Vasculaire Leg Compression Device for the Treatment of Restless Legs Syndrome - A Prospective Clinical Study

Restless legs syndrome (RLS) is a debilitating sleep disorder that has significant impact on quality of life, and often times can be difficult to diagnose and treat effectively. RLS is typically treated with medical therapy (including dopaminergic agents, dopamine agonists, benzodiazepines, anticonvulsants, opiates, among other therapies). Many patients are either refractory to medical therapy, have contraindications or adverse reactions to the available medical therapies, or desire conservative non-medication based therapies. Two previous studies have demonstrated that pneumatic compression devices placed on the legs can improve symptoms of RLS. We would like to assess whether the Venous Health Systems Vasculaire leg compression device improves symptoms and quality of life measures related to RLS in up to 40 patients evaluated prospectively for one month. This is a pilot study to assess the subjective response of our cohort of patients to this device prospectively. Our hypothesis is that over 66% of our cohort will demonstrate a positive symptomatic response based on RLS specific quality of life questionnaires.