title: Effects of armodafinil on simulated driving and self-report measures in obstructive sleep apnea patients prior to treatment with continuous positive airway pressure.
abstract: OBJECTIVE
  Obstructive sleep apnea (OSA) has been associated with an increased risk of motor vehicle crashes. This driving risk can be reduced (≥ 50%) by treatment with continuous positive airway pressure (CPAP). However residual excessive daytime sleepiness (EDS) can persist for some patients who regularly use CPAP. The current study was designed to assess the effect of armodafinil on simulated driving performance and subsequent CPAP treatment compliance in newly diagnosed OSA patients with EDS during a 2-week "waiting period" prior to initiation of CPAP.
  
  
  METHODS
  Sixty-nine newly diagnosed OSA patients, awaiting CPAP therapy, were randomized (1:1) to placebo or armodafinil (150 mg/day) treatment. Simulated driving tests and self-report measures were completed at baseline, after 2 weeks of drug treatment, and following 6 weeks of CPAP treatment. CPAP compliance was evaluated at the end of 6 weeks of CPAP.
  
  
  RESULTS
  Compared to placebo, armodafinil improved simulated driving safety performance in OSA patients awaiting CPAP therapy (p = 0.03). Improvement was seen in lane position deviation (p = 0.002) and number of lane excursions (p = 0.02). Improvement was also observed on measures of sleepiness using the Epworth Sleepiness Scale (ESS) and sleep related quality of life. Following 6 weeks of CPAP, there was also significant improvement observed on multiple measures of simulated driving performance. CPAP compliance did not differ between armodafinil-treated and placebo-treated patients (p = 0.80).
  
  
  CONCLUSIONS
  Armodafinil was found to improve simulated driving performance in OSA patients with EDS prior to initiation of CPAP. Treatment with armodafinil showed no effect on subsequent CPAP compliance.
authors.affiliation: Cognitive Research Corporation, St Petersburg, FL, USA. gkay@cogres.com
authors.forename: Gary G
authors.initials: GG
authors.lastname: Kay
authors.forename: Neil
authors.initials: N
authors.lastname: Feldman
mesh_terms: D000328:Adult; D001334:Automobile Driving / Q000706:statistics & numerical data*; D001559:Benzhydryl Compounds / Q000494:pharmacology*; D003198:Computer Simulation; D045422:Continuous Positive Airway Pressure / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D000077408:Modafinil; D010349:Patient Compliance / Q000706:statistics & numerical data; D011597:Psychomotor Performance / Q000187:drug effects; D057566:Self Report; D020181:Sleep Apnea, Obstructive / Q000628:therapy*; D016896:Treatment Outcome; D014851:Wakefulness / Q000187:drug effects; D064690:Wakefulness-Promoting Agents / Q000494:pharmacology*
chemical_list: D001559:Benzhydryl Compounds; D064690:Wakefulness-Promoting Agents; D000077408:Modafinil
keywords: CPAP; ESS; OSA; armodafinil; driving simulation