ClinicalTrials.gg
CompletedNCT03671772Updated Aug 6, 2021

Progression of Prodromal Markers of α-synucleinopathy Neurodegeneration in the FDRs of Patients With RBD

An observational study in REM Sleep Behavior Disorder and Neurodegeneration, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-06.

Sponsored by Chinese University of Hong Kong · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
170
Ages
40 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 11 studies in REM Sleep Behavior Disorder by Chinese University of Hong Kong — 4 open to participants now, 4 under way, none of them phase 3. REM Sleep Behavior Disorder · Chinese University of Hong Kong.

Enrollment
8th of 11
170 · median 400
Started
2018
with 1 other
Observational
11 of 11
4 open now
Registered
4th of 11
by date

Among the 11 studies in REM Sleep Behavior Disorder by Chinese University of Hong Kong, this one is the 8th largest by enrollment, is one of 2 that started in 2018, is one of 11 observational ones, and was the 4th registered.

REM Sleep Behavior Disorder

101 studies on the registry are indexed under REM Sleep Behavior Disorder; 45 are open to participants now.

Browse REM Sleep Behavior Disorder studies →

Open to participants now

4 of the 11 studies in REM Sleep Behavior Disorder by Chinese University of Hong Kong are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

Who these studies take

Of the 32 REM Sleep Behavior Disorder studies recruiting now, 18 (56%) set no upper age limit and 4 (13%) stop at 75 or younger; 4 take children under 18; 17 take healthy volunteers.

This study: 40 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study summary

This study is a prospective study with a mean of 5-year follow-up interval, aims to monitor the progression of α-synucleinopathy neurodegeneration by the evolution of prodromal markers and development of clinical disorders in first-degree relatives (FDRs) of idiopathic REM Sleep Behavior Disorder (RBD) patients and healthy controls.

Read the detailed description

Idiopathic RBD is implicated as an integral part of progression of α-synucleinopathy neurodegeneration, and patients with idiopathic RBD have increased prevalence of non-motor symptoms (or prodromal markers) closely related to Parkinson's disease(PD). Moreover, the investigator's previous studies have further confirmed the familial aggregation of RBD, and first-degree relatives (FDRs) of RBD patients had more prodromal markers of Parkinson's disease compared with FDRs of healthy controls.

In these regards, current prospective study aims to map the progression and evolution of prodromal markers (including autonomic dysfunction, olfactory loss, color vision impairment, neurocognitive impairment, neuroimaging of dopamine dysfunction, daytime sleepiness and psychiatric disorders), onset of RBD, and neurodegenerative diseases. Finally, other markers, such as physical activity and circadian rhythm and tonic electromyography (EMG) activity level, which have been found to be reliably associated with Parkinson's disease or other neurodegenerative diseases. In this regard, it is also interesting to investigate whether these indicators will additionally predict the progression of prodromal markers of PD.

03

Conditions studied

  • REM Sleep Behavior Disorder
  • Neurodegeneration

Keywords

  • α-synucleinopathy
  • Neurodegeneration
  • Prodromal markers
  • REM sleep behavior disorder
04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The participants in this proposed study will be recruited from our on-going family cohort of RBD

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Chinese aged 40 or above;
  2. Being capable of giving for participation of the study;
  3. Sex-matched.

Exclusion criteria

Exclusion Criteria:

  1. Younger than 40 years old (as the supposed neurodegenerative process may not have occurred);
  2. Not capable of giving for participation of the study.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
170 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • FDRs of idiopathic RBD patients

    First-degree relatives of idiopathic RBD patients

  • FDRs of controls

    First-degree relatives of controls

06

What researchers measure

Primary outcomes

  1. Changes of the overall probability of prodromal Parkinson's disease in the FDRs of patients with RBD.

    Changes of the overall probability of prodromal Parkinson's disease will be calculated based on the Movement Disorder Society (MDS) research criteria for prodromal Parkinson's disease in the FDRs of patients with RBD.

    Time frame: Baseline and 5 years

Secondary outcomes

  1. Changes of tonic EMG activity in the FDRs of patients with RBD.

    Changes of tonic EMG activity is recorded by v-PSG in the FDRs of patients with RBD.

    Time frame: Baseline and 5 years

  2. Changes of physical activity level and circadian in the FDRs of patients with RBD.

    Changes of physical activity level and circadian are recorded by one-week actigraphy in the FDRs of patients with RBD.

    Time frame: Baseline and 5 years

  3. New incidence of RBD and α-synucleinopathy in the FDRs of patients with RBD.

    New incidence of probable RBD, video-polysomnography (v-PSG) confirmed definite RBD and α-synucleinopathies in the FDRs of patients with RBD.

    Time frame: Baseline and 5 years

07

Study locations

1 site
  • Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong
    Hong Kong, Hong Kong
08

References and documents

Individual participant data

Plan to share: Undecided — Researcher in other sleep centers are also conducting similar study, there may be a plan for further collaboration on sharing the database

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2018 to primary completion in Apr 2020, 19 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2018
First posted
Sep 14, 2018
StartActual
Sep 27, 2018
Primary completionActual
Apr 27, 2020
CompletionActual
Apr 27, 2020
Last update
Aug 6, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03671772
Responsible party
Dr. Zhang Jihui (Assistant Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Sep 14, 2018
Start date
Sep 27, 2018
Primary completion
Apr 27, 2020
Completion
Apr 27, 2020
Last update
Aug 6, 2021

Study contacts

Jihui Zhang, PhD
principal investigator · Chinese University of Hong Kong
Yun Kwok Wing, MBChB
study director · Chinese University of Hong Kong
Vincent Chung Tong Mok, MBChB
study director · Chinese University of Hong Kong
Shirley Xin Li, PhD
study director · Hong Kong University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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