Terms used in this evidence summary
Epworth Sleepiness Scale
The Epworth Sleepiness Scale (ESS) is a self-administered patient questionnaire with 8 questions asking how likely people are to doze off or fall asleep in 8 life situations, such as watching television. Each question is ranked 0=would never doze, 1=slight chance of dozing, 2=moderate chance of dozing, 3=high chance of dozing. The maximum score is 24, with higher scores indicating more chance of dozing off (Johns 1991). The minimum clinically important difference on this scale is 3 points (Dauvilliers 2013, European Public Assessment Report [EPAR] for pitolisant).
Maintenance of wakefulness test
The maintenance of wakefulness test (MWT) measures the ability of people to stay awake for a defined period of time. It consists of 4×40‑minute trials performed at 2‑hour intervals, with the first trial beginning about 1.5 to 3 hours after the person's usual wake-up time. The person is seated in bed in an otherwise dark room with a light source positioned slightly behind their head. The ability to stay awake is measured in minutes. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30‑second epoch. Trials are ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. Among normal control subjects, mean sleep latency to first epoch of sleep is about 30 minutes (Littner at al. 2005, van der Heide et al. 2015).
Sustained attention to response test
The sustained attention to response test (SART) is a computer-based task designed to measure a person's ability to withhold responses to infrequent and unpredictable stimuli during a period of rapid and rhythmic responding to frequent stimuli. For example, people are presented with the digits 1 to 9 in random order and they are asked to respond as quickly as possible by clicking the mouse, apart from when they see the number 3 when they must withhold the response. The task consists of a total of 225 trials (25 of each of the 9 digits) and lasts approximately 4 minutes. SART comprises of 3 error scores: the number of times the button was pressed inappropriately ('NO GO'; with a maximum count of 25), the number of times key pressing was missed ('GO'; with a maximum count of 200), and the sum of these 2 scores (Fronczek et al. 2006, Dauvilliers 2013, van der Heide et al. 2015). Lower scores indicating better attention levels.