REM Sleep Behavior DisorderNCT07498452
Unmet Needs Among Patients With Isolated REM Sleep Behavior Disorder (iRBD) and Their Significant Others
An observational study of REM Sleep Behavior Disorder and Isolated REM Sleep Behavior Disorder, run by Universita di Verona at 8 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- REM Sleep Behavior Disorder, Isolated REM Sleep Behavior Disorder
- How many people
- 150 participants
- Where
- 8 sitesItaly
- Study dates
- 6 May 2025to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with RBD who have already phenoconverted to a neurodegenerative disorder.
- Patients or partners/family members without access to an email address.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Giacomo Carollo, MSc contact
8 sites in 1 country
Italy8 sites, 8 recruiting
- Recruiting
IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, Emilia-Romagna, 40139
Giuseppe Plazzi, Md, PhD, +39 051 4966924, giuseppe.plazzi@unibo.it
- Recruiting
Azienda Ospedaliero-Universitaria di Cagliari
Cagliari, Sardinia, 09124
Monica Puligheddu, Md, PhD, 070486624, puligheddu@unica.it
- Recruiting
IRCCS Ospedale Policlinico San Martino
Genoa, Liguria, 16132
Dario Arnaldi, Md, PhD, +39 010 5557130, dario.arnaldi@unige.it
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132
Luigi Ferini-Strambi, Md, PhD, +39 0226433383, ferinistrambi.luigi@hsr.it
Sara Marelli, marelli.sara@hsr.it
- Recruiting
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, Lombardy, 27100
Michele Terzaghi, Md, PhD, +39.0382.380335, michele.terzaghi@unipv.it
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56124
Michelangelo Maestri, Md, PhD, +39 050 995519, Maestri74@gmail.com
- Recruiting
I.R.C.C.S. Associazione Oasi Maria SS. - Ospedale Classificato
Troina, Sicily, 94018
Giuseppe Lanza, Md, PhD, +39 0935 936111, glanza@oasi.en.it
- Recruiting
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Veneto, 37134
About this study
Official title: 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:
Read more
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.
Read the 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.
- Keywords
- iRBD, REM Sleep Behavior Disorder, Prodromal Parkinsonism, Patient Needs, Sleep Disorders
- Medical subject headings
- REM Sleep Behavior Disorder, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (single assessment at questionnaire completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start6 May 2025
- Primary completionMay 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for REM Sleep Behavior DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Antelmi, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498452
- Sponsor's protocol ID
- UN-RBD/SO
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 37046409Gossard 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.
PubMed 36259668Ingravallo 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.
PubMed 38341655Mahmood 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.
PubMed 32375913
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Unmet Needs Among Patients With Isolated REM Sleep Behavior Disorder (iRBD) and Their Significant Others: A Multicenter Cross-Sectional Survey Study
- ClinicalTrials.gov ID
- NCT07498452
- Acronym / sponsor ID
- UN-RBD/SO
- Keywords
- iRBD, REM Sleep Behavior Disorder, Prodromal Parkinsonism, Patient Needs, Sleep Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 6 May 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with RBD who have already phenoconverted to a neurodegenerative disorder.
- Patients or partners/family members without access to an email address.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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.
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 37046409Perez-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.
- Background: PubMed 36259668Gossard 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.
- Background: PubMed 38341655Ingravallo 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.
- Background: PubMed 32375913Mahmood 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giacomo Carollo, MSc contact
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of REM Sleep Behavior Disorder and Isolated REM Sleep Behavior Disorder, run by Universita di Verona at 8 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Antelmi, Md, PhD (+39 0458124290, elena.antelmi@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07498452, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.