Unmet Needs Among Patients With Isolated REM Sleep Behavior Disorder (iRBD) and Their Significant Others
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversita di Verona
About this trial
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 to information, and interactions with healthcare services;
report information about emotional well-being, quality of life, and concerns related to the possible future progression of the disorder;
caregivers or significant others will complete a parallel questionnaire focused on their experiences, caregiving burden, informational needs, and perceived support.
The information collected in this study will help clinicians and researchers better understand the real-world needs of individuals living with isolated REM Sleep Behavior Disorder and their families. The results may contribute to improving patient education, clinical care pathways, and support services for this population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients with RBD who have already phenoconverted to a neurodegenerative disorder.
Patients or partners/family members without access to an email address.
Trial population
Adults diagnosed with isolated REM Sleep Behavior Disorder (iRBD) recruited at participating sleep and movement disorders centers, and their significant others or caregivers. Patients are identified during routine clinical care and invited to participate in the study together with a family member or significant other. Both patients and caregivers complete structured questionnaires assessing informational needs, psychosocial impact, and experiences related to the diagnosis and management of iRBD.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 2 trial groupsGroup A: Patients with isolated REM Sleep Behavior Disorder
Group B: Caregivers or significant others of patients with isolated REM Sleep Behavior Disorder
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (single assessment at questionnaire completion)Secondary outcomes
1
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.
Time frame
Baseline (single assessment at questionnaire completion)Sponsors and contacts
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Source ClinicalTrials.gov