Condition: REM Sleep Behavior Disorder · Isolated REM Sleep Behavior Disorder · Sponsor: Universita di Verona
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…
This description comes directly from the study's public registry record.
Elena Antelmi, Md, PhD · +39 0458124290 · elena.antelmi@univr.it
Giacomo Carollo, MSc · giacomocarollo.2@gmail.com
Always discuss trial participation with your own doctor first.
| IRCCS Istituto delle Scienze Neurologiche di Bologna | Bologna, Emilia-Romagna, Italy | Recruiting |
| IRCCS Ospedale Policlinico San Martino | Genoa, Liguria, Italy | Recruiting |
| IRCCS Ospedale San Raffaele | Milan, Lombardy, Italy | Recruiting |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS | Pavia, Lombardy, Italy | Recruiting |
| Azienda Ospedaliero-Universitaria di Cagliari | Cagliari, Sardinia, Italy | Recruiting |
| I.R.C.C.S. Associazione Oasi Maria SS. - Ospedale Classificato | Troina, Sicily, Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana | Pisa, Tuscany, Italy | Recruiting |
| Azienda Ospedaliera Universitaria Integrata Verona | Verona, Veneto, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07498452