Unmet needs of people with isolated REM sleep behavior disorder and their partners
Official title: Exploring Unmet Needs Among Patients With Isolated REM Sleep Behavior Disorder (iRBD) and Their Significant Others: A Multicenter Cross-Sectional Survey Study
Run by Universita di Verona · NCT07498452 · Data updated 2026-11-12
This project asks people with isolated REM sleep behavior disorder (iRBD) and their significant others about their informational, emotional, and practical needs using online questionnaires.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Universita di Verona Academic / other |
| Locations | 8 sites (Bologna, Emilia-Romagna and 7 other locations) |
| Status | Recruiting |
| Started | May 6, 2025 |
| Main results expected | May 2026 |
| Study ends | August 2026 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT07498452 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults diagnosed with isolated REM sleep behavior disorder per ICSD-3 who had a follow-up visit within the past 12 months and can provide informed consent, along with their partners or family members willing to participate, are ideal candidates.
✕Probably not a fit
Patients who have already phenoconverted to a neurodegenerative disorder or individuals without access to an email address are unlikely to benefit from or be able to participate in this project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter cross-sectional observational project collects structured questionnaire data from patients diagnosed with iRBD and from their partners or family members. Participants are recruited through several Italian sleep and movement disorder centers and complete surveys via an online platform. Questionnaires cover informational needs, psychosocial burden, quality of life, emotional well-being, and perceptions of future health risks. The goal is to map unmet needs to guide better patient-centered communication and support services.
Why it matters
Potential benefit: If successful, the results could lead to improved communication, targeted support services, and better patient-centered care for people with iRBD and their caregivers.
How similar studies have gone: While caregiver and needs assessments exist for Parkinson's disease and dementia, focused observational work on unmet needs specifically in iRBD is relatively limited and therefore more novel than well-established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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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
Show 2 more locations
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Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy Recruiting -
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Veneto, Italy Recruiting
Study contacts
- Study coordinator: Elena Antelmi, Md, PhD
- Email: elena.antelmi@univr.it
- Phone: +39 0458124290
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.