Krystal AD, Diaz MT, Drummond SPA, et al. 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 Feb 15;10(2):143–53.
Greve, Douglas N., et al. “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, vol. 10, no. 2, Feb. 2014, pp. 143–53. Pubmed, doi:10.5664/jcsm.3440.
Greve DN, Duntley SP, Larson-Prior L, Krystal AD, Diaz MT, Drummond SPA, 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 Feb 15;10(2):143–153.

Published In

J Clin Sleep Med

DOI

EISSN

1550-9397

Publication Date

February 15, 2014

Volume

10

Issue

2

Start / End Page

143 / 153

Location

United States

Related Subject Headings

  • Young Adult
  • Wakefulness-Promoting Agents
  • Treatment Outcome
  • Sleep Apnea, Obstructive
  • Prospective Studies
  • Neurology & Neurosurgery
  • Modafinil
  • Middle Aged
  • Memory, Short-Term
  • Male