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Introduction The lived experiences of individuals with insomnia and comorbid nocturia are not properly understood. This study explored the lived experiences of individuals with insomnia and comorbid nocturia to identify relevant concepts that could be reflected in patient-reported outcome (PRO) endpoints in clinical studies. Methods This was a cross-sectional, qualitative observational study. Data were collected from a sample of 10 adult subjects from the US suffering from insomnia disorder (DSM-5) and comorbid nocturia (≥2 nocturnal voids). Interviews were conducted using semi-structured guides, lasted 60–90 minutes, and assessed patient-relevant concepts of interest for their insomnia and nocturia. Institutional review board approval and web-based informed consent were obtained prior to the interviews. Results Overall, 10 participants were included, and the mean age was 61 years (SD=6). Most participants were female (8/10), White (9/10), and lived with a partner/spouse, family, or friends (8/10). Almost all participants experienced insomnia symptoms at least 5 nights per week (9/10), most often impacting their emotional (10/10), social (10/10), physical (9/10), cognitive (9/10), and work and productivity (6/10) functioning. Almost all participants reported that decreasing the impact of insomnia would be meaningful (8/10), most often mentioning improvements in physical impacts such as having more energy or feeling less exhausted (7/10). All participants experienced nocturia at least 6 nights per week (10/10), often impacting their emotional (7/10), social (6/10), physical (6/10), cognitive (4/10), and work and productivity (4/10) functioning. Participants reported that going to the bathroom less often (i.e., two times per night, once per night, or not at all; each 2/10) and being able to sleep through the night (2/10) would be meaningful improvements. Conclusion Individuals with insomnia and nocturia experience disrupted sleep patterns that impact their emotional, social, physical, cognitive, and work functioning. Feeling less tired, being able to sleep through the night, and getting up less often to use the bathroom would be meaningful to patients living with both conditions. Support (if any) Funded by Idorsia Pharmaceuticals Ltd.

Introduction The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is validated to measure daytime functioning in individuals with insomnia disorder. This study assessed the content validity of the IDSIQ through cognitive interviews in individuals with insomnia and comorbid nocturia. Methods This was a cross-sectional, qualitative observational study. Data were collected from 10 adult subjects from the US suffering from insomnia disorder (DSM-5) and comorbid nocturia (≥2 nocturnal voids). One-on-one, web-based interviews were conducted using semi-structured guides and lasted 60–90 minutes. Based on the stage of the study, all participants examined the content validity of the IDSIQ as part of 1) hybrid concept elicitation and cognitive interviews (n=5; Stage 1), or 2) cognitive interviews (n=5; Stage 2). Institutional review board approval and web-based informed consent were obtained prior to the patient interviews. Results The mean age of participants was 59.5 years (SD=4.3) and 62.2 years (SD=8.5) in the hybrid and cognitive interview groups, respectively. All individuals in the hybrid interviews were female, whereas all individuals in the cognitive interviews were male. Participants’ overall impressions were positive (10/10), describing the IDSIQ as straightforward (5/10), good (1/10), simple (1/10), very precise (1/10), very specific (1/10), clear (1/10), and aligned with their experience (3/10). The items were understood by all participants (10/10) except Item 1, which was understood by almost all participants (9/10). One participant suggested that the responses to questions on the IDSIQ may vary depending on the time the survey is administered, and the amount of sleep obtained the previous night. All 10 participants reported that they could answer all questions. Of the nine participants who were asked, all stated that the IDSIQ was relevant to their experience of their condition. Most participants reported that there were no missing items, whereas two participants stated that an item assessing the impact of insomnia on personal relationships (including family) was missing. Conclusion The content of the IDSIQ was easy to understand by patients that suffer from insomnia and comorbid nocturia. The study provides evidence for the content validity of the IDSIQ and its applicability in this population. Support (if any) Funded by Idorsia Pharmaceuticals Ltd.