Unmet Needs Among Patients With Isolated REM Sleep Behavior Disorder (iRBD) and Their Significant Others

The goal of this observational study is to explore the unmet needs and the psychosocial impact of isolated REM Sleep Behavior Disorder (iRBD) on patients and their significant others. Isolated REM Sleep Behavior Disorder is a sleep disorder characterized by dream-enactment behaviors during REM sleep and is increasingly recognized as a prodromal condition associated with neurodegenerative diseases. Despite growing clinical attention, little is known about the informational, emotional, and practical needs experienced by patients and their caregivers. The main questions this study aims to answer are: What are the main unmet informational, psychological, and clinical needs reported by patients with isolated REM Sleep Behavior Disorder? What are the main challenges and support needs experienced by their significant others or caregivers? How does the diagnosis of iRBD affect quality of life, emotional well-being, and perceptions of future health risks for both patients and caregivers? This is a multicenter cross-sectional observational study conducted in several sleep and movement disorders centers. The study aims to collect structured information directly from patients and their significant others in order to better understand their experiences, concerns, and expectations regarding the disease and its management. Participants will be asked to: complete an online questionnaire about their experience with isolated REM Sleep Behavior Disorder, including perceived needs, access to information, and interactions with healthcare services; report information about emotional well-being, quality of life, and concerns related to the possible future progression of the disorder; caregivers or significant others will complete a parallel questionnaire focused on their experiences, caregiving burden, informational needs, and perceived support. The information collected in this study will help clinicians and researchers better understand the real-world needs of individuals living with isolated REM Sleep Behavior Disorder and their families. The results may contribute to improving patient education, clinical care pathways, and support services for this population.

NCT Number	NCT07498452
Lead Sponsor	Universita di Verona
Conditions	REM Sleep Behavior Disorder, Isolated REM Sleep Behavior Disorder
Enrollment	150 participants
Start Date	2025-05-06
Primary Completion	2026-05 (estimated)
Study Completion	2026-08 (estimated)
Updated on ClinicalTrials.gov	2026-03-27