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

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

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.

Study Overview

• Status: Recruiting
• Conditions: REM Sleep Behavior Disorder; Isolated REM Sleep Behavior Disorder

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Elena Antelmi, Md, PhD; Phone Number: +39 0458124290; Email: elena.antelmi@univr.it
• Study Contact Backup: Name: Giacomo Carollo, MSc; Email: giacomocarollo.2@gmail.com

Study Locations

• Italy
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40139
      • Recruiting
      • IRCCS Istituto delle Scienze Neurologiche di Bologna
      • Contact: Giuseppe Plazzi, Md, PhD; Phone Number: +39 051 4966924; Email: giuseppe.plazzi@unibo.it
  • Liguria
    • Genoa, Liguria, Italy, 16132
      • Recruiting
      • IRCCS Ospedale Policlinico San Martino
      • Contact: Dario Arnaldi, Md, PhD; Phone Number: +39 010 5557130; Email: dario.arnaldi@unige.it
  • Lombardy
    • Milan, Lombardy, Italy, 20132
      • Recruiting
      • Irccs Ospedale San Raffaele
      • Contact: Luigi Ferini-Strambi, Md, PhD; Phone Number: +39 0226433383; Email: ferinistrambi.luigi@hsr.it
      • Contact: Sara Marelli; Email: marelli.sara@hsr.it
    • Pavia, Lombardy, Italy, 27100
      • Recruiting
      • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
      • Contact: Michele Terzaghi, Md, PhD; Phone Number: +39.0382.380335; Email: michele.terzaghi@unipv.it
  • Sardinia
    • Cagliari, Sardinia, Italy, 09124
      • Recruiting
      • Azienda Ospedaliero-Universitaria di Cagliari
      • Contact: Monica Puligheddu, Md, PhD; Phone Number: 070486624; Email: puligheddu@unica.it
  • Sicily
    • Troina, Sicily, Italy, 94018
      • Recruiting
      • I.R.C.C.S. Associazione Oasi Maria SS. - Ospedale Classificato
      • Contact: Giuseppe Lanza, Md, PhD; Phone Number: +39 0935 936111; Email: glanza@oasi.en.it
  • Tuscany
    • Pisa, Tuscany, Italy, 56124
      • Recruiting
      • Azienda Ospedaliero Universitaria Pisana
      • Contact: Michelangelo Maestri, Md, PhD; Phone Number: +39 050 995519; Email: Maestri74@gmail.com
  • Veneto
    • Verona, Veneto, Italy, 37134
      • Recruiting
      • Azienda Ospedaliera Universitaria Integrata Verona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time 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 Measure	Measure Description	Time 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)

Collaborators and Investigators

• Sponsor: Universita di Verona

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Sleep Disorders; REM Sleep Behavior Disorder; iRBD; Prodromal Parkinsonism; Patient Needs
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Parasomnias; REM Sleep Parasomnias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Wake Disorders; REM Sleep Behavior Disorder
• Other Study ID Numbers: UN-RBD/SO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No