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

NCT07498452 | Recruiting

• 1 other identifier: UN-RBD/SO
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 8

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 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.

Conditions

REM Sleep Behavior Disorder; Isolated REM Sleep Behavior Disorder

Keywords

iRBD; REM Sleep Behavior Disorder; Prodromal Parkinsonism; Patient Needs; Sleep Disorders

Outcome Measures

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.

  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

  Baseline (single assessment at questionnaire completion)

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with RBD who have already phenoconverted to a neurodegenerative disorder.
• Patients or partners/family members without access to an email address.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (8)

IRCCS Istituto delle Scienze Neurologiche di Bologna

Bologna, Emilia-Romagna, 40139, Italy

RECRUITING

IRCCS Ospedale Policlinico San Martino

Genoa, Liguria, 16132, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

RECRUITING

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, Lombardy, 27100, Italy

RECRUITING

Azienda Ospedaliero-Universitaria di Cagliari

Cagliari, Sardinia, 09124, Italy

RECRUITING

I.R.C.C.S. Associazione Oasi Maria SS. - Ospedale Classificato

Troina, Sicily, 94018, Italy

RECRUITING

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, 56124, Italy

RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Veneto, 37134, Italy

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

REM Sleep Behavior Disorder; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Elena Antelmi, Md, PhD

CONTACT

+39 0458124290; elena.antelmi@univr.it

Giacomo Carollo, MSc

CONTACT

giacomocarollo.2@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 27, 2026
• Study Start: May 6, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

IT (8)