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Clinical Trial NCT07498452 for REM Sleep Behavior Disorder, Isolated REM Sleep Behavior Disorder is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Unmet Needs Among Patients With Isolated REM Sleep Behavior Disorder (iRBD) and Their Significant Others 150 Real-World Evidence Observational High Unmet Need

Recruiting
Clinical Trial NCT07498452 is an observational study for REM Sleep Behavior Disorder, Isolated REM Sleep Behavior Disorder that is recruiting. It started on May 6, 2025 with plans to enroll 150 participants. Led by Universita di Verona, it is expected to complete by August 1, 2026. The latest data from ClinicalTrials.gov was last updated on March 27, 2026.
Brief Summary
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 cli...Show More
Detailed Description
Isolated REM Sleep Behavior Disorder (iRBD) is a parasomnia characterized by the loss of normal REM sleep atonia and the presence of dream-enactment behaviors. Over the last two decades, increasing evidence has shown that iRBD represents one of the strongest clinical prodromal markers of synucleinopathies, including Parkinson's disease, dementia with Lewy bodies, and multiple system atrophy. As a consequence, individ...Show More
Official Title

Exploring Unmet Needs Among Patients With Isolated REM Sleep Behavior Disorder (iRBD) and Their Significant Others: A Multicenter Cross-Sectional Survey Study

Conditions
REM Sleep Behavior DisorderIsolated REM Sleep Behavior Disorder
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • UN-RBD/SO
NCT ID Number
NCT07498452
Start Date (Actual)
2025-05-06
Last Update Posted
2026-03-27
Completion Date (Estimated)
2026-08
Enrollment (Estimated)
150
Study Type
Observational
Status
Recruiting
Keywords
iRBD
REM Sleep Behavior Disorder
Prodromal Parkinsonism
Patient Needs
Sleep Disorders
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Patients with isolated REM Sleep Behavior Disorder
Individuals diagnosed with isolated REM Sleep Behavior Disorder who participate in the study by completing an online questionnaire assessing informational needs, psychosocial impact, quality of life, and experiences related to the diagnosis.
N/A
Caregivers or significant others of patients with isolated REM Sleep Behavior Disorder
Caregivers or significant others of patients with isolated REM Sleep Behavior Disorder who complete a parallel questionnaire, informational needs, and perceived support.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Unmet informational, clinical, and psychosocial needs in patients with isolated REM Sleep Behavior Disorder and their significant others
Assessment of unmet informational, clinical, and psychosocial needs in individuals diagnosed with isolated REM Sleep Behavior Disorder and in their significant others using a structured online questionnaire administered in participating centers. The questionnaire explores domains including disease-related knowledge, access to information, interactions with healthcare services, perceived support needs, emotional well-being, and concerns about future disease progression.
Baseline (single assessment at questionnaire completion)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Identification of areas for improvement in healthcare services and informational resources for patients with isolated REM Sleep Behavior Disorder
Identification of areas where patients with isolated REM Sleep Behavior Disorder and their significant others report unmet needs related to healthcare services, access to information, clinical communication, and support resources, based on responses to structured survey questions administered during the study.
Baseline (single assessment at questionnaire completion)
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All
  • 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.

  • Patients with RBD who have already phenoconverted to a neurodegenerative disorder.
  • Patients or partners/family members without access to an email address.
Universita di Verona logoUniversita di Verona
Study Responsible Party
Elena Antelmi, Principal Investigator, Principal Investigator, Universita di Verona
Study Central Contact
Contact: Elena Antelmi, Md, PhD, +39 0458124290, [email protected]
Contact: Giacomo Carollo, MSc, [email protected]
8 Study Locations in 1 Countries

Emilia-Romagna

IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Emilia-Romagna, 40139, Italy
Giuseppe Plazzi, Md, PhD, Contact, +39 051 4966924, [email protected]
Recruiting

Liguria

IRCCS Ospedale Policlinico San Martino, Genoa, Liguria, 16132, Italy
Dario Arnaldi, Md, PhD, Contact, +39 010 5557130, [email protected]
Recruiting

Lombardy

IRCCS Ospedale San Raffaele, Milan, Lombardy, 20132, Italy
Luigi Ferini-Strambi, Md, PhD, Contact, +39 0226433383, [email protected]
Sara Marelli, Contact, [email protected]
Recruiting
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS, Pavia, Lombardy, 27100, Italy
Michele Terzaghi, Md, PhD, Contact, +39.0382.380335, [email protected]
Recruiting

Sardinia

Azienda Ospedaliero-Universitaria di Cagliari, Cagliari, Sardinia, 09124, Italy
Monica Puligheddu, Md, PhD, Contact, 070486624, [email protected]
Recruiting

Sicily

I.R.C.C.S. Associazione Oasi Maria SS. - Ospedale Classificato, Troina, Sicily, 94018, Italy
Giuseppe Lanza, Md, PhD, Contact, +39 0935 936111, [email protected]
Recruiting

Tuscany

Azienda Ospedaliero Universitaria Pisana, Pisa, Tuscany, 56124, Italy
Michelangelo Maestri, Md, PhD, Contact, +39 050 995519, [email protected]
Recruiting

Veneto

Azienda Ospedaliera Universitaria Integrata Verona, Verona, Veneto, 37134, Italy
Recruiting