| Summary: | Dan Chen,1 Paula Shaw,2 Daniel M Canafax,1,3 James Catesby Ware4 1XenoPort, Inc., Santa Clara, CA, USA; 2Charles River Northwest, Tacoma, WA, USA; 3Theravance Inc., South San Francisco, CA, USA; 4Division of Sleep Medicine, Eastern Virginia Medical School, Norfolk, VA, USA Objective: Symptoms of restless legs syndrome (RLS) usually occur during the evening and night time, resulting in disrupted sleep and subsequent daytime fatigue. This study compared simulated driving performance, alertness, and cognitive function between healthy subjects and patients with a diagnosis of RLS. Methods: Fifteen healthy subjects and 15 untreated RLS subjects were enrolled and completed two driving tests. The first test occurred at 4 PM followed by the second test at 8 AM the next morning. Outcome measures included lane position variability (LPV), speed variability, frequency of simulated crashes (off-road events or collision), and brake reaction time. Other assessments included visual analog scale (VAS) of alertness and the Brief Assessment of Cognition (BAC). Results: Overall, RLS patients and healthy subjects performed similarly on driving assessments. Two subjects within each group experienced off-road events. RLS patients had less alertness on the VAS than healthy subjects before and after driving assessments. Both groups scored similarly on the cognitive function assessments. Conclusion: Despite reported diminished alertness, RLS patients did not demonstrate impairment in driving or cognitive performance. Keywords: restless legs syndrome, simulated driving performance, cognitive function
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