Unmet needs of people with isolated REM sleep behavior disorder and their partners
Exploring Unmet Needs Among Patients With Isolated REM Sleep Behavior Disorder (iRBD) and Their Significant Others: A Multicenter Cross-Sectional Survey Study
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Sex | All |
| Sponsor | Universita di Verona Academic / other |
| Locations | 8 sites (Bologna, Emilia-Romagna and 7 other locations) |
| Trial ID | NCT07498452 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bologna, Emilia-Romagna and 7 other locations
- 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)
Study contacts
- Study coordinator: Elena Antelmi, Md, PhD
- Email: elena.antelmi@univr.it
- Phone: +39 0458124290
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.