An observational study in REM Sleep Behavior Disorder and Neurodegenerative Diseases, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-24.
Sponsored by Chinese University of Hong Kong · Observational
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.
Among the 11 studies in REM Sleep Behavior Disorder by Chinese University of Hong Kong, this one is the 11th largest by enrollment, is one of 2 that started in 2017, is one of 11 observational ones, and was the 1st registered.
101 studies on the registry are indexed under REM Sleep Behavior Disorder; 45 are open to participants now.
Browse REM Sleep Behavior Disorder studies →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:
Chinese University of Hong Kong · Sites in Hong Kong
Chinese University of Hong Kong · Sites in Hong Kong
Ages 45–65 · Healthy volunteers
Chinese University of Hong Kong · Sites in Hong Kong
Ages 40–65 · Healthy volunteers
Chinese University of Hong Kong · Sites in Hong Kong
Ages 50+ · Healthy volunteers
By country, each count listing its studies:
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: 45 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 2 started in 2017.
This study's enrollment of 50 is below the median of 119 across 48 observational studies indexed under REM Sleep Behavior Disorder.
Median enrollment 400 across the 11 observational studies. Of the 4 that completed or were terminated, 0 (0%) have results posted.
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Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in REM Sleep Behavior Disorder by Chinese University of Hong Kong, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Background:
Previous studies have confirmed that most patients with idiopathic REM sleep behaviour disorder (iRBD) eventually develop neurodegenerative diseases. In addition, REM sleep without atonia (RSWA), a hallmark of RBD feature, is a significant predictor of development of neurodegenerative diseases in patients with iRBD. Some preliminary studies have implied that isolated RSWA in the absence of RBD symptoms may also indicate neurodegeneration. However, this speculation needs to be confirmed by more refined study with sophisticated measures in both RSWA and markers of neurodegeneration
Objectives: 1) to determine the differences in striatal dopamine transmission and other markers of neurodegeneration among individuals with isolated RSWA and healthy controls; 2) to examine the correlation of severity of RSWA with striatal dopamine transmission.
Design: Case-control study
Setting: Community-based sample
Participants: 1) iRBD first degree relatives with isolated RSWA (n=18) 2) iRBD first degree relatives without isolated RSWA (n=18) 3) Community-based health controls without isolated RSWA (n=18)
Main outcome measures:
In the past two decades, a number of studies have confirmed that most patients with idiopathic RBD will eventually develop neurodegenerative diseases, especially α-synucleinopathies. Previous studies, including our preliminary data, suggested that RSWA is a marker of predicting the conversion of neurodegenerative diseases in idiopathic RBD. In other words, RSWA is an early marker of neurodegeneration in patients with idiopathic RBD. However, a number of individuals who are absent of any RBD symptoms (including patients with α-synucleinopathies, also have RSWA, which is described to have isolated RSWA. Only a few studies have attempted to understand the clinical importance and predictive prognosis of isolated RSWA. These preliminary studies suggest that isolated RSWA in healthy subjects may be a silent biomarker of neurodegeneration. However, these preliminary findings need to be replicated and confirmed by more refined study with dopamine neurotransmission neuroimaging.
This proposed study will enrich the limited scientific literature of the potential pathogenesis and progression of isolated RSWA. By using an ongoing family study, we have screened a number of individuals with isolated RSWA, who are the first degree relatives of patients with RBD and are presumed to have a higher risk of neurodegeneration. Based on the existing sample, the current study will provide the first neuroimaging data on isolated RSWA to test the hypothesis that isolated RSWA, even in the absence of RBD symptoms, is an early marker of neurodegeneration. Individuals with isolated RSWA are expected to show dopamine dysfunction when compared with individuals without RSWA. If we confirm this hypothesis, the findings in the current study will extend our understanding of the spectrum of RBD and RSWA. The potential implication of our findings is that asymptomatic RSWA, especially in the presence of family history, will harbour the neurodegenerative progression. The results will pave the way for future prospective follow up to determine the course of neurodegeneration. From an etiological understanding, it will help to expand the understanding of the evolution course of synucleinopathy neurodegeneration. From an interventional angle, this study will have significant implication for developing a longer prevention window for neuroprotective trial.
The inclusion criteria for the subjects:
iRBD first degree relatives with isolated RSWA
Community-based health controls without isolated RSWA:
Subjects will be identified and recruited from our previous cohort.
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.
Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. No family history of RBD; 2. Age- and sex- matched with isolated RSWA subjects 3. Absence of dream enactment behaviors; 4. A score of RBDQ-HK less than 19; 5. Absence of RSWA as measured by v-PSG; 6. for those individuals with moderate obstructive sleep apnea (AHI \> 15/hour), effective CPAP treatment should be documented and a second night of V-PSG is required to determine RSWA.
1. First degree relatives of patients with iRBD; 2. Age 45 years or above; 3. Absence of dream enactment behaviors; 4. A total score on REM Sleep Behavior Questionnaire (RBDQ-HK) less than 19, which is the cut-off suggestive of a diagnosis of RBD; 5. Presence of RSWA as measured by v-PSG; RSWA is defined as the percentage of increased EMG activity (phasic or tonic) at least 10% during REM sleep for any channel. 6. for those individuals with moderate to severe obstructive sleep apnea (apnea-hypopnea index, AHI \> 15/hour), effective CPAP treatment should be documented and a second night of V-PSG is required to determine RSWA.
1. First degree relatives of patients with iRBD; 2. Age- and sex- matched with isolated RSWA subjects; 3. Absence of dream enactment behaviors; 4. A score of RBDQ-HK less than 19; 5. Absence of RSWA as measured by v-PSG; 6. for those individuals with moderate obstructive sleep apnea (AHI \> 15/hour), effective CPAP treatment should be documented and a second night of V-PSG is required to determine RSWA.
Dopamine neurotransmission
PET dopamine neurotransmission with a specific interest in striatal dopamine transmission
Time frame: 24 months
REMREEA
Correlations of severity of REMREEA with dopamine transmission, brain glucose metabolism, and neurocognitive measures.
Time frame: 24 months
Plan to share: Undecided — In this stage, we didin't decide which information of IPD will share with other researchers
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Jul 2019, 20 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong →