0464 The Impact of Fatigue and Sleepiness on Patients with OSA: A Closer Look with Patient Reported Outcome Measures

Abstract Introduction Qualitative interviews were conducted to understand experiences of individual with OSA by evaluating the content validity and relevance of 5 patient reported outcome (PRO) measures (PROMIS-Fatigue-8a, the PROMIS-Sleep Impairment-8a, the Epworth Sleepiness Scale (ESS), Patient-Global Impression of Severity (PGI-S)-Fatigue, and Patient-Global Impression of Change (PGI-C)-Fatigue). Methods 3 US sites identified individuals with OSA. Once consented, participants completed an interview containing concept elicitation and cognitive debriefing questions. Interviews were recorded, transcribed, and analyzed using qualitative software. Symptoms and impacts were mapped to the PROs, and a gap analysis was conducted. The study was approved by WCG IRB. Results 30 individuals with OSA (20 current non-PAP users [mean age=55; 50% male] and 10 current PAP users [mean age=52, 80% male]) were interviewed. Non-PAP and PAP users viewed fatigue and feeling sleepy as separate, distinct symptoms. Among non-PAP users the most common symptoms were fatigue (100%), difficulty concentrating (85%), feeling sleepy (75%), dry mouth (60%), interrupted sleep (50%), and headaches (50%). Fatigue (63%) was most bothersome, while 5% rated feeling sleepy as most bothersome. Among PAP users the most common symptoms were fatigue (100%), feeling sleepy (90%), difficulty concentrating (60%), dry mouth/throat (60%), headaches (50%), and interrupted sleep (50%). Fatigue (63%) was most bothersome, while 25% rated feeling sleepy as most bothersome. Non-PAP and PAP users reported negative impacts on daily activities (50% both), physical (60% and 50%, respectively), social (50% both), and emotional functioning (80% and 60%), and relationships (75% and 70%). Impacts on ability to work for pay and work productivity (45% and 70%) were also common. PAP users reported improvements on their ability to do daily activities (80%) and all areas of functioning after initiating PAP (range: 80-100%). In general, participants found these PROs to be clear and appropriate. Fatigue and sleepiness were two of the most common symptoms cited; these concepts are comprehensively covered by these PROs. Conclusion Fatigue and sleepiness should both be assessed in OSA trials and clinical practice. This study provides evidence to support the content validity, clarity, and relevance of the PROMIS-Fatigue-8a, PROMIS-Sleep Impairment-8a, ESS, PGI-S-Fatigue, and PGI-C-Fatigue PROs in an adult OSA population. Support (if any) Funded by Apnimed.