Assessment methodologies in sleep medicine clinical trials

Author(s): Elena A Wood,W Vaughn McCall

Clinical trials in sleep medicine cover a wide range of sleep–wake problems, and accordingly the selection of outcome measures in sleep medicine clinical trials needs to be tailored to the specific disorder under examination. This review describes the measures most commonly used in sleep medicine clinical trials, weighing the relative merits of a self-report questionnaire versus a physiologic test as the a priori primary outcome measures.