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

Official title

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

Overview

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.

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, individuals diagnosed with iRBD often face uncertainty and psychological distress related to the potential future development of neurodegenerative disease.

Despite growing scientific and clinical interest in iRBD, relatively little attention has been dedicated to the experiences, informational needs, and psychosocial burden associated with the diagnosis, both for patients and for their significant others or caregivers. Understanding these aspects is essential for improving patient-centered care, communication strategies, and support services.

The present study is a multicenter cross-sectional observational study designed to investigate the unmet needs, perceived challenges, and psychosocial impact associated with iRBD. The study involves several sleep and movement disorders centers and aims to collect structured data from individuals diagnosed with iRBD and from their significant others.

Participants will complete structured questionnaires administered through an online survey platform. The questionnaires collect information on multiple domains, including disease-related knowledge, perceived informational needs, interactions with healthcare services, emotional well-being, quality of life, and concerns about disease progression. Significant others or caregivers will complete a parallel questionnaire addressing caregiving experiences, perceived burden, informational needs, and support resources.

The data collected in this study will provide important insights into the real-world experiences of individuals living with iRBD and their families. The results may contribute to the development of targeted educational resources, improved clinical communication strategies, and support interventions aimed at addressing the unmet needs of this population.

Primary outcome measures

• Unmet informational, clinical, and psychosocial needs in patients with isolated REM Sleep Behavior Disorder and their significant others [Time frame: Baseline (single assessment at questionnaire completion)]

Secondary outcome measures (1)

• Identification of areas for improvement in healthcare services and informational resources for patients with isolated REM Sleep Behavior Disorder [Time frame: Baseline (single assessment at questionnaire completion)]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Italy · 8 centers

• IRCCS Istituto delle Scienze Neurologiche di Bologna — Bologna
• IRCCS Ospedale Policlinico San Martino — Genoa
• IRCCS Ospedale San Raffaele — Milan
• Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS — Pavia
• Azienda Ospedaliero-Universitaria di Cagliari — Cagliari
• I.R.C.C.S. Associazione Oasi Maria SS. - Ospedale Classificato — Troina
• Azienda Ospedaliero Universitaria Pisana — Pisa
• Azienda Ospedaliera Universitaria Integrata Verona — Verona

Publications

• Perez-Carbonell L, Simonet C, Chohan H, Gill A, Leschziner G, Schrag A, Noyce AJ. The Views of Patients with Isolated Rapid Eye Movement Sleep Behavior Disorder on Risk Disclosure. Mov Disord. 2023 Jun;38(6):1089-1093. doi: 10.1002/mds.29403. Epub 2023 Apr 12. PMID 37046409
• Gossard TR, Teigen LN, Yoo S, Timm PC, Jagielski J, Bibi N, Feemster JC, Steele T, Carvalho DZ, Junna MR, Lipford MC, Tippmann Peikert M, LeClair-Visonneau L, McCarter SJ, Boeve BF, Silber MH, Hirsch J, Sharp RR, St Louis EK. Patient values and preferences regarding prognostic counseling in isolated REM sleep behavior disorder. Sleep. 2023 Jan 11;46(1):zsac244. doi: 10.1093/sleep/zsac244. PMID 36259668
• Ingravallo F, D'Alterio A, Rossetti A, Antelmi E, Plazzi G. Disclosing the Risk Associated with Isolated REM Behavior Disorder: The Sleep Experts' Perspective. Mov Disord Clin Pract. 2024 May;11(5):488-495. doi: 10.1002/mdc3.13998. Epub 2024 Feb 11. PMID 38341655
• Mahmood Z, Van Patten R, Nakhla MZ, Twamley EW, Filoteo JV, Schiehser DM. REM Sleep Behavior Disorder in Parkinson's Disease: Effects on Cognitive, Psychiatric, and Functional outcomes. J Int Neuropsychol Soc. 2020 Oct;26(9):894-905. doi: 10.1017/S1355617720000430. Epub 2020 May 7. PMID 32375913

Identifiers

NCT: NCT07498452 · UN-RBD/SO

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗