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

NCT05353881 | Recruiting

• 1 other identifier: RGC14107520
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

REM Sleep Behavior Disorder

Keywords

Striatal dopamine; REM sleep without atonia; Prodromal markers

Outcome Measures

Primary Outcomes (1)

• Prevalence of Parkinson's Disease

  overall probability of prodromal PD based on the MDS research criteria for prodromal PD

  1 year

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The recruiting ability for the current study is further evidenced by a series of studies and publications in the past few years. For example, in our ongoing case-control family study, the investigator have recruited 89 control proband and 64 their FDRs who have all underwent v-PSG (Liu et al, Annals of Neurology 2019). By now, the investigator have expanded the number to 103 control probands and 91 FDRs. The investigator believe that this cohort will help us to recruit sufficient number of control subjects in this proposed study.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Shatin Hospital

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

REM Sleep Behavior Disorder

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Yun Kwok Wing, Professor

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mandy Yu, MPH

CONTACT

852-39197593; mandyyu@cuhk.edu.hk

Steven Chau, Doctor

CONTACT

852-39197792; stevenwaihochau@cuhk.edu.hk

Study Design

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

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: April 29, 2022
• Study Start: January 3, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

HK (1)