Prodromal Markers in Recurrent Dream Enactment Behaviors Without REM Sleep Without Atonia

NCT ID: NCT05353881

Last Updated: 2024-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-03

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

REM sleep behavior disorder is a novel and distinct parasomnia characterized by recurrent dream enactment behaviors (DEBs) and REM sleep without atonia (RSWA) during polysomnographic assessment, with a male predominance and typical onset age at early 60's. The majority of patients with idiopathic RBD (iRBD) will eventually develop α-synucleinopathy, for instance Parkinson's disease (PD). Thus, iRBD has been considered as a highly specific precursor of α-synucleinopathy-related neurodegeneration. Recently, increasing studies have found that some participants present with only RSWA or DEBs (but without sufficient RSWA), which does not meet the diagnostic criteria for RBD. It has been suggested that these participants with subclinical features (either DEBs or RSWA) might represent a condition known as prodromal RBD. Several emerging evidence, including our own study, have implied a link between isolated RSWA (RSWA without DEBs) and markers of α-synucleinopathy-related neurodegeneration. However, it is still unclear whether the other condition related to RBD, i.e. recurrent DEBs but without sufficient RSWA, is related to a certain degree of α-synucleinopathy. In this regard, the novel concept of recurrent DEBs but without sufficient RSWA, also termed as prodromal/isolated RBD by some researchers, requires validation by further evidence in terms of clinical feature and neurodegenerative prodromal markers perspectives.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This proposed study is a case-control study, which aims to determine whether recurrent DEBs but without sufficient RSWA represents an early stage of α-synucleinopathy. The investigators will recruit 62 participants with recurrent DEBs but without sufficient RSWA and their age-, sex- matched controls from the community and on-going projects. All participants will undergo clinical interview, comprehensive measures of prodromal markers of neurodegeneration (including excessive daytime sleepiness, olfactory functioning, constipation, erectile dysfunction, urinary dysfunction, symptomatic hypotension, depression, and clinical motor markers) as suggested by the International Parkinson and Movement Disorder Society (MDS) research criteria. In addition, a subset of the sample (n = 26 in each group) will undergo the triple-tracer positron emission tomography/computed tomography (PET/CT) imaging protocol of 18F-DOPA, to determine dopamine functions in putamen. This proposed study will help to disentangle the core features of RBD and validate the concept of prodromal RBD with reference to prodromal markers related to α-synucleinopathy neurodegeneration.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

REM Sleep Behavior Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age between 45 and 65 years old
* RBDQ-HK behavior factor greater \> 8
* Recurrent DEBs by interview and/or video analysis
* Absence of sufficient RSWA

Exclusion Criteria

* Age- and sex- matched with cases
* RBDQ-HK behavior factor \< 8
* No DEBs by either interview or video analysis
* Absence of sufficient RSWA
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Professor Wing Yun Kwok

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yun Kwok Wing, Professor

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shatin Hospital

Shatin, , Hong Kong

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mandy Yu, MPH

Role: CONTACT

852-39197593

Steven Chau, Doctor

Role: CONTACT

852-39197792

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mandy Yu, MPH

Role: primary

852-26367593

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RGC14107520

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

RBD Longitudinal as Prognostic for PD
NCT00817726 ACTIVE_NOT_RECRUITING
Gait and REM Sleep Behavior Disorder
NCT02554331 TERMINATED NA
Neuroplasticity in RBD
NCT05471960 RECRUITING NA
Sleep, Awake & Move - Part II
NCT02710487 COMPLETED NA