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

Recruitingn/aAges any - anyAllUniversita di Verona
NCT07498452 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 lif

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients diagnosed with iRBD according to the International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria. * Patients who have had a follow-up visit within the previous 12 months. * Patients who provide informed consent to participate in the study. * Partners/family members of patients with iRBD who accept to participate. Exclusion Criteria: * Patients with RBD who have already phenoconverted to a neurodegenerative disorder. * Patients or partners/family members without access to an email address.
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What it tests

  • Not listed
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Where

8 sites
IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, Italy
IRCCS Ospedale Policlinico San Martino
Genoa, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, Italy
Azienda Ospedaliero-Universitaria di Cagliari
Cagliari, Italy
I.R.C.C.S. Associazione Oasi Maria SS. - Ospedale Classificato
Troina, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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