Abstract

Abstract 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.

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