Validation of the post sleep questionnaire for assessing subjects with restless legs syndrome: results from two double-blind multicenter placebo-controlled clinical trials

摘要

BackgroundBecause of the subjective nature of Restless Legs Syndrome (RLS) symptoms and the impact of these symptoms on sleep, patient-reported outcomes (PROs) play a prominent role as study endpoints in clinical trials investigating RLS treatments. The objective of this study was to validate a new measure, the Post Sleep Questionnaire (PSQ), to assess sleep dysfunction in subjects with moderate-to-severe RLS symptoms.